WASHINGTON, D.C., March 21- Senate health Committee Chairman Lamar Alexander today said Congress owes patients and their families a prompt, bipartisan reauthorization of the Food and Drug Administration medical devices and drug user fees agreements, which are set to expire on Sept. 30. Today, we are here to talk about how we continue funding the FD
Senate health Committee Chairman Lamar Alexander today said Congress owes patients and their families a prompt, bipartisan reauthorization of the Food and Drug Administration medical devices and drug user fees agreements, which are set to expire on Sept. 30. Today, we are here to talk about how we continue funding the FDA, the agency responsible fo
Drug firm Glenmark Pharmaceuticals USA today said it has got tentative approval from the United States Food and Drug Administration for Fingolimod capsules. "Glenmark Pharmaceuticals USA has been granted tentative approval by the USFDA for Fingolimod capsules, 0.5 mg, the generic version of Gilenya capsules of Novartis Pharmaceuticals Corp," Glenm
Glenmark Pharmaceuticals Inc., USA has been granted final approval by USFDA for Clobetasol Propionate Ointment USP, 0.05%, the generic version of Temovate Ointment, 0.05% of Fougera Pharmaceuticals Inc. Glenmark Pharmaceuticals Inc., USA has been granted final approval by USFDA for Clobetasol Propionate Ointment USP, 0.05%, the generic version of..
WASHINGTON, DC- The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D., announced a hearing for Tuesday, March 28, 2017, at 10:15 a.m. in room 2123 of the Rayburn House Office Building. The Health Subcommittee recently held a hearing examining the Generic Drug User Fee Amendments and the Biosimilar User Fee Act, both of which also exp
That's why my role as grassroots manager at the American Cancer Society Cancer Action Network is more than just a job for me. In South Carolina, House Bill 3438 will give more patients in our state access to cutting-edge biosimilar medicines while protecting patient safety. H.3438 would enable pharmacists in South Carolina to offer their patients a
Testimony by Janet Woodcock, Director, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD and Peter Marks, Ph.D, Director, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD and Jeffrey E. Shuren, MD, JD, Director, Center for Devices and Radiological Health, Food and D
Ajanta Pharma gained 3.2% in Monday's trade as the company's board of directors approved amalgamation of Gabs Investments with itself. Ajanta Pharma gained 3.2% in Monday's trade as the company's board of directors approved amalgamation of Gabs Investments with itself. Ajanta Pharma on the NSE is currently trading at Rs 1846 per share, and is up by
Dublin- Research and Markets has announced the addition of the "Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry 2017" report to their offering. A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. As patents near expiration, manufactu
Research and Markets has announced the addition of the "Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry 2017" report to their offering. Analyzing the Generic Drugs Sector of the US Pharmaceutical Industry 2017- a comprehensive coverage of the generic drugs market in the United States. Strategies for survival employed by branded
In recent times there has been a growing focus on the generic drugs industry worldwide. Over the years, the global generic drugs industry has grown strongly owing partly to the fact that the period for patent protection has gotten shorter with major blockbuster drugs losing their patent protection. Furthermore, governments around the world have p
These are already approved as a New Drug Application by the FDA, only they are promoted via private label. Pfizer's original branded drug Z-pak was approved by the FDA. Before patent expiry of Z-pak, Pfizer allowed Greenstone to sell Z-pak using authorized generic name Azithromycin Pak.
Erman said Bio Farma plans to sell the biosimilarbiological products derived from living organisms such as tissues, cells, DNA, and proteinsdrug with prices that are more than 50% lower than the biosimilar breast cancer drug produced by European company Roche, which is worth IDR25 million in one dose. "The breast cancer biosimiar drug is patented
EVENT: Health and Human Services Department; Food and Drug Administration holds a workshop on "Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives," focusing on the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. LOCATION: FDA White Oak
Release date- 18032017- Mumbai, Baltimore- Pharma Major Lupin Limited announced today the launch of Mibelas 24 Fe having received an approval from the United States Food and Drug Administration earlier. Lupin's Mibelas 24 Fe is the AB rated generic equivalent of Allergan Pharmaceuticals International Limited's Minastrin 24 Fe Tablets.
By a News Reporter-Staff News Editor at Clinical Trials Week A new study on Digestive System Diseases and Conditions- Inflammatory Bowel Disease is now available. According to news reporting originating in Turin, Italy, by NewsRx journalists, research stated, "Biological therapies represent a fundamental innovation for the management of inflammat
Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) has unveiled the authorized generic version of Minastrin, an oral contraceptive that is combined with progestin/estrogen. This now brings Teva's oral contraceptive portfolio to over 50 ensuring that approximately 50% of prescriptions for oral contraceptives in the United States are a product of
Release date- 18032017- Mumbai, India- Sun Pharmaceutical Industries Ltd was informed by the US FDA yesterday, that it will lift the Import Alert imposed on the Mohali manufacturing facility and remove the facility from the Official Action Initiated status. This proposed action will clear the path for Sun Pharma to supply approved products from the
Release date- 17032017- Maple Grove, MN- Upsher-Smith Laboratories, Inc. today announced that it has entered into an exclusive agreement with an emerging pharmaceutical company to market and distribute three generic products. Under the terms of the agreement, the partner will develop, manufacture and supply the products exclusively for Upsher-Smith
There's nothing more potentially rewarding right now than a visionary biotech company, poised for explosive gains, on the basis of a ground-breaking drug, medical device or procedure. Biotechs worth a look in the markets, include: Cara Therapeutics, Inc., Clovis Oncology, Inc., Biogen Inc., Celgene Corporation, Mylan N.V. amongst others. Amgen is t
There "s nothing more potentially rewarding right now than a visionary biotech company poised for explosive gains on the basis of a ground-breaking drug, medical device or procedure. Large-cap or small-cap, this is the definitive year of biotech, and these five picks are all set for big things in 2017- with momentous catalysts that promise massive
US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. Take AbbVies Humira, for example: over 30 companies are developing a biosimilar version of it, chasing a market worth over $16 bn annually, $10.4 bn of which comes from the US. But in a results earning call this week, Coherus Biosciences CEO Denny Lanf
By a News Reporter-Staff News Editor at Drug Week The Ministry of Health of the Russian Federation has awarded Biocad marketing authorization for its interferon beta-1a biosimilar, a knockoff of Biogen's Rebif that is a key component in treatment of relapsing-remitting multiple sclerosis and included in all international recommendations and...
By a News Reporter-Staff News Editor at Drug Week- Breckenridge Pharmaceutical, Inc. announced the launch of desvenlafaxine succinate extended-release tablets 50 mg and 100 mg, a generic version of Pristiq by Pfizer Inc. The ANDA was filed as a Paragraph IV on the first-to-file date and will share 180- day exclusivity with other ANDA first fil
-New proprietary research by BCC Research predicts that new and innovative antifungal drugs in development, along with a growing number of people with weakened immune systems and FDA fast-track provisions, are aiding growth in the global market for antifungal drugs. "BCC Research predicts that region and North America to account for 24.9% and 36.9