We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
PhRMA has filed a lawsuit against HHS, pushing back against a final rule that the trade group contends would penalize drug manufacturers that provide financial assistance to patients. Read More
The U.S. Department of Justice (DOJ) has issued a subpoena to Eli Lilly, seeking documents related to its Branchburg, N.J., manufacturing plant, the site of employee whistleblowing that alleged quality control failures and the editing of certain findings to make them appear less serious. Read More
Belgian officials said the suspension would remain in effect “pending a more detailed benefit-risk analysis” by the European Medicines Agency. Read More
The Biden administration has reinstated the FDA’s Unapproved Drugs Initiative (UDI) that was shelved late last year in an HHS notice now being described as “legally and factually inaccurate.” Read More
The UK’s Competition and Markets Authority (CMA) is looking into whether AstraZeneca’s proposed $39 billion buyout of Boston, Mass.-based Alexion Pharmaceuticals would stifle competition. Read More
The FDA may decline to review COVID-19 vaccine Emergency Use Authorization (EUA) requests from drugmakers who neglect to meet with the agency during product development, the agency said in a revised guidance released yesterday. Read More
Drug safety surveillance, which saw a massive workload increase at the FDA’s Center for Drug Evaluation and Research (CDER) during the pandemic, hopes to pick up additional funding in the fiscal 2022 budget, said recently appointed center director Patrizia Cavazzoni. Read More
The FDA is still working out details of a regulatory pathway for bispecific antibodies, but the agency has issued a guidance for developers that says, generally, the manufacturing processes should follow “standard monoclonal antibody development practices.” Read More
FDA and industry are going back to the drawing board on proposals for safety labeling updates, according to the latest GDUFA III meetings, which also included discussions on supplement reviews and continued talks on proposals for data and technology modernization, among other topics. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new drugs for approval during its monthly meeting, including Bluebird Bio’s gene therapy for treating early cerebral adrenoleukodystrophy (CALD), a first for the treatment. Read More
In a declaration released Friday following the G20 Global Health Summit in Rome, world leaders called for voluntary patent licensing and technology transfers for COVID-19 vaccines and therapeutics. Read More