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Alkermes says its once-monthly injectable version of the antipsychotic blockbuster Abilify met its endpoints in a Phase III trial, setting it up for an NDA filing with the FDA sometime in the third quarter. Read More
Drugmakers and non-profit collaborators are releasing the results of failed cancer trials so that researchers can examine the datasets to look for signals or other useful information that may suggest new research directions. Read More
Takeda Pharmaceutical and Eli Lilly Monday were ordered to pay a combined $9 billion in punitive damages after a federal court jury found they hid the cancer risks of their Actos diabetes medicine. Read More
Teva Pharmaceuticals asked U.S. Supreme Court Chief Justice John Roberts to recall and stay a July 2013 appeals court ruling invalidating a patent on Teva’s blockbuster multiple sclerosis drug Copaxone, pending the full court’s final decision on the patent case. Read More
The UK’s pharma regulator Monday began accepting applications for its Early Access to Medicines Scheme to allow not-yet-approved drugs for life-threatening diseases quicker interim approvals so they can be distributed to patients. Read More
Zogenix Monday sought a temporary restraining order against Massachusetts Gov. Deval Patrick’s recent executive order prohibiting use of the prescription pain drug Zohydro ER in the state. Read More
Shire Pharmaceuticals is recalling three lots of Gaucher disease drug Vpriv after finding stainless steel and barium sulfate particles in a small number of vials. Read More
The FDA will hold a public workshop in early May to discuss the development of standards for the interoperable exchange of information pertaining to prescription drug tracing. Read More
Compounding pharmacies have flooded the FDA with hundreds of comments seeking to protect access to bulk drug substances they use to make products. Read More