Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Bio Usawa, Cosmo, Gondolabio, GSK, Hoth, Immusoft, Quoin, Torii, Verrica.
Biopharma happenings, including deals and partnerships, and other news in brief: Arrowhead, Austrianova, Avant, CSL, Galapagos, Novartis, Pacira, Purdue, Roche, Teli, Telomir, Teva, Ventus.
Takeda Pharmaceutical Co. Ltd. agreed to codevelop and commercialize up to three of Innovent Biologics Co. Ltd.’s immuno-oncology (I-O) and antibody-drug conjugate (ADC) candidates with the signing of a $11.4 billion deal, including $1.2 billion paid up front.
Expedition Medicines, which Flagship Pioneering Inc. has incubated for the past three years, came out of stealth mode with a $50 million commitment from Flagship to support Expedition’s platform technology to discover small molecules that covalently bind to their target.
Newco Elevara Medicines Ltd. has raised $70 million in a series A to fund a phase IIa/IIb trial of ELV-001, a first-in-class, oral cyclin dependent kinase 4/6 inhibitor, in the treatment of rheumatoid arthritis (RA) patients who do not have an adequate response to methotrexate and anti-TNF biologic therapies.
The failure of Alector Inc.’s phase III study of latozinemab in treating dementia halved the company’s stock on Oct. 22. That is also about the same percentage of staff that Alector is letting go after the clinical trial stumble.
Having reached peace with Jazz Pharmaceuticals plc over litigation related to its U.S. FDA-approved drug, Lumryz (sodium oxybate), Avadel Pharmaceuticals plc agreed to a cash takeover by Alkermes plc valued at about $2.1 billion, a deal Alkermes CEO Richard Pops said “puts us in the sleep market immediately on closing,” which is expected in the first quarter of 2026. All three players are based in Dublin.
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