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Teva
Teva Receives EC Approval for Ponlimsi and Degevma (Biosimilar, Prolia and Xgeva) to Treat Bone and Skeletal Disorders
Shots: The EC has approved Ponlimsi & Degevma, biosimilar versions of Prolia & Xgeva (denosumab), respectively, following the CHMP positive opinion for bone health treatments Approval was based on comprehensive analytical, preclinical, & clinical data, demonstrating comparable quality, safety, & efficacy of Ponlimsi & Degevma to the reference product Ponlimsi & Degevma are anti-RANKL monoclonal…
November 26, 2025
Gilead Acquires TREX1 Program from Sprint Bioscience for ~$414M
Shots: Sprint Bioscience has reported the sale of its TREX1 cancer program to Gilead Sciences As per the Deal, Sprint Bioscience will receive $14M upfront and up to $400M in clinical, regulatory, and commercial milestones TREX1 program has demonstrated notable potential in the pre-clinical stage Ref: Sprint Bioscience | Image: Gilead & Sprint Bioscience | Press…
November 25, 2025
Kelun Biotech
Kelun-Biotech Reports P-III (OptiTROP-Lung05) Trial Data on Sacituzumab Tirumotecan + Keytruda for PD-L1-Positive NSCLC
Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung05) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs Keytruda monotx. as a 1L treatment for PD-L1-positive locally advanced or metastatic NSCLC with PD-L1 TPS ≥1% The trial met its 1EP of improved PFS, as concluded by IDMC & showed a favorable trend in the OS Additionally, the company…
November 25, 2025
Biogen Partners with Dayra Therapeutics to Advance Oral Macrocyclic Peptides for Immunological Conditions
Shots: Biogen has entered into a research collaboration with Dayra Therapeutics to discover & develop oral macrocyclic peptides for priority targets in immunological conditions Biogen & Dayra will jointly discover, validate, & optimize oral macrocycle candidates for key immunology targets, after which Biogen will lead development, manufacturing, & potential commercialization As per the deal, Dayra will…
November 25, 2025
Novartis
Novartis’ Itvisma Receives the US FDA Approval for Spinal Muscular Atrophy
Shots: The US FDA has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of pts (≥2yrs.) living with spinal muscular atrophy (SMA) harboring a confirmed mutation in the SMN1 gene; US availability expected in Dec 2025 Approval was based on the P-III (STEER) trial & open-label P-IIIb (STRENGTH) study, showing Itvisma improved motor function & stabilized…
November 25, 2025
Alvotech Reports the EC Approval of AVT03 (Biosimilar, Prolia and Xgeva)
Shots: The EC has approved AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab), in 60mg/mL PFS (Prolia) & 70mg/mL single-use vial (Xgeva) presentation Approval was based on extensive clinical data, incl. analytical, PK & PD data, plus data from AVT03-GL-C01 trial (vs Prolia) among postmenopausal women with osteoporosis, as well as AVT03-GL-P01 trial (vs…
November 24, 2025
Transmural Systems Receives the US FDA 510(k) Clearance for TELLTALE to Prevent Coronary Obstruction During TAVR
Shots: The US FDA has granted 510(k) clearance to TELLTALE for the prevention of coronary obstruction in pts undergoing Transcatheter Aortic Valve Replacement (TAVR) for both native aortic stenosis & bioprosthetic valve failure FDA cleared TELLTALE following a pivotal study demonstrating the device’s safety & effectiveness for leaflet modification in pts at risk of coronary…
November 24, 2025
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