Novartis AG lost its bid, at least for now, to delay generic competition to its blockbuster heart drug, Entresto (sacubitril, valsartan), on the basis of patent infringement.
The U.S. CMS has negotiated outcomes-based agreements with Bluebird Bio Inc. and Vertex Pharmaceuticals Inc. to make their costly sickle cell gene therapies the first treatments to become available through the voluntary Medicaid Cell and Gene Therapy Access Model.
Elevar Therapeutics Inc. will license Relay Therapeutics Inc.’s “NDA-ready” bile duct cancer therapy, lirafugratinib (RLY-4008), through a potential $500 million deal as Elevar, an HLB Co. Ltd. subsidiary, seeks to diversify its oncology portfolio following the U.S. FDA rejection of its liver cancer drug candidate in May.
Duality Biologics is out-licensing preclinical antibody-drug conjugate (ADC) candidate DB-1324 under an option agreement with GSK plc potentially worth more than $1 billion.
Methods that may work well for recruiting and retaining white patients for clinical trials may need to be adjusted to maximize the involvement of patients from other ethnic backgrounds. At Biocom California’s Let’s Talk About series, panelists discussed the benefits and best practices for adding diversity to clinical trials.
Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion that excludes mainland China, Hong Kong and Macau.
Shares of Relmada Therapeutics Inc. (NASDAQ:RLMD) plummeted 77% to close at 63 cents Dec. 4 after a pre-planned interim analysis prompted the independent data monitoring committee to conclude the phase III Reliance II study testing REL-1017 in major depressive disorder is likely to fail, leaving the future of the NMDA receptor channel blocker in doubt while the company looks ahead to an earlier-stage psilocybin-based program targeting metabolic disease.
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