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FDA staff review raises questions about MannKind diabetes device

WASHINGTON (Reuters) - An initial review of MannKind Corp's experimental inhaled insulin device, Afrezza, by U.S. Food and Drug Administration staff raised multiple questions about its safety and effectiveness in treating diabetes. The reviewers issued their report before a meeting on April 1 of outside advisers to the FDA who will discuss clinical trial data and advise on whether the product should be approved.

FDA panel votes against Novartis drug for acute heart failure

By Toni Clarke (Reuters) - A drug made by Novartis AG to treat acute heart failure should not be approved because there is insufficient evidence it improves symptoms, a panel of advisers to the U.S. Food and Drug Administration concluded on Thursday. The panel's vote was unanimous. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

Baxter International splitting itself into 2 separate businesses

TRENTON, N.J. - Following a rival's lead, Baxter International Inc. said it's planning a breakup into two health care companies as it tries to boost innovation and profitability and reward shareholders. Thursday's news could mark a recent trend as Wall Street banks look for lucrative business and urge giants such as Pfizer Inc. and Johnson

Alimera makes fourth bid for eye treatment approval from FDA

(Reuters) - Alimera Sciences Inc said it has applied a fourth time for U.S. regulatory approval to start selling an eye implant that delivers a drug to treat a form of blindess in diabetes patients. Alimera said it had provided a safety update and responded to questions the U.S. Food and Drug Administration raised in October, when it rejected marketing approval fo the treatment for a third time.

British cost agency to take broader view of drug value

By Ben Hirschler LONDON (Reuters) - British healthcare cost agency NICE is to take a broader view of the value offered by new medicines under proposals that may make it more likely that it will say "yes" to novel drugs in future. Chief Executive Andrew Dillon told Reuters that wider uptake would only occur, however, if pharmaceutical manufacturers kept a tight rein on prices.

GSK links with top labs on 'big data' drug project

By Ben Hirschler LONDON (Reuters) - GlaxoSmithKline is linking with two top bioscience centres on an open-access research project to tap into "big data" generated by gene research, in a move highlighting how drug companies are learning to share. The new public-private Centre for Therapeutic Target Validation (CTTV) is being created by GSK working alongside the Wellcome Trust Sanger Institute and the European Bioinformatics Institute, both of which are based in Cambridge, England.

FDA says 25 drug companies will voluntarily phase out use of antibiotics for animal growth

WASHINGTON - Twenty-five pharmaceutical companies are voluntarily phasing out the use of antibiotics for growth promotion in animals processed for meat, the Food and Drug Administration said Wednesday. Citing a potential threat to public health, the agency in December asked 26 companies to voluntarily stop labeling drugs important for treating human infection as acceptable for use in animal production. The FDA did not name the one company that has not agreed to withdraw or revise its drugs.

India generic drugmakers' woes put new focus on quality over price

By Bill Berkrot (Reuters) - A spate of regulatory warnings for India's generic drug manufacturers will add a new emphasis on the quality of such medicines in an industry long dominated by the ability to deliver treatments as cheaply as possible, analysts say. In the short term, that is expected to benefit larger global competitors, such as Teva Pharmaceutical Industries Ltd, Actavis Plc and Mylan Inc, which will be called upon to supply drugs no longer available from some of their rivals in India, they said.

FDA staff review recommends against Novartis heart failure drug

By Toni Clarke WASHINGTON (Reuters) - A drug to treat acute heart failure made by Novartis AG should not be approved because there is insufficient evidence to show it improves symptoms, according to an initial review by the U.S. Food and Drug Administration. The review, posted on the FDA's website on Tuesday, comes two days ahead of a meeting of outside advisors who will make their own recommendation on whether the drug should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

U.S. lawmakers want Gilead to explain Sovaldi's hefty price

By Bill Berkrot and Deena Beasley (Reuters) - U.S. lawmakers have asked Gilead Sciences Inc to explain the $84,000 price tag of its new hepatitis C drug Sovaldi, which is encountering resistance from health insurers and state Medicaid programs. The news pushed shares of Gilead down as much as 6 percent on Friday and sparked a sell-off among other leading biotech names on concerns they may have a harder time pricing new medicines. Biogen Idec fell 8 percent, Amgen Inc dropped 3 percent and Celgene Corp lost 3.7 percent.
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