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Alexion (AstraZeneca) and Neurimmune Expand Alliance to Develop NI009 for AL Amyloidosis

Shots: Neurimmune has entered into an exclusive global collaboration & licensing deal with Alexion to develop NI009, a preclinical human mAb for the treatment of AL amyloidosis Alexion will obtain an exclusive global license to Neurimmune’s AL amyloidosis–targeting Abs, incl. NI009, with Neurimmune handling preclinical activities, early manufacturing & the FIH study, while Alexion will…
December 5, 2025

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Cardiawave Receives CE Mark for Valvosoft to Treat Severe Symptomatic Aortic Stenosis  

Shots: Cardiawave has received the European CE Mark for its Valvosoft to treat Severe Symptomatic Aortic Stenosis (sSAS) Valvosoft delivers precise high-intensity ultrasound that induces non-thermal, mechanical energy to soften aortic valve leaflets tissues, restoring their mobility & improving anatomical & hemodynamic function Valvosoft was evaluated in the Valvosoft FIM Study (24mos.) & Pivotal Study…
December 5, 2025

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Merck Animal Health
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Merck Animal Health’s Exzolt Cattle-CA1 Receives the US FDA Conditional Approval Against New World Screwworm and Cattle Fever Tick

Shots: The US FDA has granted conditional approval to Exzolt Cattle-CA1 to prevent & treat New World screwworm (Cochliomyia hominivorax) larvae (myiasis) & cattle fever tick (Rhipicephalus microplus) Exzolt Cattle-CA1, a systemic fluralaner pour-on available in 1L & 5L presentations, is approved for use in beef cattle (≥2mos.) & replacement dairy heifers (<20mos.), with US availability…
December 5, 2025

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Kelun-Biotech and Crescent Biopharma Enter Strategic Deal to Accelerate CR-001 and SKB105 Programs

Shots: Crescent granted Kelun exclusive rights to research, develop, manufacture & commercialize CR-001 in Greater China, while Kelun granted Crescent similar exclusive rights for SKB105 globally (excl. Greater China) Kelun will receive $80M upfront, ~$1.25B in milestones, tiered mid–single to low-double-digit royalties & potential change-of-control payments, while Crescent will get $20M upfront, ~$30M in milestones…
December 5, 2025

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Lupin and Valorum Biologics Join Forces to Commercialize Armlupeg (Biosimilar, Neulasta) in the US

Shots: Lupin has entered into an exclusive licensing agreement with Valorum Biologics for Armlupeg, a biosimilar version of Neulasta (pegfilgrastim) As per the deal, Valorum will be responsible for the commercialization and distribution of Armlupeg in the US, while Lupin will handle manufacturing & supply of the product In return, Lupin will receive an upfront…
December 4, 2025

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Medtronic Receives the US FDA clearance for Hugo RAS system for Urologic Surgical Procedures

Shots: The US FDA has granted clearance to Hugo robotic-assisted surgery (RAS) system for use in minimally invasive urologic surgical procedures, incl. prostatectomy, nephrectomy, & cystectomy The Hugo RAS system met its primary safety & efficacy endpoints in the Expand URO IDE study, showing performance in urologic procedures consistent with outcomes reported in published literature…
December 4, 2025

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Formycon Partners with MS Pharma to Commercialize FYB206 (Biosimilar, Keytruda) in the MENA Region

Shots: Formycon has entered into an exclusive licensing & supply agreement with MS Pharma for the commercialization of Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the MENA region As per the deal, Formycon will receive an upfront payment, potential development & regulatory milestones, & a significant share of regional gross profits, though…
December 4, 2025

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Iolyx Therapeutics Enters a Strategic Deal with Laboratoires Théa for ILYX-002 to Treat Ocular Surface Conditions

Shots: Iolyx has granted Théa exclusive global rights (excl. Asia) to develop & commercialize ILYX-002 for Dry Eye Disease associated with systemic autoimmune disorders & other ocular surface conditions Iolyx will receive ~$280M in clinical, regulatory, & commercial milestones; tiered royalties up to ~21%; & R&D cost reimbursement. Iolyx will design P-III trials, handle manufacturing,…
December 4, 2025

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