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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pharmacogenomics subsections to their prescription drug and biologic product labels when necessary, according to FDA draft guidance released Wednesday.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
A patient advocacy group is using a recently created pathway for challenging generic drugs through the U.S. Patent and Trademark Office to contest the patent on Wyeth’s antibiotic Tygacil outside a Hatch-Waxman ANDA. Read More
Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. Read More
Countries in the Caribbean are working to establish a unified registration process for generic drugs, an effort aimed to improve the quality, availability and access to essential therapies. Read More