NEWS

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

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

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.…

March 6, 2026

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

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

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

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…

March 5, 2026

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…

March 5, 2026

Antengene and UCB Strike ~$1.18B Deal to Advance ATG-201 for B-Cell–Related Autoimmune Diseases

Shots: Antengene has granted UCB a global exclusive license to develop, manufacture, & commercialize ATG-201 for B-cell–related autoimmune diseases, plus access to Antengene’s associated manufacturing tech supporting the therapy As per the deal, Antengene will receive $80M in upfront & near-term milestones & ~$1.1B in development & commercial milestones, as well as net sales-based tiered…

March 5, 2026

Moderna settles LNP Patent Dispute with Genevant Sciences and Arbutus Biopharma for ~$2.25B

Shots: Genevant & Arbutus reached a global settlement with Moderna to resolve all US & international disputes over the alleged unauthorized use of their LNP delivery technology in the COVID-19 vaccines, incl. Spikevax As part of the settlement, Moderna will pay $950M upfront to Genevant & Arbutus in Jul 2026 & ~$1.3B more pending…

March 5, 2026

NEWS

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

Antengene and UCB Strike ~$1.18B Deal to Advance ATG-201 for B-Cell–Related Autoimmune Diseases

Moderna settles LNP Patent Dispute with Genevant Sciences and Arbutus Biopharma for ~$2.25B

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