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Teva Pharmaceuticals has petitioned the U.S. Supreme Court to review federal appeals court rulings ordering that the drugmaker pay $235.5 million in damages to GlaxoSmithKline (GSK) for patent infringement of GSK’s congestive heart failure drug Coreg (carvedilol). Read More
The FDA has deferred action on BeiGene’s Biologics License Application (BLA) for the monoclonal antibody tislelizumab for esophageal cancer, saying the agency has been unable to conduct required inspections in China due to COVID-19-related travel restrictions. Read More
The FDA’s review of proposed instructions for use (IFU) for a new drug, biologic or combination product will focus on accuracy and consistency with the agency-approved prescribing information, according to a final labeling guidance issued yesterday. Read More
Just before their trial wrapped up, Allergan and Teva Pharmaceuticals reached a $54 million settlement agreement with the city of San Francisco over the companies’ role in the opioid crisis there. Read More
Viatris, formerly Mylan, now must pay out a settlement of $264 million to consumers, insurers and pension funds who sued the company over steep price spikes for EpiPen, which is used to quickly administer epinephrine to treat potentially fatal allergic reactions. Read More
Astellas Pharma and two other plaintiffs have filed a patent infringement lawsuit in an effort to stop Zydus Pharmaceuticals from marketing a generic version of the prostate cancer drug Xtandi (enzalutamide). Read More
The FDA would be compelled to finalize a 15-year old proposed rule requiring drugmakers to cease using distracting images and sounds in TV ads under a new bill introduced in the House. Read More
Five months into his tenure as FDA commissioner, Robert Califf warned that the agency’s ability to review medical products would be drastically curtailed if Congress doesn’t pass a user fee reauthorization package by August. Read More
Drugs containing nomegestrol or chlormadinone are typically used for gynecological and menstrual disorders, hormone replacement therapy and, at lower doses, as hormonal contraceptives. Read More