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Boston Scientific to Acquire Penumbra for ~$14.5B
Shots: Boston Scientific has entered into a definitive agreement to acquire Penumbra, expanding its cardiovascular portfolio As per the deal, Boston Scientific will acquire Penumbra for $374/share, with Penumbra stockholders having the option to receive either $374 in cash or 3.8721 shares of Boston Scientific’s common stock, representing the enterprise value of ~$14.5B; closing expected…
Agenus Completes Strategic Collaboration with Zydus Lifesciences of ~$141M to Advance BOT+BAL Development & Expand US Manufacturing
Shots: Agenus has completed its strategic collaboration with Zydus Lifesciences to accelerate global development and potential commercialization of the BOT+BAL immunotherapy program As per the deal, Zydus gave $75M upfront payment to Agenus for US biologics manufacturing facilities, and Agenus is also eligible for Contingent Milestone Payments ~$50M in production-linked milestones. Zydus acquired common stock…
Sun Pharma Launches Unloxcyt (Cosibelimab-ipdl) for the Treatment of aCSCC
Shots: Sun Pharma has reported Unloxcyt (cosibelimab-ipdl) is now available in the US for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not eligible for curative surgery or radiation Approval of label update was based on long-term pivotal CK-301-101 data, showing improved ORR, including higher CR, and DoR without new…
Santhera Pharmaceuticals Reports Swissmedic’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy
Shots: Swissmedic has approved Agamree for the treatment of pts (≥4yrs) with Duchenne muscular dystrophy and expects launch in H2’26 Approval was based on pivotal P-IIb (VISION-DMD) data and EMA assessments, granting 15-year Swiss orphan drug exclusivity; Santhera retains exclusive Swiss distribution. Trial met its 1EP of Time to Stand (TTSTAND) velocity vs PBO at…
Sanofi
Sanofi Secures China Approval for Myqorzo and Redemplo in oHCM and FCS
Shots: China’s NMPA has approved Sanofi-licensed Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for triglyceride reduction in adults with familial chylomicronemia syndrome (FCS) on dietary control The approval of Myqorzo was based on the pivotal P-III (SEQUOIA-HCM) study in pts with symptomatic oHCM, while Redemplo’s approval was supported by…
Emergent BioSolutions Receives US FDA Approval of sNDA for NARCAN Nasal Spray with New Carrying Case to Reverse Opioid Overdoses
Shots: The US FDA has approved Emergent BioSolutions’ supplemental NDA (sNDA) for over-the-counter (OTC) NARCAN Nasal Spray to be packaged in a new, compact carrying case designed to improve portability and everyday preparedness The new carrying case includes two blister-packed doses with a Quick Start Guide and is intended to increase accessibility, discretion, and likelihood…
ImmunityBio Reports Positive Clinical Results of ANKTIVA Plus Checkpoint Inhibitors in NSCLC
Shots: ImmunityBio announced positive results from two clinical studies evaluating ANKTIVA (nogapendekin alfa inbakicept) in combination with checkpoint inhibitors (CPI) in non-small cell lung cancer (NSCLC), demonstrating statistically significant immune restoration across 151 pts In 1L NSCLC, the randomized QUILT-2.023 study showed a significant and sustained increase in absolute lymphocyte count (ALC) with ANKTIVA +…
Sandoz
Sandoz Receives EC Approval of Ondibta (Biosimilar, Lantus and SoloStar)
Shots: The EC has approved Ondibta, a biosimilar insulin glargine pre-filled pen, reference medicine Lantus and SoloStar, developed and registered by Gan & Lee Pharmaceuticals, anticipated launch by early 2027 Ondibta is approved for treating diabetes mellitus in pts (age≥ 2 yrs.) and matches Lantus, SoloStar in safety, quality, and efficacy In Dec 2018, Sandoz partnered with…
J&J Reports P-III Trial Outcomes Showing Tecvayli Monotherapy Extends PFS and OS in R/R Multiple Myeloma
Shots: J&J has reported positive topline Phase III (MajesTEC-9) results demonstrating that Tecvayli (teclistamab) monotx. significantly outperformed SoC in r/r multiple myeloma The study included patients with 1–3 prior therapies, all previously treated with anti-CD38 antibodies and lenalidomide. Most patients were refractory to anti-CD38 mAbs (85%), lenalidomide (79%), and their last therapy (>90%). Tecvayli achieved…
Genethon Signs Worldwide Licensing Agreement with AskBio (Bayer AG) to Advance Gene Therapy for Pompe Disease
Shots: Genethon has entered into an exclusive, worldwide licensing agreement with AskBio for the use of a patented component of AskBio’s investigational gene therapy AB-1009 for the treatment of Pompe disease The licensed component is based on a transgene encoding a truncated form of GAA, developed by Genethon, which demonstrated preclinical efficacy in correcting glycogen…