The Ministry of Food and Drug Safety (MFDS) approved South Korea’s first denosumab (Prolia/Xgeva) biosimilars, developed by Celltrion Inc. under the brand names of Stoboclo/Osenvelt (CT-P41) for respective indications, a move the company hopes will help secure first-mover advantage for the drugs, currently under review in the U.S. and Europe.
A new position paper from the International Society of Hypertension pinpoints the benefits and drawbacks of novel blood pressure management technology, including the latest cuff-based and cuffless and wearable devices like BP-measuring watches and rings.
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
Radiopharmaceutical company Telix Pharmaceuticals Ltd. has inked a deal worth up to AU$264 million (US$171 million) to license and develop next-generation radiopharma imaging and therapy technology targeting fibroblast activation proteins found in a wide range of cancers.
Endometriosis has been woefully under-recognized in the medical community, and consequently, the delay between onset and diagnosis is often quite long, with some women waiting up to 12 years for a diagnosis. Endometriosis affects about 10% of women, and about 190 million women worldwide live with endometriosis.
Vitalli Bio Inc. terminated a potential $477 million licensing deal for autoimmune disease drug, DWP-213388, signed a year ago with Daewoong Pharmaceutical Co. Ltd., although Vitalli still retains option rights to two more dual inhibitor candidates that could fetch up to $941 million.
Keymed Biosciences Co. Ltd. is out-licensing global rights, excluding China, for its bispecific antibody, CM-336, to Platina Medicines Ltd. in a deal worth up to $626 million plus sales royalties.
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.
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