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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
European drugmakers will be allowed to make generics and biosimilars after the European Parliament voted in favor of manufacturing waivers that will allow their export. Read More
The FDA released new draft guidance on recalls—urging drugmakers to prepare written recall procedures to help reduce the time consumers are exposed to defective or potentially harmful products. Read More
A trade group representing combination drug products is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. Read More