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Officials from the FDA and the National Institutes of Health, in cooperation with public, private and industry stakeholders, published a framework for defining the levels of evidence needed to support the regulatory qualification of biomarkers for drug development. Read More
The U.S. Supreme Court has refused to hear a case on whether biosimilar makers must wait six months after receiving FDA approval to bring a product to market. Read More
Manufacturers of investigational new drugs intended for research, teaching or chemical analysis do not have to register their establishments with the FDA, according to a revised final rule on the electronic registration of foreign and domestic facilities. Read More
The FDA rejected Vanda Pharmaceuticals petition to delay the approval of ANDAs referencing its schizophrenia therapy Fanapt until its three-year market exclusivity for a new indication expires. Read More
A federal judge awarded the Federal Trade Commission its request to dismiss a pay-for-delay suit that alleges generics drugmaker Watson Laboratories entered an illegal deal with Endo to block the market entry of Opana ER and Lidoderm generics. Read More
The U.S. Supreme Court has paved the way for non-cash patent settlements, which are often reached by branded and generics drugmakers, to trigger antitrust scrutiny after it refused to hear a case involving GlaxoSmithKline’s epilepsy therapy Lamictal. Read More
A federal judge ruled that a generic version of Merck’s Nasonex developed by Teva Pharmaceuticals does not infringe patent claims covering the allergy treatment’s active ingredient. Read More