NEWS

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

Junshi Biosciences Reports the NMPA’s sNDA Acceptance of Toripalimab + Disitamab Vedotin for Urothelial Carcinoma

Shots: China’s NMPA has accepted sNDA of toripalimab + disitamab vedotin for the treatment of HER2+ locally advanced or metastatic urothelial carcinoma (LA/M UC) sNDA was backed by P-III (RC48-C016) trial assessing toripalimab + disitamab vedotin vs gemcitabine + cisplatin/carboplatin across 74 centres in systemic-treatment-naïve Chinese pts with HER2+ LA/M UC Toripalimab is an anti-PD-1…

August 12, 2025

Stoke Therapeutics and Biogen Report First Patient Dosing in P-III (EMPEROR) Trial of Zorevunersen for Dravet Syndrome

Shots: Stoke Therapeutics & Biogen have dosed their first patient with zorevunersen in global P-III (EMPEROR) trial for the treatment of Dravet syndrome; Trial has initiated in the US, UK, & Japan, with an EU study planned Trial will assess zorevunersen (70mg on Day 1 & Wk. 8, then 45mg at Wks. 24 & 40) vs sham…

August 12, 2025

Expedition Therapeutics Enters a ~$645M Licensing Deal with Fosun Pharma for XH-S004

Shots: Fosun Pharma has granted Expedition global rights to develop, manufacture, & commercialize XH-S004, excl. Mainland China, Hong Kong SAR, & Macau SAR, where Fosun will retain its rights As per the deal, Fosun will receive $120M incl. upfront & development milestone payments, with ~$525M in sales milestones XH-S004 (DPP-1 inhibitor, PO) is being investigated…

August 12, 2025

Arvinas Reports the US FDA’s NDA Acceptance of Vepdegestrant for ESR1-Mutated Breast Cancer

Shots: The US FDA has accepted NDA of vepdegestrant to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy (PDUFA: Jun 5, 2026) NDA was backed by P-III (VERITAC-2) trial assessing vepdegestrant alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy Trial showed…

August 11, 2025

CSL Receives Health Canada’s Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: Health Canada has approved Andembry (garadacimab) for HAE pts (≥12yrs) Approval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean; data was published in The Lancet Interim analysis of the ongoing OLE…

August 11, 2025

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)

Junshi Biosciences Reports the NMPA’s sNDA Acceptance of Toripalimab + Disitamab Vedotin for Urothelial Carcinoma

Stoke Therapeutics and Biogen Report First Patient Dosing in P-III (EMPEROR) Trial of Zorevunersen for Dravet Syndrome

Expedition Therapeutics Enters a ~$645M Licensing Deal with Fosun Pharma for XH-S004

Arvinas Reports the US FDA’s NDA Acceptance of Vepdegestrant for ESR1-Mutated Breast Cancer

CSL Receives Health Canada’s Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

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