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The FDA has permanently barred an Arlington, Va., distributor from doing business in the U.S. after he was convicted of two felonies for selling counterfeit products. Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More
Purdue Pharma has withdrawn its supplemental new drug application for reformulated OxyContin, causing cancelation of an FDA advisory committee meeting to discuss whether postmarket studies of the product’s extended-release tablets show reduced misuse. Read More
Eli Lilly’s lung cancer drug necitumumab improved overall survival when used with two combined chemotherapies, but caused a small uptick in sudden deaths, the FDA says in a preliminary review issued Tuesday. Read More
Allergan will pay $250 million to acquire the worldwide rights to two of Merck’s investigational small molecule oral calcitonin gene-related peptide (CGRP) antagonists for use against migraines. Read More
AstraZeneca and Cephalon have agreed to pay $54 million, plus interest, to settle allegations that they knowingly underpaid quarterly rebates owed to states under the Medicaid program. Read More
After nearly 25 years of trying to reach biologics manufacturer Chembiomed but getting no response, the FDA today revoked the Canadian firm’s license. Read More
The FDA is offering a four-month grace period to retail and hospital pharmacies that do not act as wholesale distributors to electronically exchange drug transaction information. Read More
The FDA is adding plasma fibrinogen as a prognostic biomarker for patient selection in clinical trials involving chronic obstructive pulmonary disease and a high risk of death. Read More
Manufacturers of influenza vaccines may obtain marketing authorization in the EU based on less-than-comprehensive applications if they supplement their filings with clinical trial data after a pandemic is declared, the European Medicines Agency says. Read More
A panel of judges from the Federal Circuit Court of Appeals has ruled that two of The Medicines Company’s patents for its anticlotting drug Angiomax are invalid — a win for Hospira, which is planning a generic version of the treatment. Read More