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Biomarin Pharmaceuticals Inc said the annual price for its drug, which won U.S. approval on Thursday, to treat a rare and fatal type of pediatric brain disease is expected to be $486,000 after mandatory government discounts and rebates. The Food and Drug Administration approved Brineura, an enzyme replacement therapy, for…

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The U.S. Food and Drug Administration said on Thursday it has approved Bayer AG's drug Stivarga to treat liver cancer, the first such approval in nearly a decade. Stivarga is already approved to treat colorectal cancer in patients who have previously been treated with other therapies. Bayer may now also…

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A federal appeals court on Wednesday partially reversed a ruling that required Nestle SA's Galderma Laboratories Inc to pay about $3.5 million for breaching a licensing agreement covering two drug patents held by New York University. The 2nd U.S. Circuit Court of Appeals in New York reversed a lower-court ruling…

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India's antitrust regulator has ordered a probe into Swiss drugmaker Roche for allegedly using anti-competitive practices to restrict cheaper copies of a blockbuster cancer drug from reaching patients. Trastuzumab has been a mainstay of Roche's profit for years and brought in global sales of about $6.7 billion in 2016, but…

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Novartis said on Tuesday it would accelerate its bid to win approval for its experimental multiple sclerosis (MS) drug BAF312 and said it was now targeting patients at an earlier stage of the neurological disease. With BAF312, Basel-based Novartis aims to join its rival Roche in developing a lucrative new…

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Japanese drugmaker Otsuka Pharmaceutical aims to apply for approval of its tuberculosis (TB) drug delamanid in India within three months, a senior company official said, as calls grow for expanded access to the life-saving medicine. India accounts for about a quarter of the world's TB cases and experts say improved…

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Walvax Biotechnology Co Ltd Says its wholly owned subsidiary received goods manufacture practice (GMP) certificate from Yunnan Food and Drug Administration. Certificate issued pneumococcal polysaccharide vaccine manufactured by the unit and the valid period is until April 18, 2022.   Source: reuters.com

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Paratek Pharmaceuticals, Inc., a bio pharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that it has entered into a collaboration with Zai Lab (Shanghai) Co., Ltd., a biopharmaceutical company based in China, to support the development and commercialization of omadacycline for…

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Bristol-Myers Squibb Co said its lead experimental drug for nonalcoholic steatohepatitis, or NASH, significantly reduced liver fat versus placebo, according to data from a mid-stage trial presented at a medical meeting on Saturday. NASH, a progressive fatty liver disease tied to obesity and diabetes, afflicts about 5 percent of the…

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Ghana, Kenya and Malawi will pilot the world's first malaria vaccine from 2018, offering it for babies and children in high-risk areas as part of real-life trials, the World Health Organization said on Monday. The injectable vaccine, called RTS,S or Mosquirix, was developed by British drugmaker GlaxoSmithKline to protect children…

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