Articles in "Pharma News"

Japan's Meiji Seika acquires Medreich

Japan's Meiji Seika has agreed to buy Bangalore-based generic drug maker Medreich for $290 million. The over nine-decade-old company has acquired a 75% stake held by Medreich's three promoters and the rest 25% from private equity investor Temasek. Th

Pfizer considers $100 billion bid for AstraZeneca

There is recent market speculation that Pfizer is looking for giant take over of London based pharma major Astra Zeneca, really shaken up the market in last 2 days. We have seen in the past, one of the most widely approached strategic growth path fo

Labeling changes for Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate)

FDA approved changes to the Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) package insert. The major changes include restricting the indication to treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/

Sun Pharma to acquire Ranbaxy in $3.2 billion deal

Sun Pharmaceutical Industries Ltd said it will buy generic drug maker Ranbaxy Laboratories Ltd, which has hit regulatory snags in its key US market over quality issues, in an all-share deal with total equity value of $3.2 billion. ​Ranbaxy, India’s l

Case of USFDA New Drug Approval - Kynamro

The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (H

Piramal Enterprises posts net profit of Rs 61 cr in Q3

Piramal Enterprises' posted a sixfold growth in net profit to Rs 61.1 crore in the third quarter of financial year 2012-13 due to the revenue it earned from newly acquired foreign information management company Decision Resources Group.Consolidated n

Dr Reddy's unveils Finasteride tablets in American market

Pharma major Dr Reddy's Laboratories Ltd has announced the launch of Finasteride tablets, a bioequivalent generic version of Propecia (Finasteride) tablets in the American market.Dr Reddy's Abbreivated New Drug Application (ANDA) for Finasteride has

Glenmark gets USFDA approval for Mupirocin Calcium Cream

Pharma sector leader Glenmark Pharmaceuticals announced that it has got a green signal for marketing its skin disease treatment cream, Mupirocin Calcium Cream, across markets in the USA.The company is a subsidiary-arm of Glenmark Generics Ltd. The co

MDI Labs to invest Rs 150 cr in Indian unit

Largest German clinical laboratory, the Medizinisch Diagnostiche Institute (MDI) plans to invest Rs 150 crore in its Indian subsidiary. The company is also planning to achieve a turnover of Rs 350 crore in 2015. The expansion will be funded through i

New World Strategy Aims to Eradicate Polio by 2018

A new global plan aims to end most cases of polio by late next year, and essentially eradicate the paralyzing disease by 2018 — if authorities can raise the $5.5 billion needed to do the work ​Part of the challenge will be increasing security for vac

Boehringer Ingelheim launches Hep C online resource

Boehringer Ingelheim has launched HepCRedefined.com, an online portal to help improve the lives of those living with the hepatitis C virus (HCV) through education, information and understanding. The portal aims to redefine the HCV journey by providin

Shire and Boston Children's Hospital enter into broad research collaboration

Shire plc (LSE: SHP, NASDAQ: SHPG) and Boston Children's Hospital today announced a three-year, broad research collaboration in rare diseases. The goal of the collaboration is to develop novel therapies to treat a number of rare pediatric diseases

Singapore garnering Indian IT, pharma investments

Singapore is garnering more and more investments from India from pharmaceutical as well as IT sector.Singapore’s Economic Development Board (EDB) expressed, ''this year they will be garnering more Indian IT investments into Singapore as well as poten

FDA approves new drug Ravicti for the chronic management of some urea cycle disorders

The U.S. Food and Drug Administration today approved Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients ages 2 years and older.UCDs are genetic disorders that involve deficiencies of specific

FDA approves Gleevec for children with acute lymphoblastic leukemia

The U.S. Food and Drug Administration today approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, af

Bayer's Investigational Riociguat Granted U.S. FDA Priority Review

Bayer HealthCare announced today that the New Drug Application (NDA) for its oral investigational compound riociguat has been accepted for filing and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of inoperab

Shire Acquires Premacure AB

Shire plc, announces that it has acquired Premacure AB of Uppsala, Sweden, a privately held biotechnology company developing a protein replacement therapy, currently in Phase II development, for the prevention of retinopathy of prematurity (ROP). ROP

FDA grants priority review to Boehringer Ingelheim's Afatinib* NDA for EGFR mutation-positive advanced NSCLC

Boehringer Ingelheim today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib* has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for

New Research May Help Lead to HIV/AIDS Vaccine

In what may be an important advance in efforts to develop an HIV vaccine, scientists have analyzed one person's immune response to the virus to determine how a series of mutations created an antibody that can conquer many strains of HIV, which is the

Using fat to fight brain cancer

In laboratory studies, researchers say they have found that stem cells from a patient's own fat may have the potential to deliver new treatments directly into the brain after the surgical removal of a glioblastoma, the most common and aggressive form

NIH Scientists Discover Promising Target to Block Staphylococcus Infection

National Institutes of Health (NIH) scientists have identified a promising lead for developing a new type of drug to treat infection caused by Staphylococcus aureus, a bacterium that frequently resists traditional antibiotics. The researchers discove

International Conference on Traditional Medicine from Feb 12

Ministry of Health Family Welfare, Government of India and the Department of AYUSH, shall organize the International Conference on Traditional Medicine in collaboration with WHO-SEARO (South East Asia Regional Office). The conference is slated to ta

FDA approval of generic version of cancer drug Doxil is expected to help resolve shortage

Brand Name:DoxilDrug:​ Doxorubicin hydrochloride liposomeCategory: CancerDosage form: InjectionVersion: GenericApproved By: US FDAManufacturer/Supplier:Sun Pharma Global FZE (Sun)Route of Administration: Intravenously by a health care professionalDos

AstraZeneca launches new digital resources for ARIMIDEX® (anastrozole) tablets to help educate patients about ARIMIDEX Direct

Resources Provide Program Enrollment Information and Encourage Patients to Share the Information With Others AstraZeneca (NYSE: AZN) today launched new digital resources to educate patients on how to enroll in ARIMIDEX Direct. Resources include a “ho

No attention-boosting drugs for healthy kids, doctors urge

Doctors have called upon their fellow physicians to limit or end the practice of prescribing memory-enhancing drugs to healthy children whose brains are still developing.The statement was written to address the growing trend in which teens use "study

FDA Accepts NDA for OTREXUP™

Antares Pharma, Inc. announced that the New Drug Application (NDA) for OTREXUP™, a potential new product for the subcutaneous delivery of methotrexate (MTX) using Medi-Jet™ technology, has been accepted by the U.S. Food and Drug Administration (FDA)

Arrhythmia drug may increase cancer risk

One of the most widely used medications to treat arrhythmias may increase the risk of developing cancer, especially in men and people exposed to high amounts of the drug. The study's results indicate that a potential link between amiodarone and cance

Q4 Sales for Top 100 U.S. Drugs

At the close of 2012, Otsuka's antipsychotic Abilify overtakes AstraZeneca's acid reducer Nexium and moves into the number one spot with over$1.47 billionin quarterly sales. Sales expanded for all five front-runners over the quarter, although none re

GFDCA to establish mobile drug testing lab in 2013

In a bid to initiate spot testing for counterfeit drugs, the Gujarat Food and Drug Control Administration (GFDCA) shall establish a mobile drug-testing center this year. The laboratory shall come with an investment of about Rs 67 lakh. Budgetary prov

Cipla-Medpro strategic deal on hold

India's second-largest drugmaker has decided to put on hold its $220-million acquisition plan of the third-largest South African drugmaker Cipla Medpro due to valuation issues as reported by Economics Times. In November last year, Cipla had decided t

DCGI suggests plan to ensure GMP-compliant drug plant exporters

The Drug Controller General of India (DCGI) is drafting a plan that could ensure compliance of domestic bulk drug units exporting pharma products to the European Union. The compliance shall be weighed on the basis of World Health Organization (WHO) r

FDA Proposes Tighter Regulation of Public Defibrillators

To improve the quality of lifesaving devices called automated external defibrillators, the U.S. Food and Drug Administration proposed that the seven manufacturers of these devices be required to get agency approval for their products.Automated extern

Parkinsons' drug helps older people to make decisions

A drug widely used to treat Parkinson's Disease can help to reverse age-related impairments in decision making in some older people.Poorer decision-making is a natural part of the ageing process that stems from a decline in our brains' ability to lea

GlaxoSmithKline Plc and Biological Ejoint venture for the early-stage research and development of a six-in-one combination paediatric vaccine

GlaxoSmithKline Plc and Biological E Ltd said on Monday that they have signed an agreement to form an equal joint venture for the early-stage research and development of a six-in-one combination paediatric vaccine to help protect children in India an

Less Salt, More Potassium = Millions of Lives Saved

Reducing dietary salt intake and boosting levels of potassium would prevent millions of deaths from heart disease and stroke worldwide each year, according to three new studies. One study examined the findings of 34 clinical trials involving more tha

Lilly to Spend $260M on Indianapolis Expansion

Eli Lilly and Co. is planning to spend about $260 million to expand insulin production and make some other capital improvements to sites in its home city. The Indianapolis company aims to spend about $180 million on some new construction, the additio

Roche and Chiasma Announce Collaboration to Develop and Commercialize Chiasma's Octreolin for Acromegaly and Neuroendocrine Tumors

Roche and Chiasma Inc., a privately held biopharma company, announced today that they have entered into an agreement to develop and commercialize Chiasma's proprietary product Octreolin, initially for acromegaly and subsequently for neuroendocrine tu

New European patent court to be built in London

The UK business secretary has finalized a deal for a new one-stop European patent court to be based in London in 2015. Vince Cable signed the deal in Brussels for the court, which is expected to bring in over £200m the UK economy each year. "The new

Aspirin may lower melanoma risk

A new study has found that women who take aspirin have a reduced risk of developing melanoma (Melanomais the most dangerous type of skin cancer. It is the leading cause of death from skin disease.Melanomacan also involve the colored part of the eye)-

Novartis campaign to eliminate leprosy worldwide

Novartis advances goals set as part of a coordinated, international effort to eliminate or control 10 neglected tropical diseases (NTDs)Over 500 facilities in Tanzania now use SMS for Life to track the use and stock of leprosy medicines, and better m

MedImmune, AstraZeneca's biologics unit, acquires AlphaCore Pharma

AstraZenecaannounced that MedImmune, its global biologics research and development unit, has acquired AlphaCore Pharma, an Ann Arbor, Michigan-based biotechnology company focused on the development of ACP-501, a recombinant human lecithin-cholesterol

FDA Approves 'Bionic Eye' to Help Against Rare Vision Disorder

An implanted, sight-enhancing device some are calling a "bionic eye" is the first to gain approval for use in the United States, officials announced.According to the U.S. Food and Drug Administration, the new Argus II Retinal Prosthesis System can he

FDA approves Novartis' Simbrinza for glaucoma

Regulators in the USA have given the green light to Simbrinza, a glaucoma treatment developed by Novartis eye care unit Alcon.The US Food and Drug Administration has approved Simbrinza for the reduction of elevated intraocular pressure in patients wi

Breastfeeding for 6 Months Cuts Women's Risk of Cancer Death

Mothers who breastfeed for at least six months have a 10 percent lower risk of dying from cancer and a 17 percent lower risk of dying from circulatory disease.Researchers examined the habits of nearly 380,000 people in nine European countries and fou

Cipla to acquire South African firm Medpro for USD 512 mn

Indian pharma company Cipla has offered to buy out South African partner Cipla Medpro, paying around $512 million to expand into Africa where the demand for inexpensive drugs is growing exponentially. Johannesburg-listed Medpro is South Africa's thi

FDA Approves Diclegis for Pregnant Women Experiencing Nausea and Vomiting

The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting. Diclegis is a delayed-release tablet intended for women who have not adequatel

Novartis future growth prospects secured by industry-leading pipeline, with more than 139 projects with 73 new compounds

Novartis Pipeline Snapshots Novartis future growth prospects secured by industry-leading pipeline, with more than 139 projects with 73 new compoundsPharmaceuticals Division growth over the next 5 years expected to bedriven by portfolio of recently l

NIH awards SBIR grant to Ventria Bioscience & USC to develop fusion protein for diabetes treatment

