A federal judge overturned a $2.5 billion patent infringement verdict, the largest ever in a U.S. patent case, against Gilead Sciences in a dispute with Merck. Source: Drug Industry Daily
Biocom and Gilead Sciences asked the FDA for clarification on eligibility criteria for its Regenerative Medicine Advanced Therapy designation in comments on the agency’s draft guidance, while industry trade groups…
The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Imfinzi to treat patients with unresectable Stage III non-small cell lung cancer (NSCLC). Source: BioSpace
Dynavax announced it has secured a $175 million non-dilutive term loan agreement to commercialize Heplisav-B. Source: BioSpace
Federal court judge orders Merck to repay $2.5 Billion to Gilead in overturned patent decision. Source: BioSpace
Life sciences giant Johnson & Johnson may be shopping around its sterilization products division. Source: BioSpace
Nevada-based PDL BioPharma, Inc. said it will no longer pursue a proposed acquisition of Neos Therapeutics. Source: BioSpace
AbbVie and Voyager Therapeutics inked a collaboration deal to develop treatments for Alzheimer’s disease and other neurodegenerative diseases. Source: BioSpace
The Philadelphia District Attorney is suing opioid manufacturers and is the first to sue under Pennsylvania’s consumer protection law — making it a public enforcement action on behalf of all…
The FDA observed various GMP deficiencies in an inspection of a Legacy Pharmaceuticals Switzerland facility, including problems with sterility, maintenance and discrepancy investigations. Source: Drug Industry Daily