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A UK coalition of drugmakers and a cancer research group are launching an analysis of failed Phase III lung cancer drug trials that will search for treatments that, despite failing overall, are effective for certain subpopulations. Read More
Israeli drugmaker Teva announced Thursday it has reached a settlement with Pfizer to hold back marketing generic Celebrex (celecoxib) in the U.S. until December. Read More
The Justice Department’s crackdown on drugmakers that violate the False Claims Act continues, with Astellas’ U.S. division paying $7.3 million to settle claims it improperly marketed Mycamine. Read More
The European Medicines Agency is urging healthcare providers to inspect vials of the cancer drug Herceptin for signs of tampering following reports that some vials of the drug were stolen in Italy, tampered with and reintroduced into the supply chain. Read More
Baxter said Wednesday that its Bax 111 treatment for Von Willebrand disease met its primary endpoint in a pivotal clinical trial, setting it up for NDA filing later this year. Read More
Impax Laboratories said it has begun shipping generic Renvela tablets in the U.S. after securing a license from Genzyme to sell a specified number of bottles. Read More
The European Medicines Agency said Monday it has concluded its investigation into deficient postmarket reporting by Roche and forwarded a report to the European Commission, where penalties will be debated. Read More
Drugmakers should include information for all uses of a product — including off-label uses — when preparing periodic benefit-risk evaluation reports, the International Council on Harmonisation says in new Q&A guidance. Read More
The FDA has approved another under-the-tongue hay fever treatment, putting a second product on the market that will replace the routine injections currently prescribed to control symptoms. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American drugmakers. Read More