The National Institutes of Health (NIH) has awarded a Small Business Innovation Research (SBIR) grant to Ventria Bioscience and the University of Southern California (USC), with the goal of developing a cost-effective method for producing clinical-gr

Medical device gets European nod for export

An indigenously manufactured haematology analyser has become the first Indian product in its category to got a certification for export to European markets.According to a statement by Trivitron Healthcare, Cellenium 19, the indigenously manufactured

India's Health Ministry Releases New Clinical Trials Requirements

India's Union Health Ministry has released a new rule requiring all ethics committees to be registered with licensing authorities, part of a broader effort to improve the quality of clinical trials in India, which have long been under fire by critics

Novartis loses patent case in India on its cancer drug Glivec

In a landmark judgement, the Supreme Court has turned down the Swiss pharma major Novartis' plea for a patent on its chronic myeloid leukaemia drug imatinib mesylate (Glivec). In this long-drawn patent battle with the government of India, the Swiss p

FDA Approves Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets for the Prevention of Pregnancy

Teva Pharmaceutical Industries Ltd.announced that the U.S. Food and Drug Administration (FDA) has approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy. Quartette represents the next gener

Genzyme’s AUBAGIO® Approved in Argentina for the Treatment of Relapsing MS

Genzyme, a Sanofi company, announced today Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral AUBAGIO® 14 mg as a new treatment indicated for patients with relapsing forms of multiple scler

FDA approves Pomalyst for advanced multiple myeloma

Drug: Pomalidomide ​Brand: Pomalyst ​Approved by: US FDA ​Treatment: Multiple myeloma ​Dosage form: Pill ​Description:Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone marrow. Acc

Bayer to collaborate with the Children's Hospital & Research Center Oakland to fight rare blood diseases

Bayer HealthCare has signed a master collaboration agreement with the California-based Children's Hospital Research Center Oakland to research hemoglobin disorders, particularly in the area of sickle cell anemia. The agreement aims to utilize promis

GSK forms partnership with Vodafone to help increase childhood vaccination in Mozambique

GSK has formed a partnership with Vodafone to harness innovative mobile technology to help vaccinate more children against common infectious diseases in Africa. Despite major advances in the funding and availability of vaccines worldwide, it is es

Otsuka's NDA for Tolvapta Accepted for Review by the FDA

Otsuka Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the company's new drug application (NDA) for the potential use of tolvaptan for the treatment of autosomal dominant polycystic

Now, an Indian effort to cut childhood vaccine prices

First, Indian generic drug firms gave the world anti-AIDS and anti-cancer drugs at less than half the global price. Now, another Indian company will help bring down global cost of immunising millions of the world's most vulnerable children against fi

New nanomedicine resolves inflammation, promotes tissue healing

A multicenter team of researchers has developed biodegradable nanoparticles that are capable of delivering inflammation-resolving drugs to sites of tissue injury. The nanoparticles, which were successfully tested in mice, have potential for the treat

FDA approves three new drug treatments for type 2 diabetes

On January 25, 2013, the U.S. Food and Drug Administration approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin

Japanese pharma firms keen on tie-ups with Indian companies

Japanese pharma companies are keen to collaborate with Indian pharma companies in trade and technology development, said Yasuhiko Shioi, president, Kokando Co. Ltd., leader of the Japanese pharmaceutical delegation to India.The meeting was organised

Boehringer Ingelheim and Apexigen sign manufacturing agreement

Boehringer Ingelheim Biopharmaceuticals, a global leader in the field of biopharmaceuticals manufacturing, and Apexigen, an emerging biopharmaceutical company dedicated to the discovery and development of best-in-class therapeutic monoclonal antibodi

USFDA to charge Indian cos Rs 30 lakh as generic drug fee

The US Food and Drug Authority (USFDA) has hiked the fee of pharma companies that need to pay for registration of generic drugs. With this move, Indian companies will have to pay the American health regulator Rs 30 lakh to attain license to sell gene

FDA approves TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients

The U.S. Food and Drug Administration approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.Cystic fibrosis is a genetic disease that

FDA Approves Kadcyla for Late-Stage Breast Cancer

HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast cancers, the increased amount of the HER2 protein contribut

Sanofi's Product Pipelines

Sanofi has provided an update on its Research Development (RD) pipeline with Dr. Elias Zerhouni, President, Global Research and Development, presenting at the JP Morgan Healthcare Conference in San Francisco, California.Highlights of the presentatio

FDA Approves Tris Pharma's New Drug Application for Karbinal ER

Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate

Boehringer Ingelheim's robust pipeline in Respiratory R&D

At its 3rd International Research Development press conference, Boehringer Ingelheim unveiled a pipeline of unique asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and lung cancer compounds that builds on

Novartis Lung Cancer Drug Gets Key FDA Designation

Novartis AG- Its experimental cancer drug LDK378 was designated as a breakthrough therapy by the Food and Drug Administration. The Swiss drugmaker is studying LDK378 as a treatment for a rare type of metastatic non-small cell lung cancer. It is inten

Abbott announces international launch of the Absorb(TM)

Abbott (NYSE: ABT) announced that Absorb(TM), the world's first drug eluting bioresorbable vascular scaffold (BVS), is now widely available across Europe and parts of Asia Pacific and Latin America. Absorb is a first-of-its-kind device for the treatm

FDA warns Tennessee company that online product claims violate federal law

False claims include “benefits for fungal meningitis, concussions, and other diseases”The U.S. Food and Drug Administration today issued a Warning Letter to The Avalon Effect Inc., a company based in Franklin, Tenn., for its marketing of a light ther

Gulf countries eyeing Indian investment in pharma sector

With an eye to get benefit from India's experience in the generics segment, a number of Gulf Cooperation Council (GCC) nations are looking at investments from Indian pharmaceutical companies. The GCC pharmaceutical Industry Outlook, signing of the im

New monoclonal antibody developed that can target proteins inside cancer cells

Researchers have discovered a unique monoclonal antibody that can effectively reach inside a cancer cell, a key goal for these important anticancer agents, since most proteins that cause cancer or are associated with cancer are buried inside cancer c

Nigeria, Algeria offer excellent export opportunities for Indian pharma

Nigeria and Algeria are on the radar of Indian pharma cos, as they offer excellent export opportunities for the Indian firms. After South Africa, Nigeria and Algeria have emerged as leading importers of pharmaceutical products from India and to furth

DIPP looks for details on 3 cancer drugs for compulsory licensing

With an aim to begin the process for a possible issuance of compulsory licences for anti-cancer drugs, the Department of Industrial Policy and Promotion (DIPP) has sought details from the Health Ministry regarding three medicines sold by multi-nation

Rare Disorders Without Borders - An International Strategy

February 28, 2013 marks the sixth international Rare Disease Day coordinated by EURORDIS and organized with rare disease national alliances in 24 European countries. On and around this day hundreds of patient organizations from more than 60 countries

Uniform codes of Pharmaceutical Marketing Practices

This is a voluntary code of Marketing Practices for Indian PharmaceuticalIndustry , for the present and its implementation will be reviewed after a period ofsix months from the date of its coming into force and if it is found that it has notbeen impl

Novo Nordisk planning launch of Tresiba in India

Danish pharmaceutical major Novo Nordisk, on Monday, said it would soon launch its insulin injection Tresiba (insulin degludec) in India. Novo Nordisk is the leading manufacturer of insulin in the world, and Tresiba, the new basal insulin, is used fo

Collegium Pharma gets USPTO notice of allowance for patent covering Oxycodone DETERx drug delivery technology

The US Patent and Trademark Office (USPTO) has issued Notice of Allowance to Collegium Pharmaceutical's patent application "Abuse-Deterrent Drug Formulation" US Patent Application Number 12/823,628. This will be the third issued patent related to the

SRM University to commercialise patented diabetic drug

SRM University plans to commercialize its US patented herbal diabetic drug in around six months time, said the private varsity's vice chancellor.Speaking to IANS, Vice Chancellor M. Ponnavaikko said: "We have incorporated a company called SRM Pharma

US Patent Office Grants Additional Patent Protection for Biogen Idec’s TECFIDERA™

Biogen Idec announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 8,399,514, which offers additional protection for TECFIDERA™ (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multip

U.S. Pharmaceutical Sales - Q4 2012

The following is a list of the top 100 prescribed medicines by U.S. National Sales in Q4 2012. Figures include sales through both retail and hospital channels, listed by drug name and sales value in U.S. dollars. Top 100 Drugs for Q4 2012 by Sales

FIXED DOSE COMBINATIONS APPROVED BY DCG (I) SINCE 1961 TILL FEBRUARY, 2013

PLEASE FIND THE ATTACHED DOCUMENT IN ATTACHMENTS OR CLICK HERE​

Cost of Diabetes Care in U.S. Keeps Climbing

The total cost of diabetes in the United States jumped from $174 billion in 2007 to $245 billion in 2012 Last year's total cost included $176 billion in direct medical costs -- such as hospital and emergency care, medications and office visits -- an

GSK and Theravance New Drug Application (NDA) Submission in USFDA for ANORO ELLIPTA(TM) for COPD

GlaxoSmithKline plc and Theravance, Inc. today announced that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted

Mylan Launches First Generic Maxalt MLT® Tablets

Mylan Inc.(Nasdaq: MYL) today announced that its subsidiaryMylan Pharmaceuticalshas received final approval from theU.S. Food and Drug Administration(FDA) for its Abbreviated New Drug Applications (ANDA) for Rizatriptan Benzoate Orally Disintegrating

Torrent is set to acquire Mumbai-based Elder Pharma's entire domestic formulations business for 2000 crores

Significance: Major Indian company acquiring another Indian company. Why this deal? Elder's strong brand portfolio containing leading brands like Shecal, chymoral brand. Total brand value of Elder is around 400 crores. Deal value is 5 times of the

Novartis collaboration aims to eliminate rheumatic heart disease (RHD) in Zambia, Africa

Novartis announced that it has launched an effort to eliminate rheumatic heart disease in Zambia in collaboration with the Lusaka University Teaching Hospital (UTH), the Ministry of Health in Zambia, the Pan-African Cardiology Society and Massachuse

FDA Approves Sitavig

BioAlliance Pharma's Sitavig Receives FDA Approval for the Treatment of Herpes LabialisBioAlliance Pharma SA (Euronext Paris - BIO), announced the receipt of marketing authorization from the U.S. Food and Drug Administration (FDA) for Sitavig in the

Slow down hits in indian pharma market... rises concern

Total Pharma market - 72000 Crs DeGrowth in August (- ) 1.8% DeGrowth in September - (- )1.8% Recording its first negative growth in September, the Indian drug market shrank by 1.8 per cent. Products under the drug pricing control net have shrunk by

Piramal unit and IBA Molecular ink pact for European, US markets with 18F-Florbetaben

Piramal Imaging SA, part of Pirmal Enterprisesentered into a pact with IBA Molecularfor manufacture and distribution of its diagnostic imaging agent 18F-Florbetaben in the European and US markets. Under the agreement, IBA Molecular will be respons

FDA Accepts Merck’s NDA for an Investigational Tablet Formulation of the Antifungal NOXAFIL® (posaconazole)

Merck has announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL ® (posaconazole), has been accepted for review by the U.S. Food and Drug Administration (FDA). Merck currently mar

Sanofi launch sub-brands of its well-known products

Drug maker Sanofi India, a unit of France's Sanofi, consider launching sub-brands of its well-known brands like Avil, Soframycin and Sea CodThe firm has recently launched sub-brand Combiflam Plus in the market after launching pain relief cream Combif

US FDA allows Scioderm's IND application for SD-101 for treatment of epidermolysis bullosa

Scioderm, a privately held, clinical-stage pharmaceutical company, announced that the US Food and Drug Administration (FDA) has reviewed and allowed its investigational new drug (IND) application for SD-101 to proceed. SD-101 is a topical treatment b

USFDA approved first generic version of the Singulair

The U.S. Food and Drug Administration said that on Friday it approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.

Natco takes on Bristol Myers Squibb with blood cancer generic drug.

