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  • Drug pricing debate: Fred Hassan

    Fred Hassan, Warburg Pincus, talks drug pricing and how it is playing out in an election year.

  • I'm a 'fan' of Joe's: Fred Hassan

    I think he will find his base at Valeant, says Fred Hassan, Warburg Pincus, talking about Joseph Papa, the newly appointed CEO of Valeant.

  • FDA panel rejects Sarepta drug

    CNBC's Meg Tirrell reports on an FDA advisory committee's vote to decline the sale of an experimental drug to treat Duchenne muscular dystrophy.

  • The vote followed an emotional meeting at a hotel in Hyattsville, Maryland, in which hundreds of patients and their advocates gathered to urge the Food and Drug Administration to approve the drug, Sarepta Therapeutics Inc's eteplirsen, saying their children had benefited from it.

  • VRX vs. PRGO & SRPT vs the FDA

    CNBC's Meg Tirrell looks into Valeant Pharma's appointment of Joseph Papa to CEO, as well as Sarepta's showdown with the FDA over a muscular dystrophy drug.

  • FDA votes on muscular dystrophy drug

    Sarepta Therapeutics's Eteplirsen is in front of the FDA advisory committee today for a vote on whether the drug is effective in treating Duchenne muscular dystrophy, reports CNBC's Meg Tirrell.

  • Panelists on Monday will make their recommendations after taking into account the FDA staff review, Sarepta's analysis, and public commentary. While the FDA is not obligated to follow the panel's advice, it typically does. DMD has no FDA- approved treatments.

  • April 22- U.S. Food and Drug Administration staff on Friday formulated voting questions on Sarepta Therapeutics Inc's muscle wasting drug, ahead of a highly anticipated meeting of independent panel of experts on Monday to review the drug. DMD has no FDA- approved drugs. Pressure has been mounting on the FDA to approve treatments for the progressive, muscle...

  • April 22- The U.S. Food and Drug Administration on Friday proposed a ban on electrical stimulation devices that are used to curb individuals from engaging in self-injurious or aggressive behavior, saying they pose an "unreasonable and substantial" risk to public health. The Judge Rotenberg Educational Center in Canton, Massachusetts is the only facility...

  • April 22- The U.S. Food and Drug Administration on Friday proposed a ban on electrical stimulation devices that are used to curb individuals from engaging in self-injurious or aggressive behavior, saying they pose an "unreasonable and substantial" risk to public health. ESDs administer electrical shocks through electrodes attached to the skin of...

  • April 21- The U.S. Food and Drug Administration has granted GW Pharmaceuticals Plc's experimental cannabis-derived epilepsy drug "orphan" status for a third group of patients affected by a rare form of the disease. Orphan status is granted to drugs aimed at treating rare diseases, giving the developer incentives such as a seven-year marketing exclusivity in...

  • Other agencies which have opened probes against the company include the State Departments of Health in Pennsylvania and Arizona, The Centers for Medicare and Medicaid, and the U.S. Food and Drug Administration. The investigations by the Departments of Health of Pennsylvania and Arizona and the FDA have closed, Theranos said. Earlier, Bloomberg reported the...

  • April 15- The U.S. Food and Drug Administration has rejected Chiasma Inc's experimental drug to treat adults with a type of growth disorder, the company said on Friday. The Food and Drug Administration issued a complete response letter for Mycapssa indicating that the review cycle for the application was complete and that the therapy was not ready for approval...

  • April 15- The U.S. Food and Drug Administration on Friday rejected Chiasma Inc's drug to treat adults with a type of growth disorder. The drug, Mycapssa, was being evaluated in patients with acromegaly, a growth disorder which can result in serious illness and premature death. Chiasma said it was reviewing the FDA communication and would provide an update on...

  • But, instead of reporting the events to the U.S. Food and Drug Administration, within 30 days of discovering them, as required by law, Medtronic hid them, the Star Tribune said. Medtronic officials told the Star Tribune that the database of adverse events was misfiled internally and was reported to the FDA after it was rediscovered more than five years later.

  • *Panel recommends FDA wait for results of ongoing study. *Drug unlikely to get FDA approval- analyst. The panel voted 12-1 against giving the drug an accelerated approval, and recommended the FDA wait for the results from an ongoing late-stage trial that compares the drug's effect to that of chemotherapy.

  • April 12- An independent panel of experts advising the U.S. Food and Drug Administration did not back the accelerated approval of Clovis Oncology Inc's lung cancer drug. The FDA is not obligated to follow the panel's recommendations, but it typically does so. On Friday, FDA scientists raised questions about whether rociletinib was superior to existing...

  • April 12- An independent panel of experts to the U.S. Food and Drug Administration on Tuesday asked Clovis Oncology Inc for more data on its lung cancer drug before making a final decision on the treatment. The drug, rociletinib, is designed to treat a subset of patients with advanced non-small cell lung cancer whose condition has worsened despite treatment.

  • April 8- The U.S. Food and Drug Administration on Friday moved to revoke approval of a drug used to treat certain conditions in pigs because it could leave a cancerous residue that may affect human health. Dave Warner, a spokesman for the Pork Producers Council, which represents the pork industry, said it is reviewing the implications of the FDA move but will let the...

  • A panel of outside advisers to the FDA is scheduled to vote on the drug on Tuesday. The experts will discuss whether the drug's benefits outweigh risks, and vote if data from an ongoing late-stage study should be submitted before FDA makes its decision. FDA staff reviewers on Friday recommended that rociletinib carry a black box warning, the strongest warning...