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.
Since the FDA knew the end of the public health emergency was nigh, the agency already had begun working with holders of EUAs to transition them to full approval, Marks said.
An appeals court ruled that Teva “induced infringement” of GSK’s patent by pressing doctors to prescribe its generic version of a cardiac medicine rather than GSK’s brand-name congestive heart failure drug. Read More
The company filed a Freedom of Information Act (FOIA) request asking the FDA to release all of the documents pertaining to its no-go decision. Read More
Global Pharma Healthcare — the Chennai, India-based drugmaker that has issued two recent high-profile recalls of its eye drops for potential contamination — drew an 11-observation Form 483 from the FDA citing lax sterility practices and other deficiencies. Read More
A federal jury has ordered Novartis’ Sandoz subsidiary to pay $39 million in damages to Allergan and Duke University for infringement of patent rights for Allergan’s eyelash-enhancing therapy Latisse (bimatoprost). Read More
A trio of Republicans on the House Energy and Commerce Committee have called on the FDA to explain what steps the agency is taking to address persistent drug shortages and supply chain vulnerabilities. Read More
The U.S. Solicitor General is asking the Supreme Court to consider a case — Teva Pharmaceuticals v. GlaxoSmithKline (GSK) — that highlights the pharmaceutical industry’s ongoing dispute over “skinny labeling.” Read More
After an FDA career that has spanned more than three decades, former FDA Acting Commissioner Janet Woodcock — who now serves as principal deputy commissioner — still plays a significant role in guiding the agency. Read More
The complaint alleges that the deal between the companies says that if the risk reduction in the Nexletol trial was 20 percent or better, Daiichi would pay Esperion $300 million. Read More