In a move which is sure to kick off a fresh controversy in the regulatory framework over patent issues, Hyderabad-based Natco Pharma has launched Bristol Myers Squibb's (BMS) cancer drug Dasatinib, under the brand name of Sprycel. Natco has received

Issues with Vitamin D supplementation

Many vitamin D supplements may not contain what their label says they doSome pills may pack a lot more vitamin D than the label states, and others may provide markedly lessThe researchers are more concerned by pills delivering too little of the vitam

Orchid posts net loss of Rs 72 cr in Q3

Orchid Pharmaceuticals and Chemicals reported 33 per cent fall in its net revenue, widening its net loss to Rs 72 crore in the third quarter of the current fiscal.The pharma company attained revenue worth Rs 313 crore in the quarter compared to Rs 47

Tiny implants signal new way to treat cancer tumours

Cancer patients could be treated more effectively in future with tiny, sensory implants that will monitor tumours in real time and in great detail. The devices, about the size of an eyelash, would be implanted into patients' tumours. They would allow

FDA approves Invokana to treat type 2 diabetes

First in a new class of diabetes drugsThe U.S. Food and Drug Administration approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.Type 2 diabetes is the most common form of

Slow approvals put India’s clinical trials at risk

Slower government approval for testing new medicines is threatening India’s aspirations to be a fast-growing, low-cost hub for clinical trials, and has prompted some drugs firms to shift operations elsewhere, adding to their costs.Drugs firms complai

Roche ties with Emcure to produce two cancer drugs

The government has announced that Roche, Swiss drug major has entered into a joint venture with India's Emcure Pharma for locally producing two of its patented cancer drugs which could help in making the medicines affordable.The technology transfer p

Merck announces collaboration with nordic Bioscience for Sprifermin - Osteoarthritis of the Knee

Merck announced a strategic alliance with Nordic Bioscience Clinical Development A/S on Merck's investigational drug sprifermin (recombinant human FGF-18) in osteoarthritis (OA) of the knee. This agreement underscores Merck's commitment to osteoarthr

Cipla to invest Rs 500 cr to set up API facilities

Pharma major Cipla Ltd plans to invest Rs 500 crore for setting up an active pharmaceutical ingredients (API) facilities at Patalganga, Bengaluru and Kurkumbh. The setting up of these facilities is expected to be complete in 2012-13, the company sa

Ranbaxy recalled lipitor in US market

Ranbaxy Pharmaceuticals Inc. has recalled dozens of lots of its generic version of cholesterol drug Lipitor because some may contain tiny glass particles, the latest in a string of manufacturing deficiencies that once led U.S. regulators to bar im

What is the market size of Indian Pharmaceutical Industry in Crores?

Rs. 63,500 Crores

B-MS/AZ take over UK exenatide sales

Bristol-Myers Squibb and AstraZeneca have completed their deal with Eli Lilly to take over the commercialisation of diabetes drug exenatide - in the forms Byetta and Bydureon - in the UK.B-MS and AZ formed an alliance in 2007 to research, develop and

US FDA approves Mylan's lithium carbonate ER tablets

The US Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for lithium carbonate extended-release tablets USP, 450 mg. This product is indicated for the treatment of manic episodes of manic d

Wockhardt gets USFDA nod for tablets to check heart attack

Drug firm Wockhardt on Friday said it has received American health regulator's approval to market clopidogrel bisulfate tablets used for reducing risk of heart attack, in the US market. The company has received final approval from the US Food and Dr

Daiichi Sankyo, Eli Lilly TRILOGY ACS study fails to meet primary endpoint

Daiichi Sankyo Company and Eli Lilly and Company have announced that the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) study has failed to meet the primary endpoint. The Phase

FDA approves Stivarga for advanced gastrointestinal stromal tumors

The U.S. Food and Drug Administration expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments

USFDA frees Aurobindo Pharma's Hyderabad unit from import alert

Aurobindo Pharma Ltd said that US Food and Drug Administration (USFDA) has removed the import alert that it had earlier levied on the antibiotics unit at Hyderabad. This alert-removal permits Aurobindo Pharma for exporting nine of its products to the

More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief

US. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President's Emergency Plan for AIDS Relief (PEPFAR) to treat

Bausch + Lomb Completes the Acquisition of ISTA Pharmaceuticals

Bausch + Lomb, the global eye health company, announced today that it has completed its acquisition of ISTA Pharmaceuticals, Inc., a leading pharmaceutical company. The addition of ISTA bolsters Bausch + Lomb's product portfolio and pipeline, increas

Teva eyeing $10 Billion Market Depends on New Test of MS Drug

Teva Pharmaceutical Industries Ltd. (TEVA) is recruiting about 1,800 patients for a new trial of its multiple sclerosis pill in a bid to improve how the disease is treated and secure a successor to its best-selling medicine. The drug, laquinimod, i

Bristol-Myers Squibb Foundation Awards $1.6 Million in Grants to Help Communities in India Address Type 2 Diabetes

BMS announced $1.6 million in grants to four health care institutions in India that will help improve diabetes education, prevention and care and increase health care worker capacity in rural and tribal areas and among the urban poor. The prevalenc

Novartis drug Signifor® gains FDA approval as the first medication to treat Cushing's disease

Novartis announced that the US Food and Drug Administration (FDA) has approved Signifor® (pasireotide) injection for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative3. Sign

Revival of Wockhardt

Habil Khorakiwala, 70, chairman of generic drugmaker Wockhardt, says that the company's near-death experience has taught him lessons that he hopes will last generations. "We have decided not to touch derivative instruments. Some bankers still come

Statistics on Patent Applications/Granted at Indian Patent Office

Sun Pharma to acquire US-based DUSA for $230 mn

Sun Pharmaceutical Industries Thursday said it has inked a pact to acquire US-based DUSA Pharmaceuticals for around USD 230 million (around Rs 1,250 crore). Sun Pharma and DUSA Pharmaceuticals have entered into a definitive agreement under which Sun

Biocon and CCM deal: exclusive licence and distribution rights for its insulin products in Malyasia and Brune

Bangalore-based biotechnology firmBioconhas given CCM Pharmaceuticals, a subsidiary of Chemical Company of Malaysia, exclusive licence and distribution rights for its insulin products in Malyasiaand Brunei."The collaboration was in line with CCM's vi

Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose Lundbeck is engaged in the researc

Abbott launches dissolvable stents in India

Global pharma giant Abbottlaunched its "Bioresorbable Vascular Scaffold" in India. The product is a kind of stent or tube that is used to clear blockages and has been cleared by the Drugs Controller General of India (DCGI).Announcing the launch, Abbo

Mylan introduces modafinil tablets in US market

The US Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for modafinil tablets USP,100 mg and 200 mg. This product is the generic version of Cephalon's Provigil tablets and is indicated to

Social Media Marketing in Pharmaceuticals: Unclear regulation prevails

Companies that go looking for reasons not to monitor and engage with social media sometimes wind up with what sound more like excuses: rigid cultures, time constraints, organizational siloes, and so forth. But one common objection that is harder to o

USFDA First-Time Generic Drug Approvals - June 2012

Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 ARMODAFINIL TABLETS50 MG150 MG250 MG MYLAN PHARMACEUTICALS, INC. NUVIGIL TABLETS 6/1/2012 2 ADAPALENE GEL,0.3% TOLMAR INC. DIFFERIN GEL, 0.3% 6/14/2012 3 ABACAVIR TABLETS USP,300 MG

BDR Pharma filed compulsory licensing for BMS's Sprycel (Dasatinib) in Indian Patent Office

Natco Pharma's success in getting the country's first compulsory licence approval on exorbitantly-priced cancer drug-Nexavar-has paved the way for another generic company to follow suit. Little-known BDR Pharma has now filed an application with the M

Medical Council of India asks doctors to prescribe drugs with generic names

India going generic - The Medical Council of India (MCI) has advised deans of all medical colleges to prescribe generic drugs on 7th of May, 2013.The MCI has issued circulars to deans of all medical colleges, directors of post graduate institutes and

ANDA approval of Singulair sets to boost Indian companies Aurobindo Pharma, Glenmark Generics and Torrent Pharmaceuticals.

The U.S. Food and Drug Administration today approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. Montelukast i

Natco, Mylan to appeal against New York district court verdict

India's Natco Pharma and USA's Mylan are considering to appeal against the judgement by a district court in New York that dealt the two companies a severe blow denying them permission to make a me-too version of generic giant Teva Pharmaceutical's Co

Case study on Takeda's acquisition of Inviragen, Inc.

Takeda Pharmaceutical Company Limited (“Takeda”) and Inviragen, Inc. (“Inviragen”) jointly announced today that Takeda, its wholly owned subsidiary Takeda America Holdings, Inc., and Inviragen, Inc. have entered into a definitive agreement for Takeda

Abbott to Acquire Action Pharma's Investigational Compound, AP214, in Phase 2b Development for Prevention of Acute Kidney Injury

Abbott and Action Pharma A/S, a privately owned company, today announced that they have entered into an agreement in which Abbott will acquire AP214 from Action Pharma. AP214 is in development to prevent acute kidney injury (AKI) associated with maj

Ten pharmaceutical companies unite to accelerate development of new medicines

Ten leading biopharmaceutical companies have formed a non-profit organization to accelerate the development of new medicines. Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson Johnson, P

WHO approves India's vaccine regulatory system

In a major relief to vaccine industry, the World Health Organization has approved India's vaccine regulatory system for maintaining international standards. This step opens the way for easy export of vaccines produced in the country.The WHO team of i

Hospira to Acquire Active Pharmaceutical Ingredient Manufacturing and R&D Facilities

Hospira INC, the world's leading provider of injectable drugs and infusion technologies, today announced an agreement for Hospira to acquire an active pharmaceutical ingredient (API) manufacturing facility, together with an associated research and de

FDA approved the first generic versions of Boniva (ibandronate) tablets

The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause. The most common type of bone disease, osteoporosis, is

Pfizer files infringement suit against 6 pharma firms on USPTO's reissue of patent for Celebrex

The United States Patent Trademark Office (USPTO) has granted Pfizer a reissue patent (US Patent No. RE44048), covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex. The reissue p

Wyeth claims $960 mn from Sun Pharma in Protonix case

Wyeth claims $960 mn from Sun Pharma in Protonix case Wyeth PharmaceuticalsInc is seeking $960 million in damages fromSun Pharmaceutical Industriesfor alleged patent infringement in launching a generic version of acid reflux drugProtonixin the United

USFDA approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy

The U.S. Food and Drug Administration approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder. Gaucher disease occurs in people who do not produce enough of an enzyme

Ranbaxy Laboratories launches cholesterol reducing drug in 3 European countries

Ranbaxy Laboratories launches cholesterol reducing drug in 3 European countriesRanbaxy Laboratories, has announced launched generic versions of Atorvastatin tablets, used for the treatment of cholesterol, in three European countries Italy, Sweden and

Statistics on Orphan drug product Designations at USFDA and list of Orphan Diseases as per US Department of Health

Encouraging start to the year for Bayer

Sales of the Bayer Group advanced by 6.8 percent in the first quarter, to a record EUR 10,056 million (Q1 2011: EUR 9,415 million). Adjusted for currency and portfolio effects, business expanded by 5.2 percent. The operating result (EBIT) climbed

US FDA approves labelling update for Merck's Isentress

The US Food and Drug Administration (FDA) has approved a labelling update for Merck's, known as MSD outside the United States and Canada, Isentress (raltegravir) film-coated tablets to include 156-week data from the STARTMRK study with Isentress in c

Bayer HealthCare and Beijing's Tsinghua University extend innovative drug discovery partnership

Bayer HealthCare Company Ltd and Tsinghua University in Beijing, China, are expanding their joint research partnership relating to the Bayer-Tsinghua Joint Research Center for Innovative Drug Discovery (BTC). both partners Both partner signed a new

Covidien entered into an agreement with Xanodyne Pharmaceuticals to purchase Roxicodone®

Mallinckrodt, the Pharmaceuticals business of Covidien (NYSE: COV), today announced that it has entered into an agreement with Xanodyne Pharmaceuticals to purchase Roxicodone® (oxycodone hydrochloride tablets USP) in 5, 15 and 30 mg dosage strengths.

Natco lost a patent litigation against Teva in the US over multiple sclerosis treatment drug, Copaxone.

