NEWS

Basilea Pharmaceutica Enters Into a Licensing Deal with Venatorx Pharmaceuticals

Shots: Basilea Pharmaceutica entered into an exclusive license deal with Venatorx Pharmaceuticals to acquire global rights to ceftibuten-ledaborbactam etzadroxil, a P-III oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination for complicated urinary tract infections (cUTI), incl. pyelonephritis Under the agreement, Venatorx will receive an upfront payment along with potential milestone payments in 2025 and will also be eligible…

August 14, 2025

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

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

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

Myra Vision Receives FDA Conditional IDE Approval for Calibreye TGT System to Treat Glaucoma

Shots: Myra Vision received the US FDA conditional IDE approval to initiate its ADAPT study evaluating Calibreye Titratable Glaucoma Therapy (TGT) surgical system for glaucoma The IDE trial will evaluate the safety and efficacy of Calibreye TGT surgical system in ~70 refractory glaucoma pts with 12mos. primary effectiveness endpoint Calibreye System allows ophthalmologists to control…

August 13, 2025

Insmed Reports the US FDA’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The US FDA has approved Brinsupri (10 & 25mg) for treating NCFB pts (≥12yrs.); it is now available in the US. MAA is under EMA & MHRA review with a Japan filing planned in 2025 & potential launches in 2026 pending approvals Approval was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial…

August 13, 2025

Bayer Enters a ~$1.3B Deal with Kumquat Biosciences to Develop and Commercialize a KRAS G12D Inhibitor

Shots: Bayer has entered into an exclusive global license agreement & collaboration with Kumquat Biosciences to develop and commercialize its KRAS G12D inhibitor Kumquat will initiate & complete the P-Ia study following FDA’s IND clearance in Jul 2025, while Bayer handles further development & commercialization, with Kumquat holding an exclusive option to negotiate US profit-loss…

August 13, 2025

Merck and Pfizer Report Topline P-III (KEYNOTE-905) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-905/EV-303) trial randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B (surgery alone), or Arm C (3 cycles of Keytruda + Padcev before surgery, followed 6 cycles of the combination, then 8 cycles of Keytruda alone) Arms C & B showed improved…

August 12, 2025

Lupin Collaborates with Sandoz to Commercialize Ranibizumab Biosimilar

Shots: Lupin has entered into a licensing agreement with Sandoz to market & commercialize Lupin’s ranibizumab biosimilar in multiple regions As per the deal, Sandoz will commercialize the product in the EU (excl. Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, & Malaysia, while holding exclusive rights in most markets & semi-exclusive rights in France, Australia,…

August 12, 2025

Novartis Reports Topline P-III (VAYHIT2) Trial Finding on Ianalumab Regimen to Treat Primary Immune Thrombocytopenia (ITP)

Shots: Novartis has reported topline P-III (VAYHIT2) trial data assessing ianalumab (3 or 9mg/kg, QM, IV) + eltrombopag vs PBO + eltrombopag in pts with primary immune thrombocytopenia (ITP) who failed 1L corticosteroid treatment Trial met its 1EP with prolonged time to treatment failure & showed increased sustained platelet count improvement at 6mos. (2EP); data…

August 12, 2025

NEWS

Basilea Pharmaceutica Enters Into a Licensing Deal with Venatorx Pharmaceuticals

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

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

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

Myra Vision Receives FDA Conditional IDE Approval for Calibreye TGT System to Treat Glaucoma

Insmed Reports the US FDA’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Bayer Enters a ~$1.3B Deal with Kumquat Biosciences to Develop and Commercialize a KRAS G12D Inhibitor

Merck and Pfizer Report Topline P-III (KEYNOTE-905) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Novartis Reports Topline P-III (VAYHIT2) Trial Finding on Ianalumab Regimen to Treat Primary Immune Thrombocytopenia (ITP)

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