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European regulators say there is not enough evidence to conclude that emergency contraceptives lose their effectiveness in women weighing 165 pounds or more, as one manufacturer had cautioned in its product labeling. Read More
A key European advisory panel gave positive opinions for Gilead’s Zydelig and Janssen-Cilag’s Imbruvica to treat various forms of rare blood cancers and a new indication for Allergan’s Ozurdex to treat the eye disorder diabetic macular edema. Read More
The FDA is considering letting branded drugmakers reserve a proprietary name for a new product, with the goal of avoiding potential delays by approving permanent drug names well in advance of product launch. Read More
Baxter is voluntarily recalling four lots of intravenous solutions in response to customer complaints of plastic and fiber particles in the product, its fourth recall this year related to particulates. Read More
The FDA expects to start collecting manufacturing quality metrics data from drugmakers sometime in 2015, a move agency officials say will cost manufacturers little but pay off in the potential for fewer inspections. Read More
Manufacturers looking to speed up drug approvals in the EU and ensure that their products are covered by payers should initiate parallel conversations with the European Medicines Agency and health technology assessment bodies early in the development process, the EMA says. Read More
Compounding pharmacy JCB Laboratories has been hit with an FDA warning letter for failing to properly package and store vials of the powerful anesthetic Propoven. Read More
More than four years after Congress allowed biosimilars, Sandoz said yesterday that the FDA had accepted its application for a biosimilar of Amgen’s Neupogen, a milestone in the race to develop the highly anticipated biological products. Read More
British drug giant GlaxoSmithKline has submitted the world’s first application for approval of a malaria vaccine, a product developed in partnership with the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative. Read More