Natco Pharma Ltd has lost a patent litigation against Israel's Teva Pharmaceutical Industries Ltd in the US over multiple sclerosis treatment drug, Copaxone. The US District Court of Southern District of New York has upheld the contention of Teva P

Novo Nordisk and Oxford University team up to develop novel treatments

Novo Nordisk and the Kennedy Institute of Rheumatology at Oxford University jointly announced a new partnership to develop promising new drug candidates and identify novel biomarkers and treatment targets for rheumatoid arthritis and other autoimm

Increase health care allocation to 2.5% of GDP: Dr Reddy's

At least 2.5 per cent of the country's GDP in the forthcoming Budget should be allocated on improving health care, says Dr Reddy's Laboratories, India's second largest drug maker."Time has now come to incentivise and encourage the penetration of heal

Dr. Reddy's Laboratories Ltd. And Merck Serono Announce Collaboration To Develop And Commercialize Biosimilars (Press Release)

Dr. Reddy’s Laboratories Ltd. [NYSE:RDY] and Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs). T

AstraZeneca launches heart drug Brilinta in India

AstraZeneca Pharma India today launched its patented antiplatelet drug Brilinta, used to prevent heart attack, after receiving approval from the Drug Controller General of India (DCGI). Based on the New Drug Advisory Committee's (NDAC) recommendatio

International Ayurveda Foundation urges govt to include Ayush streams in NCHRH

International Ayurveda Foundation urges govt to include Ayush streams in NCHRH The International Ayurveda Foundation (IAF) has asked the government to reconsider the National Commission for Human Resources in Health (NCHRH) Bill to include the Ayush

Bayer challenges Nexavar generic licence order

Drugmaker Bayer has filed an appeal against an Indian Patents Office's order , which allowed domestic drug maker Natco Pharma to sell a generic version of the German firm's cancer drug 'Nexavar' in India, with the Intellectual Property Appellate Boar

Hearing on Novartis’ case on Sec 3(d) of India's Patents Act in SC to be delayed

Hearing on Novartis’ case on Sec 3(d) of India's Patents Act in SC to be delayed he hearing on Novartis' case on Section 3(d) of India's Patents Act in Supreme Court is likely be delayed from 28 February to sometime in March as the Mumbai terror atta

Epiduo Gel Becomes First Topical Prescription Acne Treatment Available For Children As Young As 9 Years Old

"Pediatricians and dermatologists are seeing a steady increase in children reaching puberty at an earlier age and, consequently, many children are dealing with acne sooner than traditionally observed ​U.S. Food and Drug Administration (FDA) has appro

FDA announces safety changes in labeling for some cholesterol-lowering drugs

Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration. These products, when used with diet and exercise, help to lower a person's

Novartis made Strong sales performance in pharmaceuticals and Alcon

Novartis net sales declined by 2% (-1% cc) to USD 13.7 billion. Currency negatively impacted sales by 1% due to the strengthening of the dollar against many currencies. Products launched since 2007 drove the Group to strong volume growth of 5 perc

US FDA approves Watson Pharma's lidocaine topical patch 5%

The United States Food and Drug Administration (FDA) has granted final approval to Watson Pharmaceuticals' Abbreviated New Drug Application (ANDA) for lidocaine topical patch five per cent, the generic equivalent to Endo's Lidoderm. Watson plans to

Novartis halts hepatitis drug trial after death

Swiss pharmaceutical company Novartis AG says it has halted clinical trials for a new drug to treat hepatitis after one patient died. The Basel-based company says it has informed the U.S. Food and Drug Administration of "a small number" of reported

Amgen and AstraZeneca announce collaboration to jointly develop and commercialize clinical-stage inflammation portfolio

Amgen and AstraZeneca Plc, announced an agreement to jointly develop and commercialize five monoclonal antibodies from Amgen's clinical inflammation portfolio (AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab (AMG 827)). The companies believe all t

Daiichi Sankyo and Ranbaxy to expand Hybrid Business Model in Romania

Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) and Ranbaxy Laboratories Limited (“Ranbaxy”) announced today that “Terapia Ranbaxy”, a subsidiary of Ranbaxy in Romania, will launch Sevikar®, a fixed dose combination of olmesartan medoxomil and aml

AstraZeneca and The Medicines Company announce global collaboration in acute ischaemic heart disease

AstraZeneca and The Medicines Company announced a global collaboration for their acute ischaemic heart disease compounds. The first part of this collaboration is a US co-promotion for AstraZeneca's oral antiplatelet medicine BRILINTA. Under the te

Industry needs to adopt self-policing to meet regulatory challenges: Govt officials

Industry needs to adopt self-policing to meet regulatory challenges: Govt officialsAs part of confidence building measure between the industry and the government, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) recently organised a

Marina Biotech, Girindus enter strategic alliance

Marina Biotech, Inc., a leading nucleic acid-based drug discovery and development company, and Girindus Group have entered into a strategic alliance where Girindus will have exclusive rights to develop, supply and commercialize certain oligonucleotid

Govt alarmed as MNC buyouts set to push up drug prices in India

Govt alarmed as MNC buyouts set to push up drug prices in India The price of India-made low-cost generic drugs could be sky high soon. The Union health ministry's internal assessment suggests the recent buy-offs by multinational companies of Indian f

A Well-Balanced Pipeline

Boehringer Ingelheim has a rich pipeline showing a number of new molecular entities and a high share of products in late phase development. The company has brought a range of products from its own research development to market. A number of these dr

China to license copies of patented medicines

New law allows companies to produce generic versions during emergencies, unusual circumstances, or in public interest. ​Chinese intellectual property laws have been overhauled to allow the nation's drug makers to make less expensive copies of medici

AstraZeneca completes acquisition of California-based, Ardea Biosciences

AstraZeneca has completed acquisition of biotechnology company Ardea Biosciences, Inc. The merger was approved by Ardea’s stockholders. Upon completion of the merger, each outstanding share of Ardea common stock was cancelled and converted into the

US FDA committee recommends approval of Lorcaserin

Arena Pharmaceuticals, Inc. and Eisai Inc. have received positive votes the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the p

Watson challenges Testim patent

Watson Laboratories, Inc., a subsidiary of Watson Pharmaceuticals, Inc., has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market testosterone gel, 1%. Watson's 1% testosterone gel

US FDA grants orphan drug status for Coronado's CNDO-109-Activated

Coronado Biosciences Inc., a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, has received orphan-drug designation from US Food and Drug Administration (FDA) for C

USFDA: Original New Drug Application (NDA) Approvals September 2011

Drug Name and FDA Appl. # Active Ingredients NDA Chem. Type* Review Classifi- cation** Company Approval Date PUR-WASH (NDA # 022305) PURIFIED WATER 5 S NIAGARA PHARMA INC 09/01/2011 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE (NDA # 2021

Allena Pharmaceuticals Licenses Worldwide Rights to Hyperoxaluria Portfolio from Althea Technologies

Allena Pharmaceuticals, Inc., a company developing and commercializing innovative non-systemic oral protein therapeutics to treat metabolic and orphan diseases, and Althea Technologies, a leading contract manufacturing organization providing developm

Eisai Amends License Agreement With Teikoku Pharma USA For Aricept® Patch (Donepezil Transdermal System)

Eisai announced today that the company has amended the licensing agreement with Teikoku Pharma USA, Inc. (TPU), a subsidiary of Teikoku Seiyaku Co., Ltd., pertaining to exclusive overseas marketing rights for the Aricept® patch (once weekly donepezil

Generics slash Pfizer's Lipitor sales

Generics slash Pfizer's Lipitor sales Lately, almost every day we've heard of a new Pfizer ($PFE) strategy for hanging on toLipitorsales after the drug faces generic competition. Discounts, co-pay cards, rebates, conversion to OTC--the moves have bee

BMS made a solid first quater growth

Bristol-Myers Squibb Company (NYSE: BMY) announced first quarter results that included double-digit earnings growth and important RD milestones in its metabolics and hepatitis C (HCV) franchises. The Company also confirmed guidance for 2012. "This f

Nimesulide promotional literature, packaging should hav box warning

Takeda acquires URL Pharma for $800 million

Takeda Pharmaceutical Co. subsidiary Takeda America Holdings, Inc. has acquired URL Pharma Inc. for $800 million. The deal also includes an agreement for future performance-based contingent earn out payments. URL Pharma will be managed by Deerfield-b

Biosimilar products development gets a USFDA norms boost

Biosimilar products development gets a USFDA norms boost ​But they form the basis for Indian companies to attack a market that would open up by 2015 and could reach $11 billion by 2020. A biosimilar is a product that is similar to a biologic, which i

Government Decision to continue 100% Foreign Direct Investment (FDI) in Pharma sector

Government Decision to continue 100% Foreign Direct Investment (FDI) Domestic drug makers have welcomed the government’s decision to continue with 100 per cent foreign direct investment (FDI) in the domestic pharmaceutical sector and make the C

Biocon, Mylan in deal for 3 bio-generic insulin drugs

Biocon, a global biopharmaceutical enterprise, has entered into a strategic collaboration with Mylan to develop generic insulin products. As per the agreement, both companies will share development and other costs to bring these products to the marke

US FDA approves Abbott's ARCHITECT AFP test to detect serious birth defects & progression of testicular cancer

The US Food and Drug Administration (FDA) has approved Abbott's ARCHITECT AFP test, which may help doctors detect serious birth defects and the progression of testicular cancer. The new assay runs on Abbott's fully-automated ARCHITECT i2000, i2000SR,

First-Time Generic Drug Approvals - June 2012

Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 ARMODAFINIL TABLETS50 MG150 MG250 MG MYLAN PHARMACEUTICALS, INC. NUVIGIL TABLETS 6/1/2012 2 ADAPALENE GEL,0.3% TOLMAR INC. DIFFERIN GEL, 0.3% 6/14/2012 3 ABACAVIR TABLETS USP,300 MG

From cold to HIV, this drug can fight any viralinfection

From cold to HIV, this drug can fight any viralinfection In what might be the greatest medical discovery since penicillin, scientists have developed a broad-spectrum drug which they claim can cure everything - from the common cold to HIV to almost an

Ranbaxy Laboratories Trie, in preparation for the upcoming U.S. launch of the product through its dermatology sales force

Ranbaxy Laboratories Inc. (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), today announced that the U.S. Food and Drug Administration (FDA) has approved Absoriea™ a novel, patented brand formulation of the acne medication isotr

Pfizer plans direct-to-consumer Lipitor sales

Pfizer plans direct-to-consumer Lipitor sales Lately, almost every day we've heard of a new Pfizer ($PFE) strategy for hanging on toLipitorsales after the drug faces generic competition. Discounts, co-pay cards, rebates, conversion to OTC--the moves

Global drug industry tightens anti-corruption code

Global drug industry tightens anti-corruption code Ben HirschlerThe global pharmaceutical industry is tightening its code of practice in a bid to stamp out bribery and corruption, particularly in emerging markets.The International Federation of Phar

Pfizer Ends Social Media Bid For Trial Recruitment

A closely watched effort to use social media almost exclusively to recruit patients for a clinical trial has come to a disappointing end. One year after launching its so-called clinical-trial-in-a-box, Pfizer is discontinuing enrollment in the first

Direct-to-consumer advertising

Direct-to-consumer advertising (DTC advertising) usually refers to the marketing of pharmaceutical products but can apply in other areas as well. This form of advertising is directed toward patients, rather than healthcare professionals. The Food and

CDSCO plans to set up sophisticated Pharma Research Laboratory at Rs.50 crore

CDSCO plans to set up sophisticated Pharma Research Laboratory atRs.50 crore With many of the central drug laboratories and those in the States are ill-equipped to handle the foreign substances, the Central Drugs Standard Control Organisation (CDSCO)

FDA Finds Serious Problems in Cancer Drug Factory

FDA Finds Serious Problems in Cancer Drug Factory Federal inspectors say the contract manufacturer for Johnson Johnson's cancer drug Doxil hasn't been maintaining equipment or promptly investigating defective product batches and other serious proble

US drugmaker Pfizer scraps insulin deal with Biocon

US drugmaker Pfizer scraps insulin deal with Biocon ​ USdrugmakerPfizersaid on Monday it has scrapped a deal to sellinsulin productsmade byBiocon Ltd, in what is set to be a major blow for India's largest listed biotech firm.The companies did not say

