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Roche got the greenlight on Thursday to market its blockbuster cancer drug Avastin for the treatment of advanced cervical cancer, making it the first biologic drug approved in combination with chemotherapy for the disease. Read More
Alabama’s Supreme Court Friday reaffirmed its ruling that a brand drugmaker can be held liable for damages caused by a generic version of its product if the generic carries warning labels that are drafted by the brand company. Read More
Amgen is recalling nine lots of its anemia drug Aranesp after a small number of syringes were found to potentially contain cellulose and/or polyester particles. Read More
A U.S. senator is urging the FDA to act on a potential shortage of the antibiotic doxycycline while he mulls legislation that would allow the agency to step in sooner to deal with shortages. Read More
Baxter continues to be plagued with particulate problems, recalling two lots of a dialysis solution and a lot of saline solution that is currently in short supply. Read More
Regulators in Canada are revising the dispute resolution process for drugmakers appealing rulings on drug applications, eliminating some available appeals categories and changing what body is responsible for reviewing the disputes. Read More
Rigel Pharmaceuticals said Wednesday it will not initiate any new studies of R348 for the treatment of dry eye disease, after the compound failed to meet its primary and secondary endpoints in a recently completed Phase II trial. Read More
Endo Pharmaceuticals and Impax Laboratories are facing a second proposed class action lawsuit over an alleged pay-to-delay deal that put off a generic launch of Endo’s pain medication Opana ER. Read More
The FDA’s newly created four-point sliding scale of comparability between original biologic products and their biosimilars does not belong in guidance on data to demonstrate that similarity, PhRMA says. Read More
Drugmakers should add microbiology and pharmacogenomics subsections to their prescription drug and biologic product labels when necessary, according to FDA draft guidance released Wednesday. Read More