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The pharmaceutical industry is becoming more active in sharing clinical trial data in a way that may have seemed inconceivable 20 years ago, drugmakers said, even as it has taken heat for being opaque on disclosures. Read More
The FDA has delayed Clovis Oncology’s bid to approve its new lung cancer treatment, asking for additional trial data that could see the March 30 PDUFA date extended. Read More
The FDA has approved AstraZeneca’s metastatic non-small cell lung cancer drug Tagrisso in a first-of-its-kind indication targeting patients with the EGFR T790M mutation. Read More
It was a big day for Baxalta’s hemophilia franchise on Friday, with the company announcing that it had nabbed marketing authorization in the EU for Obizur, and the FDA giving its approval for Adynovate. Read More
A Merck subsidiary could lose patent protection on the popular antibiotic Cubicin next year, after a federal appellate court invalidated four of the company’s five patents on the drug. Read More
Horizon Pharma shareholders have approved the company’s issuance of more than 81.7 million new shares to help fund the Irish drugmaker’s hostile takeover of Depomed. Read More
Gilead’s Harvoni Wins Expanded Label
The Medicines Company Wins Rehearing In Patent Dispute
Independent Committee Recommends No Changes for Merck Cholesterol Drug Study
Arch Biopartners Wins Orphan Drug Designation for Pseudomonas Aeruginosa Therapy
Roche to Close Four Facilities, Cut 1,200 Jobs Read More