Takeda to Acquire URL Pharma

Takeda America Holdings, Inc. and URL Pharma have entered into a definitive agreement to acquire URL Pharma - a privately-held pharmaceutical company headquartered in Philadelphia, Pennsylvania, for an upfront payment of $800 million and future perfo

UCB marks World Parkinson's Disease Day with new Parkinson's Well-Being Map™

UCB is announcing a new initiative for World Parkinson's Disease Day 2012 that is designed to support communication around all aspects of Parkinson's Disease (PD). The Parkinson's Well-Being Map™ is a visual tool designed to help people with PD discu

Supreme Court begins final stage hearing of Patent case of Novartis

Supreme Court begins final stage hearing of Patent case of Novartis The Supreme Court has started final stage hearing of the controversial case of Novartis that challenges the Section 3(d) of India’s Patents Act. The company is constantly oppos

Top selling drugs going off patent in 2012

Followings are the top seling drugs which are going off patent in the year 2012. Brand Name Generic Name Sales (U.S.) Company % of Revenue (Billions) Plavix Clopidogrel 6.1 Bristol-Myers Squibb (BMY) 48% Seroquel Quetiapine 3.1 AstraZeneca (AZN) 2

MHRA grants marketing authorization for pSivida Iluvien insert

UK-based Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization to pSivida for its Iluvien insert. The marketing authorization follows the recently announced approval in Austria. The approvals were based on the

India’s Supreme Court to Hear Dispute on Drug Patents

India’s Supreme Court to Hear Dispute on Drug Patents While China was becoming the world’s shop floor, India took its place as the world’s pharmacy, and in recent decades has been the largest provider of cheap, lifesaving medicines in poor countries

European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections

European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on insp

Biocon and Pfizer's Insulin deal called off

Biotechnology giant Biocon has called off the deal with global pharma giantPfizerto produce biosimilar versions ofinsulinand insulin analog products stating both firms wanted to concentrate on their "individual priorities for their respective biosimi

Dr. Reddy's Announces the Launch of Ropinirole Hydrochloride XR (Extended-Release) Tablets

Dr. Reddy's Laboratories announced today that it has launched Ropinirole Hydrochloride XR (Extended-Release) tablets (2 mg, 4 mg, 6 mg, 8mg, and 12 mg), a bioequivalent generic version of REQUIP XL (R) tablets in the US market on June 06, 2012 follow

US FDA issues draft guidance on biosimilar product development

US FDA issues draft guidance on biosimilar product developmentThe US Food and Drug Administration (FDA) issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. “Whe

Remove barriers to help exports, India urges Indonesia

Remove barriers to help exports, India urges IndonesiaUnion Minister for Commerce Industry and Textiles Anand Sharma has urged Indonesia to improve its offer on services and remove the non-tariff trade barriers that are discouraging India’s exports o

US FDA finalizing draft rules on data submissions to demonstrate bio-similarity to reference product

US FDA finalizing draft rules on data submissions to demonstrate bio-similarity to reference product US FDA may soon finalize a set of guidelines titled ‘Scientific considerations in demonstrating bio-similarity to Reference Product’. The draft guid

Generic drug major Teva entering India with Joint venture with P&G

Global pharma giant, Teva Pharmaceutical Industries (TPI) shall foray into India through a joint venture with US based Proctor Gamble (PG) and will set up its first manufacturing facility at Sanand in Gujarat, a top state official said here. "TPI

Abbott to Separate in to Two Leading Companies in Diversified Medical Products and Research-Based Pharmaceuticals

Abbott to Separate into Two Leading Companies in Diversified Medical Products and Research-Based PharmaceuticalsAbbott (NYSE: ABT) announced that it plans to separate into two publicly traded companies, one in diversified medical products and the oth

Regulatory issues cost high, Ranbaxy Takes Q4 Loss

Regulatory issues cost high, Ranbaxy Takes Q4 Loss Indian drug manufacturer Ranbaxy Laboratories, still reeling from a $500 million fine paid for regulatory violations, announced on 24 February that it would suffer a $607 million loss despite increas

Strides acquired star drug

Drug firm Strides Arcolab today said its subsidiary Agila Specialities has acquired a US health regulator-approved facility in Tamil Nadu from Star Drugs and Research Labs Ltd for about Rs 125 crore. As part of its well articulated strategy to build

Curry can help cure tennis elbow

Curry can help cure tennis elbow It seems that your grandmother was right — eating curry could cure your tennis elbow by reducing inflammation, says a new study. Researchers have found that a key ingredient found in Indian curries — curcu

Glenmark recalls seven lots of Norgestimate and Ethinyl Estradiol tablets

Glenmark recalls seven lots of Norgestimate and Ethinyl Estradiol tablets Glenmark Generics has announced a consumer-level recall of seven lots of Norgestimate and Ethinyl Estradiol tablets USP, 0.18mg/0.035mg, 0.215mg/0.035mg, 0.25mg/0.035mg, becaus

Sun Pharma gets US FDA nod for generic Astelin nasal spray

Sun Pharmaceutical Industries has received US FDA approval for its subsidiary for generic version of Astelin, Aselastine HCL nasal spray, 0.1 per cent. (137 mcg/spray). This generic azelastine HCL nasal spray is therapeutically equivalent to Astelin

New Strategies in Cardiovascular diseases

New strategies injecting cardiovascular disease (CVD) patients with vaccines and monoclonal antibodies to combat atherosclerosis could soon change the treatment landscape of heart disease. Both approaches, Professor Jan Nilsson told delegates at the

FDA approves new medicine BRILINTA (ticagrelor) for use in the US

DATE : JULY, 2011 AstraZeneca announced that the US Food and Drug Administration (FDA) has approved BRILINTA (ticagrelor) tablets to reduce the rate of heart attack (myocardial infarction [MI]) and cardiovascular (CV) death in adult patients with acu

Astra Zeneca: global, innovation-driven biopharmaceutical business leader

AZ is global, innovation-driven biopharmaceutical business. AZ focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infect

ACE, Lilly Diabetes launch "EmPower Diabetes Emergency Plan" to help people with diabetes prepare for emergencies

The American College of Endocrinology (ACE), the educational and scientific arm of the American Association of Clinical Endocrinologists (AACE), and Lilly Diabetes launched the "EmPower Diabetes Emergency Plan" — a newly designed resource to help peo

Zydus looking to buy Strides' domestic business

There is a market speculation that Ahmedabad-based Zydus Cadila is willing to acquire Bangalore-based Strides Arcolab's Rs 70-crore domestic generic business. Strides' domestic generic business, which has a range of antibiotic and nutraceutical produ

Novartis

Novartis Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic phar

A New Era in Pharmaceutical Innovation Means Major Challenges for the Industry

A New Era in Pharmaceutical Innovation Means Major Challenges for the IndustryThe value generated by a dollar invested in pharmaceutical research and development has fallen by more than 70 percent in recent years, according to a new study from the co

EU sets out tough rules on medicines information

EU sets out tough rules on medicines information PICTURE GALLERY (Reuters) - Europe will strictly limit the amount of information that drug makers can supply to the public on prescription-only medicines and retain a ban on advertising under proposed

India plans to price-control 60% of pharma market

India's government has announced plans to bring at least 400 essential drugs, accounting for 60% of the entire domestic pharma market, under official price control. Currently, the prices of only 34 essential medicines, accounting for around 20%-30% o

US FDA & medical device industry reach agreement in principle on user fees

US FDA medical device industry reach agreement in principle on user fees The U S Food and Drug Administration (FDA) and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third

Lilly launches mobile application for oncology healthcare professionals

Eli Lilly and Company has launched a searchable clinical trial mobile application for oncology healthcare professionals. The app — available for Apple iPad and iPhone, as well as RIM's BlackBerry and Google's Android platforms — allows healthcare

Department of Pharmaceuticals to consider industry feedbacks before finalizing new pricing policy

Department of Pharmaceuticals to consider industry feedbacks before finalizing new pricing policy ​ The new draft of the proposed National Pharmaceutical Pricing Policy (NPPP) has evoked a mixed response as far the official reactions are concerned.

Pfizer voluntarily recalls 28 lots of contraceptive tablets from US market

Pfizer voluntarily recalls 28 lots of contraceptive tablets from US market Pfizer Inc. has voluntarily recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 lots of Norgestrel and Ethinyl Estradiol tablets (generic)for cu

GSK announces submissions for two influenza vaccines

GSK has submitted US and EU regulatory applications seeking approval of a quadrivalent influenza vaccine for the "active immunisation of adults and children from 3 years of age for the prevention of influenza disease caused by influenza virus type

AstraZeneca Buys Gout Drug Maker Ardea

Amid a flurry of MA activity in the biotechnology industry, British drug maker AstraZeneca has agreed a $1.26bn (£781m) deal to buy US firm Ardea Biosciences, which is developing a new drug for patients with gout. Desperate to bolster its threadba

Mylan Launches Generic Version of Epivir® Film Coated Tablets in the UK and Italy, its First Generic ARV Launch in Europe

Mylan Inc. today announced that its UK and Italy-based subsidiaries have launched Lamivudine Film Coated Tablets, 150 mg and 300 mg. This product is the generic version of GlaxoSmithKline's Epivir® Tablets, indicated as part of antiretroviral (ARV) c

Drug price control does not help consum

Drug price control does not help consumer Every time the problem of poor healthcare access in India is discussed and solutions sought, ‘price control' of medicines seems to be an automatic choice for many stakeholders.Conveniently forgotten is the f

Stronger Code of Practice for Global Pharma Industry

Stronger Code of Practice for Global Pharma Industry By Sten StovallDavid Brennan, CEO of AstraZeneca and president of the IFPMA, pictured last year.The world drugs industry is tightening its code of practice in an attempt to clamp down on corruption

Exempt all life saving drugs from GST

Exempt all life saving drugs from GST The Indian Pharmaceutical Industry employs over 4.2 million personnel, both in manufacturing and ancillary sectors. India is ranked 3rd largest country in terms of production volume and 14th in terms of value wit

Amgen to buy Kai Pharmaceuticals to strengthen portfolio of renal segement

Amgeen Inc. agreed to acquire closely held company KAI Pharmaceuticals for $315 million in cash, giving the drug maker rights to an experimental treatment for chronic kidney disease. The deal continues Amgen's strategy of pursuing external transac

Eisai, Minophagen Pharma conclude bexarotene licensing agreement

Eisai Co., Ltd. (Headquarters: Tokyo) and Minophagen Pharmaceutical Co., Ltd. (Headquarters: Tokyo) announced today that they have concluded a license agreement concerning bexarotene (generic name), a treatment for cutaneous T-cell lymphoma (CTCL).

