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Agios Reports the US FDA Approval of Aqvesme for Anemia in Alpha or Beta Thalassemia
Shots: The US FDA has approved Agios’ Aqvesme (mitapivat) for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies (n=452), which met all 1EPs and 2EPs, demonstrating significant improvements in hemoglobin, fatigue, and reductions in transfusion burden vs PBO Aqvesme…
December 25, 2025
SN BioScience Receives US FDA ODD for SNB-101 in Gastric Cancer
Shots: US FDA has granted Orphan Drug Designation (ODD) to SN BioScience’s SNB-101 for the treatment of gastric cancer, including gastroesophageal junction cancer SNB-101 is currently under P-Ib/II development for small cell lung cancer and is being evaluated across multiple solid tumor indications in Korea, Europe and US SNB-101 is a polymer nanoparticle formulation of…
December 25, 2025
The US FDA Approves Edwards Lifesciences’ SAPIEN M3 Mitral Valve Replacement System for Mitral Regurgitation
Shots: The US FDA has approved Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement (TMVR) system as the transseptal transcatheter therapy for the treatment of symptomatic moderate-to-severe or severe mitral regurgitation (MR) SAPIEN M3 is indicated for pts unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy, including those with mitral valve dysfunction associated with…
December 25, 2025
Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)
Shots: Zydus Lifesciences has entered into a strategic licensing, supply & commercialization agreement with Bioeq for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, for the US market, marking an expansion of Zydus’ US biosimilar portfolio Under the agreement, Bioeq will handle development, manufacturing, registration & supply of the finished product while Zydus will lead US…
December 25, 2025
Rectify Pharmaceuticals and Boehringer Ingelheim Partner to Develop Small Molecules for Chronic Kidney Disease (CKD) 
Shots: Rectify has entered into a strategic research & licensing agreement with BI to accelerate the development of small molecule therapies for CKD & other conditions Collaboration will leverage Rectify’s positive functional modulators (PFM) platform to develop oral small molecules that restore or enhance ABCC6 function, targeting pathologic calcification to slow disease progression in CKD, Pseudoxanthoma elasticum,…
December 24, 2025
Ipsen Signs ~$1.06B Deal with Simcere Zaiming for SIM0613
Shots: Ipsen has entered into an exclusive licensing agreement with Simcere Zaiming for SIM0613 to treat solid tumors with the highest unmet needs Ipsen will secure global rights to SIM0613 outside Greater China, gain manufacturing rights after technology transfer, & assume responsibility for all development activities beyond Greater China, incl. P-I preparation & IND/CTA submissions As…
December 24, 2025
Sanofi to Acquire Dynavax for ~$2.2B
Shots: Sanofi has entered into an agreement to acquire Dynavax, incl. Heplisav-B (adult hepatitis B vaccine), Z-1018 (differentiated shingles vaccine candidate) & additional vaccine pipeline projects As per the deal, Sanofi will acquire Dynavax for $15.50/share in cash, representing the total equity value of ~$2.2B, after which a Sanofi subsidiary will merge with & into Dynavax…
December 24, 2025
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