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A federal judge has tossed out UK-based Reckitt Benckiser Pharmaceuticals’ patent infringement lawsuit against BioDelivery Sciences International over its competing product to Reckitt’s Suboxone, ruling that the court didn’t have jurisdiction because BioDelivery’s drug has yet to be approved. Read More
Both sides in a patent lawsuit involving the drug Suprep are asking a federal appeals court to reconsider its opinion in the case, saying the court set a dangerous precedent for future Hatch-Waxman patent suits because it recognized infringement for unapproved uses and clouds the definition of “patient” when it comes to the patent claim. Read More
Pfizer suffered a setback May 20 in its efforts to defend itself against charges that a division of the company illegally slowed generic competition on the muscle relaxant Skelaxin. Read More
Generic firm Mylan said Monday that it had reached a settlement with Pfizer to market versions of Celebrex (celecoxib), marking the latest twist in the generic conversion of the blockbuster arthritis pain drug. Read More
The FDA is trying to encourage mobile app and web developers to give wide distribution to drug adverse events data by providing the data in an easy-to-use electronic format. Read More
Sun Pharma is in the midst of another quality problem, this time involving a recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. 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
European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official told DGR. Read More