Stay on union health ministry's notification on six drugs (Banned) still valid

Stay of court on union health ministry's notification on six drugs still valid The stay on the notification of the Union Health Ministry for banning the marketing of six controversial drugs is still valid until any verdict comes from the Madras High

Mylan launches HIV-drug Nevirapine in US

Mylan Inc's subsidiary Mylan Pharmaceuticals Inc. has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nevirapine tablets USP, 200 mg. This product is the generic version of Bo

Aurobindo Pharma Limited gets US FDA approval for lamivudine & zidovudine tabs

Aurobindo Pharma Limited, Hyderabad-based pharma major, has received final approval from the US FDA to manufacture and market lamivudine and zidovudine tablets USP 150/300mg (ANDA 202418) and is ready for launch. Lamivudine and zidovudine tablets US

US FDA approves Stiefel's Fabior Foam, 0.1% to treat acne

The US Food and Drug Administration has approved Stiefel's, a GSK company, New Drug Application for Fabior (tazarotene) Foam, 0.1 per cent. It is the only retinoid in a topical foam formulation for the treatment of acne vulgaris in patients 12 years

US FDA approves Perrigo's butoconazole nitrate 2% vaginal cream

Perrigo Company, a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, and APIs, has received final approval from the US Food and Drug Ad

'Gray' Drug Marketer Again Under Scrutiny

'Gray' Drug Marketer Again Under Scrutiny A congressman for a second time is demanding a drug wholesaler answer questions about its handling of one of many lifesaving hospital drugs whose shortages have been disrupting patient care and leading to de

Centre releases 'National Policy on Narcotic Drugs and Psychotropic Substances'

Centre releases 'National Policy on Narcotic Drugs and Psychotropic Substances' The central government has come out with a 'National Policy on Narcotic Drugs and Psychotropic Substances' (NDPS), under which the private sector companies will be allowe

Study Confirms Some Contraceptive Pills More Likely to Cause Blood Clots

Study Confirms Some Contraceptive Pills More Likely to Cause Blood ClotsA study published on bmj.com today confirms previous findings that certain oral contraceptive pills are more likely to cause serious blood clots (venous thromboembolism - VTE ) t

2011 will be a year of regulatory tussle for pharmaceutical industry

2011 will be a year of regulatory tussle for pharmaceutical industry Government policy and regulatory changes were the focus point for thepharmaceutical industryin Indiain the year2011. The government actively intervenedin businessand sought more con

Piramal's entry in healthcare analytics and consulting business with acquisition of Decision Resources Group

The Ajay Piramal-led Piramal Healthcare Ltd has agreed to acquire US-based health information company Decision Resources Group (DRG) for $635 million (Rs. 3,400 crore), marking its entry into the $5.7 billion global healthcare database and consult

Cipla reduces prices of anti-cancer drugs by 75%

Fighting cancer has just become less expensive for millions of Indian patients. More than 12 years after he electrified the pharma industry by taking on powerful global giants in his quest to supply cheap anti-AIDS drugs,CiplapromoterYK Hamiedis back

Aurobindo Pharma receives final approvals for Quetiapine Fumarate Tablets

Aurobindo Pharma Limited is pleased to announce that the company has received final approvals from the US Food Drug Administration (USFDA) to market Quetiapine Fumarate Tablets 25mg, 50mg, 100mg, 150mg, 200mg, 300mg and 400mg (ANDA 091388) Queti

Indian Pharma Export Value: 2002, 2003, 2004, 2005

India's Export of Principal Commodities by Regions DRUGS, PHARMACEUTICALS FINE CHEMICALS S.No Region APR-2002- APR-2003- APR-2004- APR-2005- MAR-2003 MAR-2004 MAR-2005 MAR-2006 Rs. Crores Rs. Crores Rs. Crores Rs. Crores 1 Europe 2858.28 38

US DOJ files consent decree on Ranbaxy

US DOJ files consent decree on Ranbaxy TheUS Department of Justicehas filed a consent decree in the districtcourt of Maryland for the Indian pharmaceutical major, Ranbaxy aiming to resolve the four-year long investigation by the US Food and Drug Adm

Pharma growth slows to single digit in July, 2011

The slowing down of economic growth may be spilling over to the once-resilient pharma sector. After recording a strong double-digit growth consistently month after month, the domestic industry slowed down to a little over 9% in July. Anti-infectives,

Pfizer Announces Top-Line Results of Third Phase 3 Clinical Trial of Tofacitinib (CP-690,550)

Pfizer Announces Top-Line Results of Third Phase 3 Clinical Trial of Tofacitinib (CP-690,550) Pfizer Inc. announced top-line results from the ORAL Scan Phase 3 study (A3921044) of tofacitinib (development code: CP-690,550), formerly known as tasociti

What is the biosimilar molecules approval process?

The European regulatory authorities led with a specially adapted approval procedure to authorize subsequent versions of previously approved biologics, termed "similar biological medicinal products" - often called biosimilars for short. This procedure

US is the high growth market for DRL

The US market is and will remain the largest revenue market for DRL in the next few years. Steady growth in its baseline revenue and upsides from periodically successful Para IV and ‘first-to-file' (FTF) launches in the US buoy up the the company's p

Case on synergy in business model - Daiichi Sankyo and Ranbaxy in Brazil

Daiichi Sankyo Company, Limited and Ranbaxy Laboratories Limited opted synergy in Brazil to expand the business of both companies in the country. As part of this synergy, Ranbaxy will support Daiichi Sankyo's Brazilian subsidiary, Daiichi Sankyo Bras

Biotech's Biggest R & D Spenders in 2011

Biotech's Biggest Spenders 2011If you add up the RD budgets for the top 15 public biotechs in the world, you'll find a tab that runs right about $10 billion. That's not small change, by any means, but to put it in some perspective, it is interesting

DoP to give final shape to the National Pharmaceuticals Pricing Policy within three to four weeks

DoP to give final shape to the National Pharmaceuticals Pricing Policy within three to four weeks Apparently browbeaten by the apex court in the country, the Department of Pharmaceuticals (DoP) has decided to give a final shape to the National Pharma

Ranbaxy near 50% share of atorvastatin market in 6-month exclusivity period

Ranbaxy looks set to garner more than 50% share in the atorvasatatinmarket in the US, overtaking the combined market share of Pfizer's Lipitoras well as its generic partner in the country, during the crucial six-month exclusive marketing period.

Confusion prevails over status of six banned drugs as court is yet to deliver final verdict

Confusion prevails among the state drug authorities and the industry over the status of the union health ministry's notification dated 10/2/2011 in which it had banned six drugs including nimesulide for below 12 years of age and combination of PPA (p

Zydus Cadila has acquired 100% stake in Biochem

Zydus Cadila has acquired 100% stake in BiochemAhmedabad-based pharma major, Zydus Cadila, has acquired 100 per cent stake in Biochem, a Mumbai-based mid-sized drug company. Biochem has presence in therapeutic areas of antibiotics, cardiovascular, an

Battle of Trademark: Accucal Vs. Acical

Sun Pharmaceutical's appeal in a trademark suit seeking injunction against Ahmedabad-based West Coast Pharmaceuticals Ltd has been dismissed by the Gujarat High Court. The decision came after due diligence by the court on various scientific aspects r

NPPA cuts down prices of vitamin C, revises rates of 183 formulation packs

The National Pharmaceutical Pricing Authority (NPPA) has slashed the prices of widely-used bulk drug vitamin C and its derivatives, while raising the price of another bulk drug parachlorometaxylenol (PCMX) and revising the rates of 183 formulation pa

Dr Reddy’s launches Ziprasidone Hydrochloride capsules

Dr Reddy’s Laboratories has launched Ziprasidone Hydrochloride capsules, a bioequivalent generic version of Geodon, in the US market. Geodon is a trademark of Pfizer. Recently, Dr Reddy’s Laboratories received approval by the United States Food an

Pharma cos with huge FCCBs may not get hit as their export earnings remaining high

Pharma cos with huge FCCBs may not get hit as their export earnings remaining high ​ Steady depreciation of Rupee against US Dollar and Euro may not have any major impact on Indian pharmaceutical industry despite many pharma companies have huge expos

Current Indian Pharmaceutical Market

Current Indian pharmaceutical market Amongst the world’s various pharmaceutical markets, Indian pharmaceutical market has emerged as one of the leading and fastest growing markets. As per the information released by Press Information Bureau fr

Rebranding exercise at Aceto Corporation

Aceto Corporation, a global leader in the marketing, sales and distribution of pharmaceutical active ingredients and intermediates, finished dosage form generic pharmaceuticals, nutraceutical products, agricultural protection products and specialty c

Piramal Healthcare Announces the Official Launch of First of its Kind Single-Step Ovulation Detection Kit

Piramal Healthcare Limited launches “i-sure, the first of its kind, single step ovulation detection kit in India. i-sure helps predict the most fertile days of a woman in a month, with 99% accuracy. In today’s hectic lifestyle and busy schedules, c

Augmentin 244 Crs - India's largest selling brand

Widely used drug Augmentin occupied the top slot, becoming the largest selling drug in the overall domestic retail market, while multinational company Abbott leapt to the top position with the largest market share for a 12-month period ending April 2

Natco Pharma bags licence to sell Bayer's cancer drug Nexavar

Natco Pharma bags licence to sell Bayer's cancer drug Nexavar The government has allowed a local drugmaker to make and sell a patented cancer drug at a fraction of the price charged by Germany'sBayerAG, setting a precedent for more such efforts by In

Facts: Indian Pharma Import

IMPORT OF MEDICINAL PHARMA PRODUCTS S.No Countries Apr 2004- Mar 2005 (Rs. crores) April 2005 - Mar-2006 (Rs. crores) 1 China P Rp 908.57 1563.53 2 Switzerland 375.44 547.35 3 U S A 298.11 425.32 4 Germany 188.82 276.33 5 Denmark 107.48 174.48 6 Ita

Ranbaxy resume US export after 4 Year

We recognise that Ranbaxy's most important challenge is finding a resolution to regulatory issues with the US authorities," wrote Joji Nakayama, president chief executive officer, Daiichi Sankyo, in the company's 2011 annual report. Forty-six mont

GSK to pay $3 billion to settle largest ever US drug fraud scandal

GlaxoSmithKline Plc agreed to plead guilty to misdemeanor criminal charges and pay $3 billion to settle what government officials on Monday described as the largest case of healthcare fraud in US history. The agreement, which still needs court appro

Patent office appoints 150 patent examiners to expedite process of patent examinations

Patent office appoints 150 patent examiners to expedite process of patent examinationsTo address the growing pressure from the increasing number of patent applications filed in the country, the Controller General of Patents, Designs and Trademarks re

GSK's strategic planning behind extending the brand image of Crocin

GSK has launched 'Crocin Advance'. The firm claims to disintegrates faster than the standard Paracetamol tablets and also works faster. Crocin's new innovation comes with ‘OptiZorb' disintegration technology with the aim to speed up the procedure rel

Statistics on Bulk Drugs/Formulations-Approved/Imported/Marketed/Registered in India

India pharma cos optimistic of growth despite double dip depression, EU turmoil

India pharma cos optimistic of growth despite double dip depression, EU turmoilIndian pharma sector appears optimistic on its growth prospects during this phase when the second dip economic depression deepens in the US and the financial turmoil in th

Lupin gets US FDA approval for Suprax capsules 400 mg

Lupin, a Rs. 6,950 crore plus pharma major, has received US FDA approval for Suprax (Cefixime) capsules 400 mg. The approval will expand Lupin's range of Suprax dosage forms available to treat the approved indications in appropriate patients. Supr

Daiichi Sankyo & Ranbaxy Announce a New Social Contribution Initiative

Tokyo, Japan and Gurgaon, India (August 31, 2011) — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Ranbaxy Laboratories Limited (hereafter, Ranbaxy) today announced the start of a synergistic initiative to sponsor mobile health

NCK Pharma Solution launches beta version of Pharma Dictionary version 1.2

NCK Pharma Solution Private Limited launches the Pharma Dictionary Version 1.2 ALL IN ONE for Pharmaceutical Professionals, students and educators. The unique is that the dictionary contains the terminologies across the industry from regulatory, prod

EISAI TO LAUNCH INSOMNIA TREATMENT LUNESTA® IN JAPAN

Eisai Co., Ltd. (Headquarters: Tokyo, President CEO: Haruo Naito, “Eisai”) announced today that it will launch the insomnia treatment Lunesta® (eszopiclone) in Japan on April 18. Lunesta, originally discovered and developed by Sunovion Pharmaceut

Pfizer Elects CEO Ian Read as Chairman of the Board

Pfizer Elects CEO Ian Read as Chairman of the Board Pfizer Inc. (NYSE: PFE) announced that its Board of Directors has elected current President and Chief Executive Officer, Ian Read, as Chairman of the Board and Chief Executive Officer, effective im

Teva to invest $7.5 mn in Cocrystal Discovery for novel antiviral therapeutics

Teva Pharmaceutical Industries Ltd. announced that it has signed a collaboration option to license and share purchase agreements to invest in Cocrystal Discovery Inc. (CDI), a biopharmaceutical company focused on the discovery and development of nove

Nutraceutical Company Releases Daily Men’s ED Supplement

Nouveau Life Pharmaceuticals Inc. (Pink Sheets: NOUV), a provider of quality all-natural dietary supplements, reported today that production is complete on the first run of Azul Instant™, an all-natural male enhancement supplement for erectile dysfun

PCI to introduce new regulations for upgrading pharmacy eduction soon

PCI to introduce new regulations for upgrading pharmacy eduction soon With an aim to bring in strategic changes in the way pharmacy education is being imparted in the country, the Pharmacy Council of India (PCI) is soon planning to upgrade and bring

