Of the 21 drugs designed for delivery directly to the female genital tract, only four have a cost-effective, generic equivalent...
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Oncology Biosimilars Market, By Cancer Type, By Product Type, By Distribution Channel, By Geography- Global Industry Insights, Trends, Outlook, and Opportunity Analysis, 2018-2026. Leading generic players such as Mylan N.V., Teva Pharmaceutical Industries Ltd, Allergan Plc, Sandoz are expected to capitalize on these patent expiries and may establis
Albany, NY 01/21/2019 Active Pharmaceutical Ingredients Market- Overview. Biotech/biological APIs have witnessed constant technological evolution, owing to a shift from synthetic chemical APIs to biotech/biological APIs in the global active pharmaceutical ingredients market. Rise in demand for new drugs at a low cost and entry of domestic and
Rockville, MD 01/21/2019 The retinal biosimilars market has witnessed a remarkable boost with the approval of several retinal biosimilars in 2017. Amgen' s Amgevita in March, f Biogen/ Samsung Bioepis's Imraldi in August, and Boehringer Ingelheim Internationl's Cyltezo in November were approved in their respective regions. The International C
Sandoz Canada Inc., a division of Novartis AG, announced today that Health Canada has approved Erelzi, a biosimilar of Enbrel , for the treatment of psoriatic arthritis in adult patients, making Erelzi the only etanercept biosimilar to have obtained approval for this indication in Canada. More specifically, Sandoz Canada Inc. received a Notice of
Slayback Pharma LLC announced today that it has launched its first commercial product Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml. This is the first and only ANDA approved by the FDA for Hydroxyprogesterone Caproate Injection in a multi-dose vial that is therapeutically equivalent to Makena. Hydroxyprogesterone Caproate Injection,
The Center for Biosimilars , an online resource for emerging therapies that focuses on improving patient outcomes, interviewed Michael Kolodziej, M.D., vice president and chief innovation officer at ADVI Health Inc., about what payers will consider when developing strategies around biosimilars. Additionally, Isha Bangia, Pharm.D., M.B.A., added h
Companies that won tender bids for China's pilot program for centralized procurement of generic drugs will be guaranteed a market share of 60-70% when the implementation phase begins in late March. China's State Council approved the program on Thursday and disclosed details of the implementation phase in a program document. In December, China's Joi
NEW DELHI: Drug firm Wockhardt Monday said it has received approval from the US health regulator for generic version of Gleevec used for treatment of cancers and tumours. Wockhardt has received approval from the United States Food& Drug Administration for an abbreviated new drug application for 100 mg and 400 mg tablets of Imatinib Mesylate, the co
The Food and Drug Administration and the Central Ethics Committee in the United States have accepted Xbranes IND application for initiation of the Xplore trial, a phase III trial with Xlucane, a ranibizumab biosimilar candidate. 'It is with great satisfaction we can announce acceptance from the FDA and the Central Ethics Committee to initiate the X
U.S. Senators Amy Klobuchar and Chuck Grassley reintroduced legislation to address the skyrocketing cost of prescription drugs. The bipartisan Preserve Access to Affordable Generics and Biosimilars Act would crack down on anti-competitive pay-for-delay pharmaceutical deals in which branded companies pay their generic competitors not to compete as..
INCHEON, Korea Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration has approved ONTRUZANT , a biosimilar referencing HERCEPTIN 1, across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal juncti
Albany, NY 01/19/2019 Biosimilars are drugs that are highly similar but not identical to branded innovator biologics: large molecule, immunogenic drugs produced from living cells. Innovator biologics are the first to be approved, and when their patent protection expires, biosimilars may be approved, in a similar way to small molecule branded
Pfizer has chosen to drop five biosimilar candidates and 150 jobs to divert the funds into developing its late-stage pipeline. According to a Pfizer spokesperson, the drug candidates were four to eight years away from commercialisation. The decision will also see approximately 150 Pfizer employees within R&D lose their positions.
The FDA approved Teva`s generic for Sabril, the first generic for the drug, as the agency continues to focus its efforts to approve generics that face little competition. The US Food and Drug Administration has expressed its efforts to carve a path for generic drug development, even in the case of limited distribution programs for brand name drugs,
The Food and Drug Administration and the Central Ethics Committee in the United States have accepted Xbranes IND application for initiation of the Xplore trial, a phase III trial with Xlucane, a ranibizumab biosimilar candidate. "It is with great satisfaction we can announce acceptance from the FDA and the Central Ethics Committee to initiate the
New York, NY 01/18/2019 According to the latest market report published by Persistence Market Research, titled' Global ADHD Therapeutics Market: Continuous innovation by drug manufacturers and lucrative marketing strategies to fuel the demand for ADHD Therapeutics during the forecast period', revenue from the global ADHD therapeutics market i
University at Buffalo researchers received an $880,000 grant to help quicken the development of generic equivalents of contraceptives and other drugs delivered vaginally or to the uterus, such as by intrauterine devices. The research, supported by a two-year grant from the U.S. Food and Drug Administration, is led by Robert Bies, PharmD, PhD, assoc
The list price for Lantus, a long-acting insulin made by Sanofi that she injected once a day, had nearly quadrupled over a decade. With Basaglar, I ve never had my insulin cost drop so significantly, said Crook, a legal assistant in Dallas who has Type 1 diabetes. Such agreements make it difficult for generics to compete or know what th
CHINO HILLS, CA/ ACCESSWIRE/ January 18, 2019/ SOHM, Inc., a generic Pharmaceutical, Nutraceutical and Cosmeceutical company that manufactures and markets generic drugs covering numerous treatment categories, announced today some of developments with the company which it started during 2017 and 2018 regarding the outlook of the company for the year
Press release 2019-01-18 The Food and Drug Administration and the Central Ethics Committee in the United States have accepted Xbranes IND application for initiation of the Xplore trial, a phase III trial with Xlucane, a ranibizumab biosimilar candidate. "It is with great satisfaction we can announce acceptance from the FDA and the Central Ethics C
By a News Reporter-Staff News Editor at Pharma Business Week Chinese leading Biopharmaceutical company 3 SBio Inc. announced that it has entered into a collaboration agreement with Samsung Bioepis Co., Ltd. for the clinical development and commercialization of multiple biosimilar candidates developed by Samsung Bioepis, including SB8 Bevacizumab.
By a News Reporter-Staff News Editor at Drug Week Amring Pharmaceuticals Inc., a generic pharmaceutical and ophthalmic medical device company, announced that it launched a generic oncology drug, Arsenic Trioxide Injection in November 2018 and expects to launch four additional generic drugs in 2019. Amring Pharmaceuticals is a privately-held gener
BERHAMPUR: The much-vaunted Niramaya scheme seems to have come a cropper in Ganjam district with doctors at the public health facilities continuing to advise patients to purchase medicines from outside even though they are available free at the hospitals. Chief District Medical Officer Dr Sadananda Mishra has issued show cause notices to two doctor
The Council of the European Union issued the following news release:. The EU has come a step closer to adopting new rules that will boost the export of generic medicines and biosimilar products to third countries. EU ambassadors meeting today in Coreper agreed on the Council's position on a draft regulation which introduces an exception for manufac