Articles in "Pharmaceutical Industry"

AstraZeneca agrees strategic transaction with Almirall in respiratory disease

AstraZeneca today announced that it has entered an agreement to transfer to the company the rights to Almirall's respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch, and sal

Pfizer enters into agreement to acquire Baxter's portfolio of marketed vaccines

Pfizer Inc. has entered into a definitive agreement to acquire Baxter International Inc.'s portfolio of marketed vaccines for $635 million. As part of the transaction, Pfizer will also acquire a portion of Baxter's facility in Orth, Austria, where th

AFREZZA® - A First-in-class Ultra Rapid-Acting Insulin - received USFDA approval

The Food and Drug Administration has approved an inhalable form of insulin to help adults with diabetes control their blood sugar while eating.Recently FDA approved Afrezza, a fast-acting powdered form of insulin that comes in small single-use cartri

Zydus loses 2 popular brands - Dulcolax and Buscopan

Two popular consumer healthcare brands in the domestic market are changing hands. Around 10 years after Ahmedabad-based Zydus Cadila started manufacturing and distributing Dulcolax and Buscopan, these gastro medicines have now been transferred back t

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

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

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

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

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

AstraZeneca selects location for new global R&D centre and corporate headquarters in Cambridge, UK

AstraZeneca today announced that its new UK-based global research and development centre and corporate headquarters will be located at the Cambridge Biomedical Campus on the southern outskirts of the city. By 2016, the new site will house a highly-sk

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

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 grants Bayer’s Stivarga NDA priority review

Bayer HealthCare and Onyx Pharmaceuticals, a biopharmaceutical company based in South San Francisco, announced today that the FDA has granted priority review to the New Drug Application (NDA) for Stivarga (regorafenib) tablets. The NDA for Stivarga i

FDA Panel Gives Nod to Bird Flu Vaccine

An FDA advisory panel has voted in favor of a vaccine against the highly pathogenic H5N1 avian flu that would be stockpiled and used in case of pandemic.By twin votes of 14-0, the panel agreed that the immunogenicity and the safety of the vaccine, ma

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

What is marketing campaign?

Definition: A specific, defined series of activities used in marketing a new or changed product or service, or in using new marketing channels and methods. Effective marketing is often what separates rapidly growing companies from slow-growing or st

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

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

Statin Usage Survey - Its impact and results

Results from the USAGE survey, the largest known cholesterol survey in the U.S. involving more than 10,100 statin users(1), were presented at the American Heart Association's Annual Scientific Sessions, the leading gathering of cardiovascular dise

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

FDA Approves Amgen's XGEVA®

XGEVA Becomes First FDA-Approved Treatment for This Rare DiseaseAmgen(NASDAQ:AMGN) today announced that theU.S. Food and Drug Administration(FDA) has approved a new indication for XGEVA®(denosumab) for the treatment of adults and skeletally mature ad

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

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

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

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 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

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

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

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 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

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

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

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

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

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

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

GSK welcomes the publication of the 2012 Access to Medicines Index

GSK welcomes the publication of the third Access to Medicines (ATM) Index, which measures the performance of the top 20 pharmaceutical companies on their efforts to improve access to medicines and healthcare in developing countries. GSK has been rank

USFDA approves Xeljanz for rheumatoid arthritis

The U.S. Food and Drug Administration today approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.RA is an autoimmune

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

Takeda, Millennium terminate Japanese ganitumab phase III GAMMA study in metastatic pancreatic cancer

Takeda Pharmaceutical Company Limited and Millennium: The Takeda Oncology Company, a subsidiary of Takeda (Millennium), decided to stop the Japanese portion of ganitumab (AMG 479) phase III GAMMA (Gemcitabine and AMG 479 in Metastatic Adenocarcinoma

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

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

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

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

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

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

Eisai to launch anticancer agent Halaven® in Indian market

Eisai Co., Ltd. (Headquarters: Tokyo, President CEO: Haruo Naito, ”Eisai“) announced today that its Indian subsidiary Eisai Pharmaceuticals India Pvt. Ltd. (Mumbai, ”Eisai India“) has launched the anticancer agent Halaven® (eribulin mesylate). Hala

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

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

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

Indian Bio Pharmaceutical Market

The domestic biopharmaceuticals business saw a significant rise in its revenues to $1.3 billion during 2011-12, accounting for 51 percent share of the total revenue. Revenues made from export of biopharmaceuticals were to the tune of $1.2 billion,

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

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

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

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

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

Strides and Lilly enter strategic partnership for branded generic cancer drugs in emerging markets

trides Arcolab Limited and Eli Lilly and Company have announced a collaboration to expand delivery of cancer medicines in the emerging markets.As a part of this arrangement, Lilly will in-license a portfolio of high-quality, branded generic injectabl

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

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

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

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​

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

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

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

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

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

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

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 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

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

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

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

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

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

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.

