AstraZeneca and Amgen said Tezspire met Phase 3 goals in eosinophilic esophagitis, a market where Dupixent is the only approved biologic. The result extends Tezspire’s immunology expansion, but the competitive case still depends on data the companies have not yet disclosed.
AstraZeneca and Amgen said Tezspire met Phase 3 goals in eosinophilic esophagitis, a market where Dupixent is the only approved biologic. The result extends Tezspire’s immunology expansion, but the competitive case still depends on data the companies have not yet disclosed.
READ MORE
Genentech agreed to pay DualityBio $45 million upfront in a deal worth more than $1 billion in potential milestones for ADC programs aimed at tumors that progress after existing topoisomerase-based drugs. The pact points to a new investment theme inside the crowded ADC field: designing for the resistance setting rather than only chasing new targets.
Newly obtained documents conflict with Robert F. Kennedy Jr.'s statements to lawmakers that his 2019 Samoa trip had nothing to do with vaccines. The dispute matters beyond the trip itself because it cuts into the trust basis on which some senators backed his confirmation.
The Food and Drug Administration approved Roivant and Priovant's brepocitinib for dermatomyositis. The decision gives patients a new oral option in a disease where high-dose steroids and other immune-suppressing drugs are the current standard of care.
Generate Biomedicines said three posters tied to its AI-engineered anti-TSLP antibody GB-0895 were inadvertently made public ahead of a European Respiratory Society Congress embargo. The leak revealed new Phase 1 COPD and asthma findings and was followed by a stock pullback from the company’s Aug. 25 high.
Osivax has licensed GC Biopharma’s influenza vaccine outside Japan and Korea to build a combination candidate with OVX836. The deal turns earlier co-administration data into a more commercially practical push for a single flu shot.
Hospital leaders are pursuing a long-shot effort to delay, soften or partially reverse nearly $1 trillion in Medicaid cuts built into President Trump’s tax cut law. The strategy mixes immediate pressure for carveouts and payment offsets with a longer political bet on future Democratic gains.
ProFound Therapeutics will receive $20 million upfront and could collect another $15 million in milestone payments to search placental tissue for biomarkers and drug targets in preeclampsia. The deal extends a partnering model built around proteomics data and AI-assisted target interpretation in an area with limited R&D investment.
A BioSpace roundup highlighted three separate signals: Capricor’s Duchenne muscular dystrophy review remains active after a three-month FDA extension, Moderna and Merck posted an early Phase 3 melanoma vaccine readout, and Heidi Overton emerged as President Donald Trump’s pick for permanent FDA leadership. Together they point to a market still trading heavily on regulatory timing and leadership stability.
Akeso said ivonescimab plus chemotherapy beat AstraZeneca’s Imfinzi plus chemotherapy on overall survival in a China phase 3 trial in first-line advanced biliary tract cancer. The result gives the company its first late-stage success for the PD-1xVEGF bispecific outside lung cancer while investors remain focused on Summit Therapeutics’ upcoming Harmoni-3 readout in NSCLC.
Vitruvias Therapeutics is recalling 3,655 units from a single lot of generic Thyroid Tablets, USP 30 mg, after testing confirmed the potential for superpotency. The company also states on its website that it has ceased operations and transferred its products to H2-Pharma.
