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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…

20 hours ago

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…

21 hours ago

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…

22 hours ago

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…

24 hours ago

Roche and Zealand Pharma Report P-II (ZUPREME-1) Trial Data on Petrelintide in Obesity

Shots: The P-II trial assessed 5 doses of petrelintide (SC, QW) vs PBO for 42wks. in 493 overweight or obese pts (mean BMI of 37 kg/m²) with weight-related comorbidities Trial met its 1EP, with Q4W dose-escalated injections delivering significant weight loss across 5 arms after 28wks. & sustaining ~10.7% vs 1.7% mean reduction through Wk.…

1 day ago

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…

1 day ago

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…

2 days ago

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…

2 days ago

Akeso Presents P-II (COMPASSION-03) Trial Data on Cadonilimab for R/M Cervical Cancer at ESGO 2026

Shots: The P-II (COMPASSION-03/AK104-201) trial assessed cadonilimab in pts with recurrent or metastatic CC who have failed prior Pt-based CT, showing mOS of 17.5mos. in pts regardless of PD-L1 expression, with18 & 24mos. OS rates of 47.8% & 40.9%, respectively Updated data with 26.5mos. mFU showed that among 99 efficacy-evaluable pts achieving CR, mOS & PFS…

2 days ago

Sino Biopharmaceutical and Sanofi Partner to Advance Rovadicitinib in a ~$1.53B Deal

Shots: Sino Biopharm via its subsidiary Chia Tai Tianqing has entered into an exclusive license agreement with a fully owned subsidiary of Sanofi for rovadicitinib As per the deal, Sanofi will obtain exclusive global license to develop, manufacture & commercialize rovadicitinib in exchange for $135M upfront & ~$1.395B in development, regulatory & sales milestones, as…

2 days ago

NEWS

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

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

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

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

Roche and Zealand Pharma Report P-II (ZUPREME-1) Trial Data on Petrelintide in Obesity

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

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

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

Akeso Presents P-II (COMPASSION-03) Trial Data on Cadonilimab for R/M Cervical Cancer at ESGO 2026

Sino Biopharmaceutical and Sanofi Partner to Advance Rovadicitinib in a ~$1.53B Deal

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