Abbott Japan and Eisai Have Cleared the Condition for Approval of Humira

Abbott Japan Co., Ltd. and Eisai Co., Ltd. announced today that they have received notification from Japan's Ministry of Health, Labour and Welfare (MHLW) that the condition for approval of Humira(R) pre-filled syringe 40 mg/0.8 mL for subcutaneous i

Dr Reddy's Laboratories starts Phase-II trials of 'DRL-17822' molecule in Europe

Dr Reddy's Laboratories starts Phase-II trials of 'DRL-17822' molecule in Europe Dr Reddy's Laboratories, has announced the commencement of phase-II trails of efficacy and safety check of its 'DRL-17822' molecule in Europe. The molecule is designed t

Prices of medicines remained below general inflation rate, NPPA tells Govt:New Delhi

Prices of medicines remained below general inflation rate, NPPA tells Govt:New Delhi Friday, April 01, 2011, 08:00 Hrs; The National Pharmaceutical Pricing Authority (NPPA) has informed that though the prices ofsome formulations were hiked in the rec

Pharma exports may face challenges from China, Russia

Pharma exports may face challenges from China, Russia China’s massive expansion of its bulk drug industry and Russia’s move to achieve self-sufficiency in the pharmaceuticals sector are likely to pose challenges to the manifold export gro

Pfizer reports first-quarter 2012 results

Pfizer Inc. (NYSE: PFE) today reported financial results for first-quarter 2012. First-quarter 2012 revenues were $15.4 billion, a decrease of 7% compared with $16.5 billion in the year-ago quarter, which reflects an operational decline of $1.0 bill

Patents granted in India and expiring during 2012 - 2020

CDSCO plans to set up eight new central drug testing labs at Rs.320-cr

CDSCO plans to set up eight new central drug testing labs atRs.320-cr With controversies and apprehensions still keep surfacing about the quantum of spurious drugs, the Central Drugs Standard Control Organisation (CDSCO) is planning to set up more ce

Ranbaxy ordered to improve India, US plants

Ranbaxy ordered to improve India, US plants US drug regulators have sought a "ground-breaking" injunction against Ranbaxy Laboratories to force the Indian drug major to correct long-standing violations at four of its manufacturing facilities. The c

India: A Pharmaceutical Superpower by 2020: IPC

India: A Pharmaceutical Superpower by 2020: IPCSubodh Priolkar, President of Indian Pharmaceutical Congress (IPC), talked about the seminar on “Vision 2020: India - The Pharma Power House” in the 63rdIPC conference held in Bangalore from 16th-18thDe

FDA OKs first obesity drug in 13 years

U.S. health regulators approved the first new weight-loss drug in 13 years, allowing Arena Pharmaceuticals Inc to bring its Belviq pill to market as public health advocates push for new solutions to the nation's growing obesity epidemic. The Food an

FDA has approved new trade name - Caprelsa - for AstraZeneca's orphan drug vandetanib

The US Food and Drug Administration (FDA) has approved new trade name - Caprelsa - for AstraZeneca's orphan drug vandetanib. Caprelsa is indicated as a treatment of symptomatic or progressive medullary thyroid cancer in patients suffering from unrese

DCGI to issue guidelines on compensation to clinical trial victims

DCGI to issue guidelines on compensation to clinical trial victims With the increasing incidents of deaths and injuries related to clinical trials coming into the open periodically in the country, the Drugs Controller General of India (DCGI) will soo

USFDA: Abbreviated New Drug Application (ANDA) ApprovalsNovember 2011​

USFDA: Original Abbreviated New Drug Application(ANDA) ApprovalsNovember 2011​ Drug Name and FDA Appl. # Active Ingredients Marketing Status Company Approval Date TRANEXAMIC ACID (ANDA # 091657) TRANEXAMIC ACID Prescription BIONICHE PHARMA 11/0

Dr Reddy's Labs and Fujifilm plan to setup JV for generic drugs in Japan

It’s a picture Dr Reddy’s Laboratories surely didn’t imagine when wishing for an entry into Japan, the world’s second-biggest market (after US)for drugs with annual sales of $97 billion. That long-standing desire, however, has

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S strategic Agreement to Deliver Innovative Medicines with Focus on Psychiatric Disorders Worldwide

Starting with a USD 1.8 billion agreement to co-develop and co-commercialize aripiprazole depot formulation and OPC-34712, two companies with a rich CNS heritage form one of the largest global alliances to focus on delivering up to five innovative p

USDFDA: Abbreviated New Drug Application (ANDA) Approvals December 2011

USDFDA: Abbreviated New Drug Application (ANDA) Approvals December 2011 ​ Drug Name and FDA Appl. # Active Ingredients Marketing Status Company Approval Date METHYLPHENIDATE HYDROCHLORIDE (ANDA # 078458) METHYLPHENIDATE HYDROCHLORIDE Prescriptio

Himalaya Drug enters into nutraceutical market with 'HiOwna-Jr' for kids via prescription route

Himalaya Drug Company, the Bangalore-based Rs 1,200 crore manufacturer of ayurvedic drugs and cosmetics, has forayed into nutraceuticals market with the launch of a prescription-based health supplement for kids. “Based on our research with about 1,00

What is biosmilar drugs?

Biosimilars or follow-on biologics are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Biosimilars ar

Novartis receives FDA approval for Arcapta(TM) Neohaler(TM)

July, 2011 Novartis announced that the US Food and Drug Administration (FDA) has approved once-daily Arcapta(TM) Neohaler(TM) (indacaterol inhalation powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in pa

Domestic pharma companies may get hit by DPCO

Domestic pharma companies may get hit by DPCO A recent report released by Fitch Ratings has predicted that 2012 will remain stable for the Indian pharmaceutical sector. However, there are hitches in the growth which has been clearly observed in the t

Abbott is India's largest drugmaker

American firm Abbott Laboratories consolidated its top position in the Indian drug retail market by growing at a faster than its closest competitors. According to the IMS Health Information and Consulting Services data, Abbott's market share for th

Pfizer to lose crown to Sanofi as world’s biggest drug maker

Pfizer to lose crown to Sanofi as world’s biggest drug makerAfter nine years as the world’s biggest maker of medicines,Pfizeris set to cede its crown next year to a company that a decade ago few would have predicted to be leading the pharma league ta

APP Pharma acquires benztropine mesylate, levetiracetam & tranexamic acid injectables from Nexus Pharma

APP Pharmaceuticals, LLC, a Fresenius Kabi Company, has acquired benztropine mesylate injection, levetiracetam injection and tranexamic acid injection from Nexus Pharmaceuticals, Inc. Under terms of the agreement APP takes complete ownership of these

Actos -Takeda's antidiabetic brand patent expiry

The patent on the type 2 diabetes medication from Japan's Takeda, which was launched in 1999, already expired in January. But Takeda came to an agreement with generic drugmakers Ranbaxy, Watson and Mylan under which they won't start marketing Actos u

India to be among top 10 pharma markets by 2015: Ernst & Young report

India to be among top 10 pharma markets by 2015: Ernst Young report Emerging markets India and China will figure in the top 10 pharma markets of the world by 2015, an Ernst Youngreporthas said. The report has identified India as the preferred choi

Indian Pharma sector growth may slow down to 13% in 2011

Indian Pharma sector growth may slow down to 13% in 2011 The Indian pharma industry is expected to register subdued growth of 12-13% in 2011 due to weak macro factors and increasing competition from unlisted players and MNC pharma companies, an indus

Industry asks govt to hold back implementation of bar coding on secondary level packaging

Industry asks govt to defer implementation of bar coding on secondary level packaging Even as the second phase of bar code implementation expected to become effective from January 1, 2012 under which bar coding on secondary level packaging of pharma

Push Strategy making rurual pharma growth doubling

Pharma companies have seen growth rate of their rural market sales doubling on the back of aggressive marketing initiatives. Improved access to healthcare and rising incomes have seen a stronger perk-up in the underserved rural market over the past y

Ranbaxy gets approval to launch generic Lipitor in US

Ranbaxy gets approval to launch generic Lipitor in US ​ Global drug major Ranbaxy Laboratories on Thursday announced the launch of its generic version of its much sought after cholesterol-lowering drug Lipitor in the U.S. market.The announcement of

Linagliptin Receives Approval in Europe for the Treatment of Type 2 Diabetes

Boehringer Ingelheim and Eli Lilly and Company received Marketing Authorization from the European Commission for linagliptin 5 mg film-coated tablets (to be marketed under the trade name Trajenta® in Europe) for the treatment of adults with type

IPC 2011: The 63rd IPC Scientific Session to have 12 Symposia, 71 speakers

The 63rd IPC Scientific Session to have 12 Symposia, 71 speakers The 63rd Indian Pharmaceutical Congress (IPC) 2011 to be held in Bangalore from December 16 to 18, 2011 will have a power packed Scientific Session spanning three days. With the phar

Negative factors, economic slowdown seriously retard growth of Indian pharma: Dr MD Nair

Negative factors, economic slowdown seriously retard growth of Indian pharma: Dr MD NairEconomic downturn, reduced investments, high costs of RD and low productivity, patent cliffs, pressure on drug prices, poor image of the industry and stricter reg

FDA Approved Drugs July 2011

FDA Approved Drug List July 2011 Drug Name and FDA Appl. Suppl Active Ingredients Company Approval Type Approval Date KEMADRIN (NDA # 009818) 018 PROCYCLIDINE HYDROCHLORIDE MONARCH PHARMS Labelling Revision 07/01/2011 INFASURF PRESERVATIVE F

Four potential blockbusters in the Pharma pipeline: Bayer Pharmaceutical

Four potential blockbusters in the Pharma pipeline: Bayer Pharmaceutical ​The Bayer Group plans to continue investing heavily in research and development and expects its Pharmaceuticals business in particular to generate substantial sales with the ne

USFDA: Original New Drug Application (NDA and BLA) Approvals November 2011

USFDA: Original New Drug Application (NDA and BLA) Approvals November 2011 ​ Drug Name and FDA Appl. # Active Ingredients NDA Chem. Type* Review Classifi- cation** Company Approval Date XARELTO (NDA # 202439) RIVAROXABAN S JANSSEN PHARMA 11/

Aegerion Lomitapide drug found to treat hypercholesterolemia

Aegerion Lomitapide drug found to treat hypercholesterolemiaAegerion Pharmaceuticals has reported positive Phase III clinical study results of its Lomitapide drug, used to treat patient with homozygous familial hypercholesterolemia (HoFH).Lomitapide

Elder Pharma launches Zalain in association with Ferrer

Elder Pharmaceuticals Ltd, in association with the Spain based International Pharmaceutical company Ferrer announced the introduction of the Zalain (Sertaconazole), a topical treatment used to treat fungal skin infections for the first time in India.

