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Pfizer is calling on the FDA to retroactively assign four-letter suffixes to biologics that act as reference products for innovative biosimilars. Read More
PhRMA will back “responsible” drug patent reforms, but lawmakers would do well to remember how essential patent protections are to getting life-saving medicines to patients, one of the group’s executives told a Senate panel Tuesday. Read More
The designers of a single-payer system “would need to consider whether a substantial reduction in drug prices would reduce manufacturers incentive to develop new drugs,” the report states. Read More
A dispute between Amgen and generics maker Cipla is headed to appellate court after a federal judge turned aside Amgen’s effort to get Cipla to stop making generics of the blockbuster Sensipar while the two companies litigate over rights. Read More
Acacia Pharma’s anti-nausea drug Barhemsys has stalled again, with the FDA issuing a second complete response letter in less than a year over problems at the plant that makes the drug’s main ingredient. Read More
Pharma giant GlaxoSmithKline infringed upon UK-based Vectura’s patent on particle manufacturing and must pay the company $89.7 million, a federal jury in Delaware ruled. Read More
Outgoing FDA Commissioner Scott Gottlieb highlighted plans for drug compounding enforcement among the agency’s drug priorities in his final testimony before House appropriators on April 3. Read More
EU regulators flagged 18 percent of inspected biologics and nine percent of inspected drugs for scientific or regulatory problems in the two decades since European regulators began inspecting drugs and medicines, the European Medicines Agency said in a new report. Read More