Merck & Co. Inc. has in-licensed Lanova Medicines Ltd.’s PD-1/VEGF bispecific antibody LM-299 in a deal worth up to $2.7 billion in a move to bolster its Keytruda (pembrolizumab) fortress. Under terms of the deal, Merck (known as MSD outside the U.S.) gains an exclusive global license to develop, manufacture and commercialize LM-299 in exchange for an up-front payment of $588 million. Shanghai-based Lanova is eligible to receive up to $2.7 billion in milestone payments associated with the technology transfer, development, regulatory approval and commercialization of LM-299 across multiple indications.
Apollo Therapeutics Group Ltd. and Sunshine Lake Pharma Co. Ltd. inked a potential $938 million licensing deal for APL-18881 (HEC-88473), Sunshine’s dual fibroblast growth factor 21 (FGF21)/glucagon-like peptide-1 (GLP-1) receptor agonist currently in a phase II study for type 2 diabetes.
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
Celltrion Inc. said it would acquire Iqone Healthcare Switzerland SA in the fourth quarter of 2024 for about ₩30 billion (US$21.34 million) to expand its European business. “This move represents a strategic shift in our growth strategy,” Taehun Ha, Celltrion vice president and Europe head, said in a statement Nov. 15.
The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
Positive findings from a phase III trial of semaglutide in metabolic dysfunction-associated steatohepatitis (MASH) is moving Novo Nordisk A/S to expand the glucagon-like peptide-1 (GLP-1) agonist’s indications in the U.S. and Europe, the Danish pharma said, as the MASH field sights more novel therapies.
Drug regulators around the world have a unique opportunity – and, in some cases, a legal mandate – to remove the taint of forced labor from the biopharma supply chain. But some of them, including the U.S. FDA and Japan’s PMDA, may be turning a blind eye to those responsibilities, according to a recent report from the nonprofit Centers for Advanced Defense Studies.
Cureverse Inc. and Angelini Pharma SpA signed a potential $360 million deal for CV-01, an oral small-molecule candidate for Alzheimer’s disease and neurological disorders like epilepsy. As a novel candidate, CV-01 suppresses neuroinflammatory reactions through the Kelch-like ECH-associated protein 1 and nuclear factor erythroid 2-related factor signaling pathway.
Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in the newest episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.”
Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in the newest episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.”
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