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  • UPDATE 1-FDA rejects BioMarin's DMD drug Thursday, 14 Jan 2016 | 8:51 AM ET

    Jan 14- BioMarin Pharmaceutical Inc said on Thursday the U.S. Food and Drug Administration had rejected the company's drug to treat a rare muscle-wasting disorder. The rejection comes after a panel of independent advisers to the FDA indicated that efficacy data on the drug was not persuasive enough for an approval. There is currently no FDA- approved therapy to...

  • FDA rejects BioMarin's muscle-wasting disorder drug Thursday, 14 Jan 2016 | 8:37 AM ET

    Jan 14- BioMarin Pharmaceutical Inc said on Thursday the U.S. Food and Drug Administration had rejected its drug to treat a rare muscle-wasting disorder.

  • Drug pricing is all about balance: CEOs Tuesday, 12 Jan 2016 | 6:10 PM ET
    Leonard Schleifer

    Biotech CEOs say that drug pricing needs to be balanced enough to support research and development.

  • ZURICH, Jan 12- Roche said on Tuesday that the U.S. Food and Drug Administration has granted' priority review' status for its venetoclax drug for the treatment of a blood cancer, which it is developing with partner AbbVie. Roche expects to win FDA approval in the first half of 2016, a spokeswoman at its Basel headquarters said. AbbVie spokesman Carlos Taveras in...

  • ZURICH, Jan 12- Roche said on Tuesday that the U.S. Food and Drug Administration has granted' priority review' status for its venetoclax drug for the treatment of a blood cancer, which it is developing with partner AbbVie. Roche expects to win FDA approval in the first half of 2016, a spokeswoman at its Basel headquarters said. An AbbVie spokesman in Paris said his...

  • ZURICH, Jan 12- Roche said on Tuesday that the U.S. Food and Drug Administration has granted' priority review' status for its venetoclax drug for the treatment of a blood cancer, which it is developing with partner AbbVie. Roche expects to win FDA approval in the first half of 2016, a spokeswoman at its Basel headquarters said. An AbbVie spokesman in Paris said his...

  • ZURICH, Jan 12- Roche said on Tuesday that the U.S. Food and Drug Administration has granted priority review for its venetoclax drug application for blood cancer treatment, which it is developing with partner AbbVie. Brokerage Cowen and Co. has predicted that venetoclax, if approved, could capture annual sales of $2 billion by 2020. Roche is also seeking approval...

  • LONDON, Jan 12- The arrival of cheap generic versions of GlaxoSmithKline's top-selling lung drug Advair has moved a step closer with confirmation from Mylan that it has submitted a generic version for approval. Mylan said late on Monday it had filed an abbreviated new drug application to the U.S. Food and Drug Administration in December. If its product is...

  • In year 6, Obamacare prognosis unclear: Health CEO Sunday, 10 Jan 2016 | 9:00 AM ET
    A man walks out of the UniVista Insurance company office after shopping for a health plan under the Affordable Care Act, on December 15, 2015 in Miami.

    Mount Sinai Hospital's CEO told CNBC that while Obamacare survived a repeal attempt, it's locked in a tough game of numbers.

  • Jan 7- Dynavax Technologies Corp said its experimental hepatitis B vaccine was found to be safe and effective in a late-stage study, paving the way for the company to resubmit its marketing application. The earlier marketing application for the vaccine, HEPLISAV-B, was rejected in February 2013 by the U.S. Food and Drug Administration, which sought additional...

  • Over the past several years, the FDA has received thousands of reports of complications, including bleeding, organ perforation and urinary problems, involving the use of mesh for transvaginal POP repair, the agency said. The FDA noted that an advisory panel of experts in 2011 recommended that more data was needed to establish their safety.

  • FDA approves 45 new drugs in 2015 vs 41 in 2014. LONDON, Jan 4- 2015 was a good year for innovation in medicine with the U.S. Food and Drug Administration approving 45 novel drugs, four more than in 2014 and the most since the all-time record of 53 set in 1996.. Across the Atlantic, the European Medicines Agency recommended 93 new products, including generics, up from 82 in...

  • MUMBAI, Dec 31- India's Cadila Healthcare Ltd said it received a U.S. Food and Drug Administration warning for violating manufacturing standards at two of its production facilities, the latest in a series of Indian firms to face such action. The FDA inspected the Moraiya facility more than a year ago, highlighting a series of issues with manufacturing processes...

  • PARIS, Dec 23- French drugmaker Sanofi said on Wednesday it had submitted an application to the U.S. Food and Drug Administration for a single daily insulin injection to treat adults with type 2 diabetes. Sanofi said it had requested a six-month review of its new drug application by the FDA, rather than the standard 10 months. "A large unmet medical need still exists...

  • FDA probing latest E.coli outbreak linked to Chipotle Tuesday, 22 Dec 2015 | 3:21 PM ET

    The FDA said it is working with the Centers for Disease Control and Prevention and state and local officials. The CDC said on Monday it was investigating five new cases of E.coli infections, one each Kansas and North Dakota and three in Oklahoma. The two who fell ill in North Dakota and Kansas ate at the same restaurant in Kansas, while the three from Oklahoma ate at...

  • Bid to rein in painkiller prescriptions stalls Saturday, 19 Dec 2015 | 6:46 AM ET
    Prescription drugs

    A bold federal effort to curb prescribing of painkillers may be faltering amid stiff resistance.

  • Dec 18- The U.S. Food and Drug Administration on Friday proposed banning people under the age of 18 from using sunbeds and requiring sunbed manufacturers to make warnings clearer. In 2013 the FDA recommended that tanning beds not be used by people under the age of 18 but stopped short of banning them. Its latest proposal brings it in line with recommendations made...

  • *FDA delays deadline as data review is incomplete. On Friday, the company announced the delay from the FDA, saying the federal agency had not yet completed the review of the drug, which is designed to treat rare disorder Duchenne muscular dystrophy. Analysts from Wedbush Securities, Raymond James and Evercore ISI were of the opinion that the lack of an outright...

  • Dec 18- The U.S. Food and Drug Administration on Friday proposed banning people under the age of 18 from using sunbeds and requiring sunbed manufacturers to make sunbed warnings clearer. In 2013 the FDA recommended that tanning beds not be used by people under the age of 18 but stopped short of banning them. Its latest proposal brings it in line with...

  • The FDA was set to decide on the approval by Dec. 27, and the agency anticipates giving its decision in early January, the company said on Friday. BioMarin's DMD drug, to be named Kyndrisa on getting the FDA nod, was expected to be the first treatment for the muscle wastage disorder that affects one in 3,600 newborn boys and causes rapid muscle degeneration.