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Aug. 31, 2012

Vol. 9 No. 172

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Editor's Note

In observance of the Labor Day holiday, FDAnews Drug Daily Bulletin will not be published Monday, Sept. 3. The next issue will be published Tuesday, Sept. 4. Read More

Supreme Court Likely to Keep ‘Safe Harbor’ Broad, Boosting Generic and Biosimilar Makers: Expert

The country’s highest court is likely to mull Hatch-Waxman’s safe-harbor provision now that the U.S. Court of Appeals for the Federal Circuit has issued contradictory rulings on when the law allows drugmakers to use others’ patents without fear of infringement. Read More

Ranbaxy Withdraws 27 Approved ANDAs Under Consent Decree

Ranbaxy has withdrawn its approved ANDAs for 27 U.S. drugs to focus on other applications and fixing good manufacturing practice deviations that prompted a consent decree earlier this year. Read More

FDA Needs Independent Ethics Board to Assess Postmarket Studies

An independent ethics advisory board could help the FDA assess the risks and benefits of approved drugs and firm up its decisionmaking on required postmarket trials, according to a new report that advocates creating such a group. Read More

Abbott’s Humira Approved in Europe for Expanded Treatment of Crohn’s Disease

Abbott Thursday announced that the European Commission (EC) has approved Humira (adalimumab) for the treatment of moderately active Crohn’s disease (CD) in adult patients who have had an inadequate response to conventional therapy. Read More

Cataract Risk for Kids on Vertex’s Cystic Fibrosis Pill: FDA

Children taking Vertex Pharmaceuticals’ cystic fibrosis pill may be at risk of getting cataracts, based on a study in juvenile rats, according to a statement Wednesday on the U.S. Food and Drug Administration’s website. Read More

Genmab Signs Cancer Drug Deal Worth Up to $1.1B

Danish biopharmaceutical company Genmab A/S Thursday said it has granted Janssen Biotech Inc. an exclusive global license to develop and commercialize its Daratumumab treatment for multiple myeloma, a form of cancer found in bone marrow, in a deal that could be worth up to $1.1 billion. Read More

Roche’s Avastin Remains Most Requested Drug in UK’s Cancer Drugs Fund

Almost a quarter of all applications to the UK’s cancer drugs fund between April 2011 and March 2012 were for Roche’s Avastin, according to figures released by the NHS’ National Cancer Action Team (NCAT). Read More

FDA Takes Exelixis Cancer Drug Off Advisory Group Meeting, Approval Date Stays as Nov. 29

Exelixis’ experimental cancer drug cabozantinib has been removed from the agenda of a Food and Drug Administration advisory committee meeting, the company said, but the drug’s potential approval date has not changed. Read More

ArQule Says Partner Halts Cancer Drug Trial, Shares Slide

Biotechnology company ArQule said Japan’s Kyowa Hakko Kirin Co, which holds development rights to an ArQule cancer drug in parts of Asia, suspended patient enrollment in a late-stage trial to treat lung cancer. Read More