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…

ByRidhi RastogiFebruary 25, 2026

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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…

ByRidhi RastogiFebruary 25, 2026

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The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)

Shots: FDA approved Dupixent for pts (≥6yrs.) with AFRS & have a history of sino-nasal surgery, based on the P-III (LIBERTY-AFRS-AIMS) trial, assessing age & weight-based Dupixent dosing (200 or 300mg; Q2W or Q4W; n=33) vs PBO (n=29) in 62 pts Trial met its 1EP with improved sinus opacification by 50% vs 10% at Wk. 52,…

ByRidhi RastogiFebruary 25, 2026

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J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia

Shots: The US FDA has received an sBLA of Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period Trial achieved stringent 1EP of a durable hemoglobin response & showed…

ByRidhi RastogiFebruary 25, 2026

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Frontier Biotechnologies and GSK Forge ~$1B Global Licensing Deal for siRNA Therapeutics

Shots: Frontier has entered into an exclusive licensing agreement with GSK for two Small Interfering RNA (siRNA) assets in immunology, incl. one IND-stage candidate & one preclinical program As per the deal, GSK will gain exclusive global rights to develop, manufacture, & commercialize two of Frontier’s siRNA candidates, while Frontier will receive $40M upfront, up…

ByRidhi RastogiFebruary 24, 2026

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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…

ByRidhi RastogiFebruary 24, 2026

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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,…

ByRidhi RastogiFebruary 24, 2026

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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…

ByRidhi RastogiFebruary 24, 2026

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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…

ByRidhi RastogiFebruary 24, 2026

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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…

ByRidhi RastogiFebruary 24, 2026

Ridhi Rastogi

SteinCares Forges Licensing Agreement with Shilpa Biologicals for Biosimilars Across Latin America

GSK to Acquire 35Pharma for $950M

The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)

J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia

Frontier Biotechnologies and GSK Forge ~$1B Global Licensing Deal for siRNA Therapeutics

Sciwind Biosciences and Pfizer China Partner to Commercialize Ecnoglutide in China

Merck Carves Out Oncology as Standalone Division

Sebela Pharmaceuticals Licenses Miudella to Organon in ~$532M Deal

Immedica Pharma Receives the US FDA Accelerated Approval for Loargys to Treat Hyperargininemia in Patients with ARG1-D

Astellas Partners with Vir Biotechnology for VIR-5500 in ~$1.7B Deal

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