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NEWS

Precigen’s Papzimeos Receives the US FDA’s Full Approval for Recurrent Respiratory Papillomatosis

Shots: The US FDA has granted full approval to Papzimeos (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis (RRP), even though its BLA was originally submitted under the accelerated approval pathway Approval was based on a P-I/II trial meeting its 1EP of safety as well as efficacy & showed 51% pts (18/35) achieving CR with…
August 18, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 11, 2025 – Aug 14, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Animal Health, and Biosimilars. Check out our full report below:    Novartis Reports Topline P-III (NEPTUNUS-1 & 2) Trials Finding on Ianalumab to Treat Active Sjögren’s Disease  Read More: Novartis  Stoke Therapeutics and Biogen Report First Patient Dosing in P-III (EMPEROR)…
August 14, 2025

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Sanofi
NEWS

Sanofi’s Rilzabrutinib Secures the EMA’s Orphan Drug Designation to Treat IgG4-Related Disease

Shots: The EMA has granted ODD to rilzabrutinib for the treatment of IgG4-related disease (IgG4-RD) Rilzabrutinib (PO) is being evaluated in a P-II trial for IgG4-RD with glucocorticoids vs glucocorticoids alone, showing reduced flares, improved disease markers, & steroid sparing over 52 weeks; data presented at EULAR 2025 Rilzabrutinib, a reversible covalent BTK inhibitor, is…
August 14, 2025

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NEWS

BioCardia Collaborates with CART-Tech to Advance Heart3D Fusion Imaging for Interventional Cardiology

Shots: BioCardia has entered into an exclusive development & commercialization agreement with CART-Tech for Heart3D Fusion Imaging to improve 2D x-ray images used for cardiac biotherapeutic delivery & biopsy procedures As per the deal, BioCardia secured global exclusive rights to CART-Tech’s IP for biotherapeutic interventions, plus exclusive US distribution rights for cardiac biopsy & global…
August 14, 2025

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Merck new
NEWS

Merck Receives Health Canada’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: Health Canada has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ±…
August 14, 2025

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NEWS

Mabwell Reports First Patient Dosing in P-I Trial of Bulumtatug Fuvedotin for Triple-Negative Breast Cancer (TNBC) in the US

Shots: Mabwell has dosed its first patient with Bulumtatug Fuvedotin (BFv or 9MW2821) in P-I trial for the treatment of TNBC pts Trial will assess safety & efficacy of BFv in TNBC pts previously treated with a taxane & an ADC with a topoisomerase inhibitor payload, measuring ORR as the 1EP Bulumtatug Fuvedotin, a Nectin-4–targeting…
August 13, 2025

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Remegen
NEWS

Remegen Reports P-III Trial Data of Telitacicept for Sjögren’s Syndrome in China

Shots: Remegen has reported P-III trial data assessing telitacicept vs PBO in pts with primary Sjögren's syndrome Trial met its 1EP of reduced EULAR Sjögren’s syndrome disease activity index (ESSDAI), showing improved disease activity at Wk. 24; NMPA’s BLA submission is planned, along with presentation of detailed data at an upcoming conference Telitacicept is a…
August 13, 2025

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NEWS

Greywolf Therapeutics Reports First Patient Dosing in P-I/II (EAST-1) Trial of GRWD0715 for Axial Spondyloarthritis

Shots: Greywolf Therapeutics has dosed its first patient with GRWD0715 in P-I/II (EAST-1) trial (n=~141) for the treatment of axial spondyloarthritis (axSpA) The P-I study will assess safety & tolerability of GRWD0715 in ~24 healthy participants & ~36 axSpA pts to utilize the results with proof-of-mechanism data for selecting the active dose for P-II trial…
August 13, 2025

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