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Drugmakers operating in the EU must submit additional information on their authorized products to the European Medicines Agency, starting immediately, and update previously submitted information by year’s end, according to requirements that took effect June 16. Read More
Sponsors of clinical studies in the European Economic Area ending on or after July 21 of this year must post summary results on the EudraCT clinical trials database by the following July, another step in Europe’s move toward greater trial transparency. Read More
Drugmakers planning to market generic and biosimilar products in Brazil should pair up with the branded firms to facilitate the application process, according to an updated rule aimed at speeding generic approvals. Read More
In a blow to AbbVie’s efforts to head off generic competition on its AndroGel 1%, the FDA said Irish drugmaker Perrigo’s testosterone gel product is bioequivalent and interchangeable. 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
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
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
The FDA approved only the second extended-release opioid painkiller to feature abuse-deterrent properties, and hinted that future products that include such technologies could receive faster regulatory reviews. Read More