Bayer seeks US FDA approval for regorafenib to treat metastatic colorectal cancer

Bayer HealthCare,, the US-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the oral multi-kinase inhibitor r

Emami to revive over-the-counter products like Zandu Pancharishta, Nityam Churna

Consumer products maker Emami is reviving its over-the-counter healthcare business with a slew of brand relaunches along with new distribution system, packaging and marketing blitz. "The focus on the OTCportfolio is part of a consolidation exerci

U.S. Nutraceutical Market Predicted to Generate 8% CAGR Through 2015

U.S. Nutraceutical Market Predicted to Generate 8% CAGR Through 2015 The world nutraceutical market is expected to reach more than $180 billion in 2017 due to the aging population, increased prevalence of serious diseases, and an enhanced focus on pr

NCK Pharma Solution Private Limited pharma training courses got Accredition by International Association of Distance Learning

"NCK Pharma Solution Pvt Ltd." now earned Accredited Membership status from INTERNATIONAL ASSOCIATION FOR DISTANCE LEARNING for its Advance Diploma and Certificate course. NCK Pharma Solution Private Limitedhas created a iconic training brand "Knowl

Top 200 pharma brands of 2010 by revenue

Ranks Drug Current Manufacturer Total Sales ($000) % Change 2009 1 Nexium AstraZeneca Pharmaceuticals 52,76,153 4.90% 2 Lipitor Pfizer Inc 52,72,576 -2.30% 3 Plavix Bristol-Myers Squibb Company 46,75,483 10.20% 4 Advair Diskus GlaxoSmithKline 36,55,

USFDA: New Drug Application (NDA and BLA) Approvals December 2011

USFDA: New Drug Application (NDA and BLA) Approvals December 2011 ​ Drug Name and FDA Appl. # Active Ingredients NDA Chem. Type* Review Classifi- cation** Company Approval Date HYDROMORPHONE HYDROCHLORIDE (NDA # 200403) HYDROMORPHONE HYDROCHL

Counterfeit (Fake) drugs & new technology to identify It in India

Counterfeit (Fake) drugs new technology to identify It in India Making pills that could save lives both in India and abroad, Indian pharmaceutical companies are growing faster than ever before. Worth over $12bn, the Indian Pharma industry is expecte

New job opportunities emerging in Big Pharma

New job opportunities emerging in Big Pharma Since 2001, 300,000 pharma employees have lost their jobs, primarily in RD and sales. That's according to Clifford Mintz, the founder of BioInsights, which develops and offers bioscience education and trai

Band-Aid: Classic Brand Success

Band-Aid can be considered as an classic case of branding success. The brand which is almost 86 year old has become generic to the category. Band-Aid is an Adhesive Bandage used to cover minor cuts and bruises. The brand has come a long way to become

Top 200 Pharma Brands by Units of 2010

Sl Drug Current Manufacturer Total Rxs (000) % Change 2009 1 Lipitor Pfizer Inc 37,523 -11.30% 2 Nexium AstraZeneca Pharmaceuticals 25,872 -1.70% 3 Plavix Bristol-Myers Squibb Company 25,000 -2.10% 4 Singulair Merck Co., Inc. 24,666 -0.50% 5 Lexap

List of new drugs approved by the USFDA in the year 2012 tilldate

Drug Name Active Ingredient Date What it’s used for Elelyso taliglucerase alfa 5/1/12 For long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder Stendra avanafil 4/27/12 To treat erectile dysfunction. Amyv

USFDA: New Drug Application (NDA) & Abbreviated New Drug Application ANDA Approvals September 2011

USFDA: New Drug Application (NDA) Approval Drug Name and FDA Appl. # Active Ingredients NDA Chem. Type* Review Classifi- cation** Company Approval Date PUR-WASH (NDA # 022305) PURIFIED WATER 5 S NIAGARA PHARMA INC 09/01/2011 LAMIVUDINE; TENOFOVIR D

USFDA: List of New Drug Approval form Sept 27- October 7

October 7, 2011 Atrovent HFA(ipratropium bromide) Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Approval Cialis(tadalafil) Tablets, Eli Lilly and Co., New or Modified Indication CladribineInjection, Onco Therapies Limited, Approval Fluoxe

Reckitt Benckiser Pharmaceuticals Inc. Announces FDA Approval of Two New Dosage Strengths of Suboxone® Sublingual Film (C-III) for Maintenance Treatment of Opioid Dependence

Reckitt Benckiser Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration (FDA) approval of the 4 mg and 12 mg doses of Suboxone® (buprenorphine and naloxone) sublingual film. Suboxone® sublingual film is indicated for maintenance

Vanderbilt University and Bristol-Myers Squibb sign collaboration agreement to develop novel treatments for parkinson's Disease

Vanderbilt University and Bristol-Myers Squibb Company (NYSE:BMY) have signed a collaboration agreement for the discovery, development and commercialization of novel therapies acting on the mGluR4 glutamate receptor, known as positive allosteric modu

Regulatory Affairs & Clinical Research jobs top biotech's "must-hire" list

Regulatory Affairs Clinical Research jobs top biotech's "must-hire" list Which jobs are the most sought-after in the biotech world? Clinical development and regulatory affairs jobs, according to two biotech staffing experts: Victor Kleinman, executi

Controversy on Section 3(d) Of The Indian Patents Act, 1970

Scope, Implications Of Section 3(d) Of The Indian Patents Act, 1970 (As Amended) Under Indian patent law, there are certain inventions which are deemed specifically not patentable. These are identified in Section 3, and the sub-clause of that sectio

Top 25 brands of India

This is 2010 data. There may be change in positions of the bands best on the performance 2011, 12​

64th Indian Pharmaceutical Congress venue has been shifted from Goa to Chennai

The 64th edition of the Indian Pharmaceutical Congress venue has been shifted from Goa to Chennai. The event will commence from December 6-9, 2012. The four-day event this year will be organized by the Association of Pharmacy Teachers of India (APTI)

Prscription to OTC switch - Marketing Strategy

As a general rule, over-the-counter drugs have to be used primarily to treat a condition that does not require the direct supervision of a doctor and must be proven to be reasonably safe and well-tolerated. OTC drugs are usually also required to have

TOP 10 Blockbuster drugs patent expiry

With patents on many blockbuster drugs about to expire, an estimated $250 billion in sales are at risk between now and 2015. Once drugs lose patent protection, lower-price generics quickly siphon off as much as 90% of their sales. In 2010, the p

Ranking of Pharmaceutical Companies

REVENUESPROFITS RankCompanyGlobal500 rank$ millions% change from 2007$ millions% change from 2007 1 Johnson Johnson 103 63,747 4.3 12,949 22.4 2 Pfizer 152 48,296 -0.3 8,104 -0.5 3 GlaxoSmithKline 168 44,654 -1.7 8,439 -19.1 4 Roche Group 171 44,

Counterfeit Drugs: Definition, Factors Encouraging and Measures to Combat Counterfeiting

Definition: Counterfeit Drugs What is a counterfeit drug? In accordance with Black's law dictionary,' the term "counterfeit drug" may be used to describe а drug made by someone other than the genuine manufacturer, by copying or imitating an original

Brief introduction to career in Pharma Regulatory affairs

Introduction to Regulatory Affairs Understand the importance of regulatory affairs and what happens within the regulatory departments and authorities - and why. Regulatory Affairs (RA) is an upcoming profession within the biomedical / health produc

Revital - Ranbaxy's Classic OTC brand success

Revital is a comprehensive daily food supplement that has a balanced combinationof vitamins, minerals and ginseng. Ginseng is a herbal extract, commonly used toadded energy and well being. Revital’s balanced combination rejuvenates andstrengthens b

TOP 20 Pharmaceutical companies - The Access to Medicine Index 2012 published ranking

GlaxoSmithKline remains top of the leaguetable, but its lead is shrinking, with twonewcomers moving into the top threeclosely behind and more companies joiningthe ranks of the leaders. The industry as awhole is

IPC to add 13 new centres under Pharmacovigilance Programme of India (PVPI) by March 2012

IPC to add 13 new centres under PVPI by March 2012Indian Pharmacopoeia Commission (IPC) which acts as the National Coordinating Centre (NCC) for Pharmacovigilance Programme of India (PvPI) is going to add 13 new Adverse Drug Reaction (ADR) monitoring

Top 10 Pharmaceutical Companies of India

Top 10 Pharmaceuticals in India, as of 2010 Rank Company Revenue 2010 (Rscrore) Revenue 2010 (Rsbillion) 1 Cipla 4,198.96 41.989 2 Ranbaxy 4,162.25 41.622 3 Dr. Reddy's Laboratories 3,763.72 37.637 4 Sun Pharmaceutical 2,463.59 24.635 5 Lupin Ltd 2,

National List of essential Medicine 2011 (NLEM 2011)

National List of essential Medicine 2011 (NLEM 2011) ​ National List of Essential Medicines of India 2011 (NLEM 2011)is a list of medicines, prepared by the Ministry of Health and Family Welfare, which are considered essential in India. The first suc

Current facts of Indian Pharma

Recent Facts of Indian Pharma Industry According to the IMS Health Information and Consulting Services data, Abbott's market share for the year ended May 2011 stood at 6.8%. The company's sales grew 15.1%. Its two closest competitors-Cipla and Ranbax

10 largest U.S. patent losses

In the drug business, exclusivity is everything. Once a branded drug gets generic competition, pricing power fades and sales slowly drain away, leaving drugmakers dependent on the next new thing. It's all very reasonable in theory, but when the drugs

Indian OTC drugs market growing at a rate of 23%

The growth of the Indian over-the-counter or OTC market (that is advertised non-prescription medicines) has outperformed globally. It has been observed that the global OTC market over the past eight years has grown rapidly and is expected to continue

Novartis drug Glivec receives US FDA approval for expanded use in patients with rare gastrointestinal cancer

Novartis drug Glivec receives US FDA approval for expanded use in patients with rare gastrointestinal cancer The US Food and Drug Administration (FDA) has approved an update to the Glivec (imatinib) label to recommend 36 months of treatment after su

Facts and figure of Regulatory Affairs industry job in India

Facts and figure of Regulatory Affairs industry job in India: 120 odd pharma companies operating in India is having established regulatory affairs departments. More than 1000 company is having unstructured Regulatory Affairs working. Team size of RA

Top 10 therapeutic segments in India by market value and growth

Top 10 therapeutic segments in India by market value and growth As per the data available from express pharma online 2008, anti-infective has led the market with market size of Rs. 4973.1 crore and this market is the expected to grow 14.0% during FY

No. of Small Scale Pharma Companies: State Wise List in India

Sl. No State / Union Territory No. Of GMP compliant units Under process for GMP compliant Units which are not in a position to comply GMP norms No. Of units closed or licence suspended 1 JK 5 1 24 0 2 Haryana 70 71 89 0 3 Uttarnchal 28 17 1 0 4 Mah

What is the meaning of OTC drugs or OTC formulation?

Over-the-counter (OTC) drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription. In many

Chnage in the venue of IPC, 2012

The 64th edition of the Indian Pharmaceutical Congress venue has been shifted from Goa to Chennai. The event will commence from December 6-9, 2012. The four-day event this year will be organized by the Association of Pharmacy Teachers of India (APTI)

BCG Matrix and its Significance in Product Mix Analysis

BCG Matrix (Boston Consulting Group Matrix) The“BCG matrix”or Portfolio Analysis is a portfolio planning model had been created by Bruce Henderson for theBoston Consulting Groupin 1968 to helpcorporationswith analysing their businessunits

DPCO 2013- 348 essential medicine under price control: its impact in pharma industry

With the notification of the order, the National Pharmaceutical Pricing Policy (NPPP) 2012 comes into effect and all drugs under NLEM, which account for 60 per cent of total domestic pharma market amounting to nearly Rs 29,000 crore, would come under

348 medicines under National List of Essential Medicine under price control

Recent update on348 medicines under National List of Essential Medicine under price control The National Pharmaceutical Pricing Authority (NPPA) notifying revised ceiling prices for a second batch of drugs categorized under the National List of Esse

Latest Articles

Japan's Meiji Seika acquires Medreich
Pfizer considers $100 billion bid for AstraZeneca
Sun Pharma to acquire Ranbaxy in $3.2 billion deal
Torrent is set to acquire Mumbai-based Elder Pharma's entire domestic formulations business for 2000 crores
GSK's strategic planning behind extending the brand image of Crocin
Slow down hits in indian pharma market... rises concern
Novo Nordisk planning launch of Tresiba in India
348 medicines under National List of Essential Medicine under price control
DPCO 2013- 348 essential medicine under price control: its impact in pharma industry
Case study on Takeda's acquisition of Inviragen, Inc.
Case on synergy in business model - Daiichi Sankyo and Ranbaxy in Brazil
Medical Council of India asks doctors to prescribe drugs with generic names
FDA approves Novartis' Simbrinza for glaucoma
Now, an Indian effort to cut childhood vaccine prices
Statistics on Orphan drug product Designations at USFDA and list of Orphan Diseases as per US Department of Health
FDA Approves Sitavig
Arrhythmia drug may increase cancer risk
Otsuka's NDA for Tolvapta Accepted for Review by the FDA
FDA Accepts Merck’s NDA for an Investigational Tablet Formulation of the Antifungal NOXAFIL® (posaconazole)
WHO approves India's vaccine regulatory system
FDA Approves Diclegis for Pregnant Women Experiencing Nausea and Vomiting
Genzyme’s AUBAGIO® Approved in Argentina for the Treatment of Relapsing MS
Bayer's Investigational Riociguat Granted U.S. FDA Priority Review
B-MS/AZ take over UK exenatide sales
Tiny implants signal new way to treat cancer tumours