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A federal court panel has resurrected a class action lawsuit against Pfizer that alleges the drug giant deceived shareholders by downplaying cardiovascular risks linked to Celebrex and Bextra. Read More
Janssen has moved to a continuous manufacturing process at one of its facilities after getting the green light Friday from the FDA to switch from batch production, making it the first drugmaker allowed to change its production method. Read More
Valeant Pharmaceuticals is in Congress’ crosshairs again — with one lawmaker demanding the drugmaker turn over documents related to an investigation into the company’s relationship with Philidor Rx Services. Read More
The Kentucky state Senate has passed a bill in a 36 to 1 vote that would permit interchangeable biosimilar substitution. The FDA has not yet approved an interchangeable biosimilar. Read More
A three-judge panel for the U.S. Court of Appeals for the Federal Circuit has upheld two Depomed patents, enabling it to resume its lawsuit against Purdue Pharma. Read More
The FTC is arguing that a district court erred in failing to apply the Supreme Court ruling in FTC v. Actavis in a pay-for-delay case involving GlaxoSmithKline’s Wellbutrin XL antidepressant. Read More
As it bolsters efforts to tackle the growing opioid epidemic, the FDA last month outlined what tests sponsors of abuse-deterrent generic opioids should submit. Read More
A first cycle approval of a generic drug would ensure quick access in the market and eliminate the need for additional communications with the FDA. However, this may not always be possible, as GDUFA I does not provide for adequate communication between industry and the agency during the presubmission and ANDA review stages, Aloka Srinivasan, a principal consultant at PAREXEL International said in a recent FDAnews webinar. Read More
Participation in biosimilar development program activities with the FDA has seen a steady uptick over the past three fiscal years — from 33 in fiscal 2013, to 57 last year — according to an analysis by independent consulting firm Eastern Research Group. Read More