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Ono and Mediar Partner to Develop Antibody Therapies for Fibro-Inflammatory Diseases
Shots: Ono has entered into a drug discovery partnership & option agreement with Mediar Therapeutics to develop novel antibody therapeutics for fibro-inflammatory diseases As per the deal, Mediar will conduct research using its fibrosis-focused research platform, while Ono will gain exclusive worldwide option rights to select candidates for development, manufacturing, & commercialization The partnership will…
2 hours ago
FDA Grants Accelerated Approval to Replimune’s Tudriqev + Opdivo for Unresectable Cutaneous Melanoma Progressed on Anti-PD-1 Based Regimen
Shots: FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg or RP1) + nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on an anti-PD-1 antibody-based regimen P-II (IGNYTE) trial enrolled 140 pts, with 91 efficacy-evaluable pts having ≥1 non-injected lesion. Tudriqev + nivolumab achieved a 24.2% ORR & an mDoR of 14.1mos., with results…
3 hours ago
Tarsus Pharmaceuticals to Acquire Alkeus Pharmaceuticals for ~$800M
Shots: Tarsus Pharmaceuticals has entered into a definitive agreement to acquire Alkeus Pharmaceuticals, incl. its lead asset gildeuretinol (ALK-001), expanding Tarsus’ presence in retina care As per the deal, Alkeus will receive ~$450M upfront ($270M cash + $180M in Tarsus stock priced at $61.38/share), plus ~$350M in regulatory & commercial milestones, & low single-digit tiered descending…
21 hours ago
Alteogen Licenses ALT-B4 to a Global Pharmaceutical Company in a ~$365M Deal
Shots: Alteogen has entered into an exclusive license agreement with a global pharmaceutical company to develop & commercialize a SC formulation of a biologic product utilizing ALT-B4 (berahyaluronidase alfa) As per the deal, the company will acquire exclusive global rights to the SC formulation of a biologic product. In exchange, Alteogen will receive ~$365M, incl.…
23 hours ago
Schrödinger and Bristol Myers Squibb Expand AI Collaboration with Bunsen
Shots: Schrödinger has entered into a strategic agreement with BMS to deploy Bunsen, its agentic AI co-scientist, across BMS's research organization, expanding the companies' long-standing partnership As per the deal, Schrödinger will work with BMS to develop new Bunsen capabilities alongside its computational technologies for large-scale chemical exploration & RetroSynth, its AI-driven synthesis planning platform …
1 day ago
BlueWind Medical Receives FDA Clearance for Revi Extend Implant
Shots: The US FDA has granted 510(k) clearance to Revi Extend, the next-generation implant for Revi System to treat urgency urinary incontinence (UUI), with the new implant offering an extended lifespan of 15yrs.Limited US launch planned for Q4’26 Built on Implantable Tibial Neuromodulation (ITNM), Revi System is designed to reduce the long-term treatment burden through…
1 day ago
Takeda
Takeda Reports US FDA Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1
Shots: The US FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. DEA scheduling decision is expected within 90 days, after which it will be available through a specialty pharmacy Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in…
1 day ago
Summit Therapeutics Initiates P-II/III (HARMONi-GU1) Trial of Ivonescimab + Enfortumab Vedotin in Bladder Cancer
Shots: Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…
2 days ago
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