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

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

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

New Drugs Approved in 2013

Invokana - canagliflozin Used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. Tecfidera - dimethyl fumarate To treat adults with relapsing forms of multiple sclerosis (MS). Dotarem (gadoterate meglumine)For use i

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

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

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

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

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

Echinacea herbal products should not be used in children under 12 years old

The Medicines and Healthcare products Regulatory Agency (MHRA) today advised parents and carers not to use oral herbal products containing Echinacea for children under 12 years of age. Children aged 12 or over and adults can continue to use herbal pr

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

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

Panacea Biotec announces strategic alliance with Kremers Urban

Submission of the first ANDA within this basket of 10 additional products was done in Sep 2012. The remaining 9 ANDAs would be submitted with USFDA over the next 16 months' time period. Panacea Biotec, India's highly progressive research based he

Mylan sues USFDA for permiting Ranbaxy to market Diovan's Generic

Mylan Inc has sued the US drug regulator for not allowing it to market a generic version of the Novartis' hypertension medicine Diovan, saying that Ranbaxy has lost its exclusivity for the drug as it has failed to get the tentative approval to sell t

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

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

Novartis drug Signifor® gains FDA approval as the first medication to treat Cushing's disease, a serious endocrine disorder

As the only pituitary-directed therapy, Signifor represents a novel therapeutic approach by addressing the underlying mechanism of Cushing's disease[1]In the Phase III trial, most patients experienced a sustained decrease in mean urinary-free cortis

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

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

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

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

Statistics on Patent Applications/Granted at Indian Patent Office

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

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

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

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

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

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

Sanofi India launches paracetamol and caffeine combo drug, Combiflam Plus

Sanofi India (previously known as Aventis Pharma), aRs.1,200 crore plus Mumbai-based multinational pharma major, has launched Combiflam Plus, a targeted, fast and effective solution for headaches, which is also gentle on the stomach.Combiflam Plus is

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

Pfizer's phase III trial of Torisel in combo with bevacizumab in RCC fails to meet endpoint

Pfizer Inc. has reported results from phase III INTORACT trial (B1771006), evaluating the combination of bevacizumab plus TORISEL (temsirolimus) compared with bevacizumab plus interferon-alfa-2a (IFN-a-2a) in the first-line treatment of patients with

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

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

Cipla to buy Cipla Medpro to consolidate international business

Cipla, India's second-largest drug firm, has agreed to acquire South Africandrugmaker Cipla Medpro, taking an important step towards consolidating its international business that now makes up more than half its quarterly revenues.Cipla said on Wednes

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

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

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

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

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

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees.Since it was founded in 1885

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

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

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

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

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

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

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

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

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

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

Acuvue : Healthy and Convenient

Brand: Acuvue Company: JohnsonJohnson Acuvue is a major brand in the Rs 60 crore contact lens market. Although the market is led by Bausch and Lomb with around 70% market share, Acuvue can be termed as the innovation leader in this segment. Acuvue,

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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

Margo:lost in the Neem trees !

Brand : Margo Company: Henkel Margo is one of the oldest herbal soaps in India. The brand which is more than 85 years old is famous for its neem content. The product although famous for its positive effects to the skin is nowhere in the market. Th

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

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,

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

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

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

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

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

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

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

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

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

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

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

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

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

NPPA revises prices of 154 formulation packs

The National Pharmaceutical Pricing Authority (NPPA) revised the prices in respect of 154 formulation packs based on bulk drugs including of vitamin C, vitamin E, chlorpromazine, multivitamin, and monocomponent human insulin. As per the notification

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

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

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

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

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

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

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

Pharma exports may grow by 20% this fiscal and touch $12 billion mark: Pharmexcil

Pharma exports may grow by 20% this fiscal and touch $12 billion mark: Pharmexcil Indian Pharma exports is likely to register 17-20 percent growth this fiscal, touching the USD 12 billion mark, a top official of Pharmaceuticals Export Promotion Counc

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

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

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

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

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

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

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Dr. Reddy's and Pfizer settle Lipitor case

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Stronger Code of Practice for Global Pharma Industry

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Exempt all life saving drugs from GST

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

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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).

Drug price control does not help consum

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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

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

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