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The FDA has been quicker to approve new active substances over the last decade than both its European and Japanese counterparts, a recent study finds. Read More
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
Sun Pharma is in the midst of another quality problem, this time involving a massive recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. Read More
Teva is making a last-second attempt to delay generic versions of its multiple sclerosis drug Copaxone from hitting the market, asking a federal court to require ANDA seekers to submit more data. 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