We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Despite limited data and only one positive Phase 3 trial, an FDA panel voted 12‒2 to recommend Acadia Pharmaceuticals’ Nuplazid for treating psychosis associated with Parkinson’s disease. Read More
After a French Phase 1 clinical trial in January designed by Portuguese drugmaker Bial Laboratories left one patient dead and another six hospitalized, an Agency for Medicines and Health Products Safety-appointed committee determined that an “off-target effect” of the compound is a probable explanation of the tragedy. Read More
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