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NEWS

TaiGen Completes Enrolment and Doses First Patient with Insilico Medicine’s ISM4808 in P-I Trial

Shots: Insilico Medicine & TaiGen have reported complete enrolment of the trial & dosing of the first patient with ISM4808 in the P-I trial to treat CKD-related anemia The P-I study consists of both single-ascending-dose & multiple-ascending-dose cohorts, designed to evaluate ISM4808 in healthy adults against PBO In Dec 2025, TaiGen gained exclusive rights to…
March 6, 2026

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GAIA and Daiichi Sankyo Europe Partner to Launch Lipodia for Hypercholesterolemia in Europe

Shots: GAIA has entered into an exclusive strategic partnership with Daiichi Sankyo Europe to commercialize Lipodia, a digital therapeutic designed to support adults living with hypercholesterolemia, upon regulatory approval As per the deal, Daiichi Sankyo Europe will obtain exclusive rights to lipodia, initially covering Germany, with provisions to expand the partnership across major EU markets…
March 6, 2026

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J&J
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Johnson & Johnson Reports the US FDA Approval of Tecvayli + Darzalex Faspro for R/R Multiple Myeloma

Shots: The US FDA has approved Tecvayli (teclistamab-cqyv) + Darzalex Faspro (daratumumab & hyaluronidase-fihj) for the treatment of adults with r/r MM, who have received ≥1L of prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent Approval was based on the ongoing P-III (MajesTEC-3) study evaluating Tecvayli + Darzalex vs investigator’s choice of Darzalex & dexamethasone with…
March 6, 2026

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Harrison.ai Secures the US FDA 510(k) Clearance for Acute Infarct Triage on Non-Contrast CT Brain

Shots: The US FDA has granted 510(k) clearance to Harrison.ai’s acute infarct triage for non-contrast CT brain scans 510(k) submission compared infarct triage with existing stroke AI tools, incl. an FDA-cleared LVO device on non-contrast CT showing 63.5% sensitivity & 95.1% specificity for vessel occlusion detection only, plus CTA-based LVO systems that require contrast…
March 6, 2026

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NEWS

Tenaya Therapeutics and Alnylam Pharmaceuticals Partner to Discover Novel Genetic Targets for CV Therapies in ~$1.13B Deal

Shots: Tenaya has entered into a research collaboration with Alnylam to identify novel human genetic targets that could enable the development of disease-modifying therapies for cardiovascular (CV) diseases Under the collaboration, Tenaya will validate up to 15 gene targets, while Alnylam will lead all the development & commercialization of therapies arising from these validated targets…
March 6, 2026

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Airiver Medical Receives FDA Breakthrough Device Designation for Airiver DCB and Treats First Patient with Central Airway Stenosis

Shots: The US FDA has granted BDD to Airiver Pulmonary Drug Coated Balloon (DCB) to treat central airway stenosis Additionally, the first patient has been enrolled & treated in a trial evaluating the Airiver DCB vs SoC bare balloon dilation in ~200 pts with central airway stenosis; positive results could support a future FDA regulatory…
March 5, 2026

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Teva Lands $400M Blackstone Life Sciences Deal to Support Duvakitug Development

Shots: Teva & Blackstone Life Sciences have entered a four-year strategic funding agreement to support the continued clinical development of duvakitug As per the deal, Blackstone will provide $400M to Teva over four years to fund duvakitug development, while Blackstone will receive potential milestone payment subject to FDA approval, & additional commercial milestones, as well…
March 5, 2026

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