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…

ByRidhi RastogiNovember 26, 2025

INSIGHTS+

New Drug Designations – October 2025

Shots: PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA  The October 2025 report covers designations granted to 56 drugs and 9 medical devices, spanning 23 small molecules, 14 biologics, 10 cell and gene therapies & 9 medical devices, among…

ByRidhi RastogiNovember 25, 2025

NEWS

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…

ByRidhi RastogiNovember 25, 2025

NEWS

Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: The EC has approved Dupixent to treat mod. to sev. CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment & naïve to anti-IgE therapy based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program Study A & C (N=284) assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg…

ByRidhi RastogiNovember 25, 2025

NEWS

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…

ByRidhi RastogiNovember 25, 2025

NEWS

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…

ByRidhi RastogiNovember 25, 2025

NEWS

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…

ByRidhi RastogiNovember 25, 2025

NEWS

BMS’ Breyanzi Receives the EC Approval to Treat R/R Mantle Cell Lymphoma

Shots: The EC has approved Breyanzi (lisocabtagene maraleucel) for the treatment of adults with r/r mantle cell lymphoma (MCL) after ≥2L of systemic therapy, incl. a BTK inhibitor, in all 30 EEA states Approval was based on the MCL cohort of the P-I (TRANSCEND NHL 001) trial assessing Breyanzi in adults with r/r B-cell non-Hodgkin…

ByRidhi RastogiNovember 25, 2025

NEWS

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…

ByRidhi RastogiNovember 24, 2025

NEWS

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…

ByRidhi RastogiNovember 24, 2025

Ridhi Rastogi

Teva Receives EC Approval for Ponlimsi and Degevma (Biosimilar, Prolia and Xgeva) to Treat Bone and Skeletal Disorders

New Drug Designations – October 2025

Gilead Acquires TREX1 Program from Sprint Bioscience for ~$414M

Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Kelun-Biotech Reports P-III (OptiTROP-Lung05) Trial Data on Sacituzumab Tirumotecan + Keytruda for PD-L1-Positive NSCLC

Biogen Partners with Dayra Therapeutics to Advance Oral Macrocyclic Peptides for Immunological Conditions

Novartis’ Itvisma Receives the US FDA Approval for Spinal Muscular Atrophy

BMS’ Breyanzi Receives the EC Approval to Treat R/R Mantle Cell Lymphoma

Alvotech Reports the EC Approval of AVT03 (Biosimilar, Prolia and Xgeva)

Transmural Systems Receives the US FDA 510(k) Clearance for TELLTALE to Prevent Coronary Obstruction During TAVR

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