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Glenmark Pharmaceuticals Ltd Says ‍glenmark Pharmaceuticals receives ANDA approval for olmesartan medoxomil tablets, 5 mg, 20 mg and 40 mg?. Olmesartan medoxomil tablets will be manufactured by Glenmark Pharmaceuticals Limited in its manufacturing facility located in GOA.   Source: reuters.com

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Kite receives U.S. Food and Drug Administration priority review for Axicabtagene Ciloleucel. Kite Pharma Inc - Prescription Drug User Fee Act (PDUFA) set for November 29, 2017. Kite Pharma Inc - Biologics License Application submission based on primary analysis of ZUMA-1 Phase 2 trial. Kite Pharma Inc - ‍Expects to…

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Aerie pharmaceuticals reports positive roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% phase 3 topline efficacy results. Aerie pharmaceuticals inc - ‍roclatan™ successfully achieves primary efficacy endpoint in mercury 2 study?. Aerie pharmaceuticals inc - ‍if mercury 1 12-month safety results are also successful, we expect to submit roclatan nda in first half…

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Merck, known as MSD outside the United States and Canada, today announced that it has entered into an exclusive worldwide license agreement with Teijin Pharma for the development, manufacture and commercialization of an investigational preclinical antibody candidate targeting the protein tau. Changes in tau are associated with a number of…

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Johnson & Johnson has agreed to pay $33 million to resolve charges by most U.S. states that it misrepresented the manufacturing practices behind several over-the-counter drugs that were eventually recalled. The settlement, announced by attorneys general for 42 states and the District of Columbia, resolves claims related to several products,…

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Puma Biotechnology Inc's experimental breast cancer drug reduces the risk of disease recurrence and should be approved, an advisory committee to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 12 to 4 in favor of the drug, neratinib, saying its benefits outweighed the risks, though panelists…

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Japan will target a boost in the use of generic drugs to over 80 percent from the current 56 percent by September 2020, two government sources with direct knowledge of the matter said on Tuesday. The move would save Japan hundreds of billions of yen a year, the sources said,…

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Churchill Pharmaceuticals, LLC announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for YONSA™ (abiraterone acetate), an improved ultramicrosize formulation of abiraterone acetate. YONSA is a CYP17 inhibitor for the treatment of metastatic castration-resistant prostate cancer in combination with methylprednisolone. The submission…

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Danish drugmaker Novo Nordisk is looking to expand its obesity business in Latin America on the back of "phenomenal" performance by its new anti-obesity injection Saxenda, a senior company official said on Monday. Novo, the world's largest insulin maker, is betting on obesity to diversify its core diabetes business which…

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The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals and Sanofi's biotech drug for adults with moderate to severe rheumatoid arthritis, the two companies said on Monday. The drug, sarilumab, which will be sold under the brand name Kevzara, will carry a list price of $39,000 per year for the…

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