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SteinCares Forges Licensing Agreement with Shilpa Biologicals for Biosimilars Across Latin America
Shots: SteinCares has entered into a strategic licensing agreement with Shilpa Medicare to commercialize a biosimilar across Latin America (LATAM) As per the deal, SteinCares secures exclusive rights to register, commercialize, & distribute the biosimilar across the region, while SBPL will finalize development & undertake commercial manufacturing at its Dharwad, India facility Partnership combines SBPL’s…
GSK to Acquire 35Pharma for $950M
Shots: GSK has entered into an agreement to acquire 35Pharma, incl. its asset HS235, expanding scalable growth opportunities within its Respiratory, Immunology & Inflammation portfolio As per the deal, GSK will acquire 100% of 35Pharma’s equity for $950M in cash, payable at closing HS235, a therapy targeting the activin receptor signalling pathway, has completed P-I…
Sciwind Biosciences and Pfizer China Partner to Commercialize Ecnoglutide in China
Shots: Sciwind Biosciences has granted Pfizer China exclusive commercialization rights to Ecnoglutide injection in Mainland China As per the deal, Sciwind will retain the MA & will be responsible for R&D, registration, manufacturing, & supply, plus is eligible to receive ~$495M in upfront, regulatory, & sales milestones Independently developed by Sciwind, Ecnoglutide is a cAMP-biased…
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Merck Carves Out Oncology as Standalone Division
Shots: Merck has reorganized its Human Health division into two units: Oncology, and Specialty, Pharma & Infectious Diseases, to sharpen commercial execution & support a growing portfolio of launches across diverse therapeutic areas Jannie Oosthuizen has been appointed EVP & President, Oncology & MSD International, while Brian Foard will serve as EVP & President, Specialty,…
Sebela Pharmaceuticals Licenses Miudella to Organon in ~$532M Deal
Shots: Sebela Pharmaceuticals has entered into an agreement granting Organon exclusive global rights to Miudella, a hormone-free copper intrauterine device (IUD) contraceptive As per the deal, Sebela will receive $27.5M at closing & ~$505M in sales-based milestone payments, with tiered net sales-based double-digit royalties Miudella was approved by the US FDA in Feb 2025, for…
Immedica Pharma Receives the US FDA Accelerated Approval for Loargys to Treat Hyperargininemia in Patients with ARG1-D
Shots: The US FDA has granted accelerated approval to Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in pts (≥2yrs.) with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction, with commercial availability expected in Apr 2026 Approval was based on the P-III (PEACE) trial assessing Loargys vs PBO, which showed reduced plasma arginine from…
Astellas Partners with Vir Biotechnology for VIR-5500 in ~$1.7B Deal
Shots: Astellas has partnered with Vir Biotechnology to advance VIR-5500, a PRO-XTEN dual-masked CD3 T-cell engager targeting PSMA, for the treatment of prostate cancer As per the deal, Astellas will fund 60% & Vir 40% of global development costs; Vir will continue the P-I trial until transition, after which Astellas will assume development. Also, Vir will…