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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
The FDA has received heavy pushback from industry groups on its revised plan to collect quality metrics data from manufacturers, according to public comments on two volunteer pilots, the Site Visit and Quality Metrics (QM) Feedback programs. Read More
The FDA and the U.S. Patent and Trademark Office (PTO) will be walking the thin line between preserving patents as an incentive for groundbreaking drug developments and limiting them to allow the emergence of cost-effective generic forms of those drugs. Read More