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British health-payment authorities reversed course last week and cleared the way for the use of Astellas Pharma’s advanced prostate cancer drug Xtandi in men who already had been treated with Johnson & Johnson’s competitor product Zytiga. Read More
Manufacturers estimate that a medium-sized drugmaker would have to pay roughly $36 million to implement a serialization and traceability system required under the new federal track-and-trace law. Read More
MarCor Purification, a maker of water purification systems for the life sciences, has been warned by the FDA over CAPAs, investigations and complaint handling. Read More
The FDA has released a proposed rule that would allow it to destroy certain drug imports that have been refused admission into the U.S., the agency’s latest attempt to boost the integrity of the U.S. drug supply chain. Read More
The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. Read More
A new Citizen Petition contends the FDA should revoke Ranbaxy’s first-to-file market exclusivity status on several lucrative generic drugs due to a clear history of manufacturing problems and intentional false statements made by the Indian generics company. Read More
Manufacturers looking to speed up drug approvals in Europe, and ensure their products will be covered by payers, should initiate early parallel conversations with both the European Medicines Agency and the Health Technology Assessment Bodies (HTABs), the EMA says. Read More
A quartet of GOP senators is criticizing the FDA for relying on draft guidances to implement policy instead of rulemaking, and is clamoring for answers on how long it takes the agency to finalize drafts. Read More