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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pharmacogenomics subsections to their prescription drug and biologic product labels when necessary, according to FDA draft guidance released Wednesday.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
Complaints of particulates found in vials of nine lots of Cubist Pharmaceuticals’ anti-infective drug Cubicin prompted the company to initiate its second recall of the drug in as many days. Read More
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than stage by stage, which is the current policy. Read More
To improve ANDA submissions, the FDA should spend more time with generics companies before they file an application, as is done with brand manufacturers in the run-up to an NDA, the Generic Pharmaceutical Association says. Read More
The FDA has given Mapp Biopharmaceutical its blessing to send two additional doses of its experimental ZMapp Ebola monoclonal antibody to Liberia, after agency officials facilitated communication between the drugmaker and Liberian health officials. Read More