Allergan, Senju and Kyorin agreed to pay pharmaceuticals purchaser Hartig Drug $9 million to settle a product -hopping class-action lawsuit. Source: Drug Industry Daily
The FDA revised its Manual of Policies and Procedures document pertaining to issuing complete and partial clinical holds, including a reorganized background section that consolidates descriptions of IND clinical hold…
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on eligibility criteria for its Regenerative Medicine Advanced Therapy designation in comments on the agency’s draft guidance, while industry trade groups…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
AbbVie and Voyager Therapeutics inked a collaboration deal to develop treatments for Alzheimer’s disease and other neurodegenerative diseases. 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