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NEWS
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, 20250Comments
NEWS
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, 20250Comments
NEWS
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, 20250Comments
NEWS
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, 20250Comments
Novartis
NEWS
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, 20250Comments
NEWS
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, 20250Comments