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FDAnews welcomes to its new editorial advisory board seven thought leaders with deep experience in the drug, device and clinical research industries. These seven experts are at the top of their field and will help provide our readers with even greater depth and analysis of drug and device industry news and trends. Read More
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