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Regulatory: FDA clears Roivant’s oral brepocitinib for dermatomyositis
The FDA approved Roivant’s oral therapy brepocitinib for dermatomyositis, giving the company its first major regulatory win in the condition. The drug will be marketed as Lisraya and is dosed once...
Oncology regulation: Revolution Medicines’ Rasonque approved for pancreatic cancer
The FDA approved Revolution Medicines’ daraxonrasib, marketed as Rasonque, for advanced pancreatic ductal adenocarcinoma, following clinical evidence that supports a survival benefit over standard...
Immuno-oncology safety signal: Tarlatamab case report flags tumor lysis risk
A case report published in Respirology Case Reports described fatal tumor lysis syndrome after a single 1-milligram starter dose of tarlatamab in a woman with relapsed small cell lung cancer. The...
Dealmaking: Genentech expands into ADC-resistant cancers with DualityBio
Genentech struck a strategic deal with DualityBio to pursue antibody-drug conjugates aimed at ADC-resistant cancers. Roche’s unit will pay $45 million upfront, with the overall transaction valued...
Diagnostics expansion: Roche wins expanded FDA clearance for tests tied to Jazz’s Ziihera
Roche received expanded FDA authorization for companion diagnostics tied to Jazz Pharmaceuticals’ oncology drug Ziihera. The new clearance allows Roche’s PATHWAY HER2 and VENTANA HER2 Dual ISH DNA...
Regulatory and trial updates: AstraZeneca/Amgen Tezspire expands toward EoE label
A Phase 3 study met endpoints for Tezspire (tezepelumab) in eosinophilic esophagitis (EoE), according to reporting on the trial outcome. AstraZeneca and Amgen said the results supported the drug’s...
Funding: Gates Foundation commits to ProFound Therapeutics for preeclampsia/eclampsia target discovery
The Gates Foundation is investing up to $35 million in ProFound Therapeutics to identify biomarkers, drug targets, and candidate therapies for preeclampsia and eclampsia. The funding includes an...
Clinical trial setbacks: Spyre’s anti-TL1A rheumatoid arthritis program is deprioritized
Spyre Therapeutics said it is deprioritizing its rheumatoid arthritis antibody candidate after failing to meet its success bar in a Phase 2 study. The decision follows data described as modest in...
CDMO/Cell therapy services: Bristol Myers ends Cellares collaboration over Breyanzi manufacturing requirements
Bristol Myers Squibb ended its collaboration with Cellares, a cell-therapy CDMO, citing manufacturing requirements tied to Breyanzi (lisocabtagene maraleucel). The termination follows reports that...
FDA approvals – pancreatic cancer and immunology indication expansion
The FDA approved Revolution Medicines’ daraxonrasib (Rasonque) for advanced pancreatic adenocarcinoma, a rapid regulatory decision that makes the first RAS inhibitor available in this setting. The...
ADC partnerships and next-gen pipeline deals
Genentech agreed to pay DualityBio $45 million upfront for rights to antibody-drug conjugates built for patients whose cancers become resistant to ADCs. The pact is structured for more than $1...
Late-stage setbacks – AstraZeneca/ Ionis heart disease gene silencer stumble
A high-profile Phase 3 failure for AstraZeneca and Ionis Pharmaceuticals’ Wainua (eplontersen) undercut expectations at ESC26 for the “heart disease gene silencer” strategy. The reporting...
Cell and gene therapy business moves – outsourcing and MRD partnerships
Cellares faces a financial and operational reset after Bristol Myers Squibb terminated a $380 million partnership tied to manufacturing for CAR T-cell therapy Breyanzi (lisocabtagene maraleucel)....
Gene therapy platform and diagnostic expansion – Roche expanded clearance and FDA orphan docket
Roche won expanded FDA clearance for diagnostic tests linked to Jazz Pharmaceuticals’ Ziihera, expanding companion testing into first-line HER2-positive stomach and gastroesophageal cancers....
New approvals in rare autoimmune disease – Roivant’s Lisraya for dermatomyositis
The FDA approved Roivant’s dermatomyositis drug brepocitinib for the treatment of dermatomyositis, with the pill marketed as Lisraya. The approval provides an initial major regulatory validation...
Clinical pipeline execution – Aprea accelerates Phase 1 WEE1 inhibitor development
Aprea Therapeutics is accelerating enrollment in its Phase 1 program for APR-1051, a WEE1 kinase inhibitor, after early signals of clinical activity. The company plans to expand active sites from...
Startup funding and diagnostic innovation – STI testing grant and MRD plus retrieval workflow
Readily Diagnostics secured a $970,000 Gates Foundation grant to develop a point-of-care sexually transmitted infection test for low-resource settings. The test uses isothermal padlock probe...
AI+biotech translational infrastructure – KITE vector analytics and NSF genome-geometry center
Kite Pharma, a Gilead company, described a new method to characterize individual lentiviral vector particles using flow virometry. The approach is designed to improve understanding of in vivo CAR...
M&A and market infrastructure – McKesson to acquire Precision Medicine Group
McKesson agreed to acquire Precision Medicine Group in an all-cash deal valued at about $2.25 billion to expand oncology clinical research and commercialization services. The combination aims to...
Pancreatic cancer—first-in-class RAS inhibition gets FDA approval
FDA cleared Revolution Medicines’ daraxonrasib (Rasonque), marking the first approved RAS inhibitor for advanced pancreatic ductal adenocarcinoma. The approval supports use in previously treated...