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Vertex’s kidney drug clears Phase 3 — FDA filing imminent
Vertex announced a positive Phase 3 readout for povetacicept, its acquired candidate for IgA nephropathy, and plans an expedited path to regulators. The company said the trial met its primary...
BioNTech founders exit to launch next‑gen mRNA spinout
BioNTech co‑founders Ugur Sahin and Özlem Türeci announced they will step down by year‑end to start a new company focused on next‑generation mRNA therapeutics. BioNTech said it will grant the...
Xenon’s epilepsy pill smashes expectations — filing set for Q3
Xenon Pharmaceuticals reported a commanding Phase 3 X‑Tole2 result for azetukalner in focal onset seizures, with placebo‑adjusted seizure reductions that far exceeded Wall Street forecasts. The...
Roche’s oral SERD fails pivotal first‑line study — program setback
Roche disclosed that giredestrant missed the primary progression‑free survival endpoint in the PersevERA Phase 3 first‑line trial for ER‑positive, HER2‑negative metastatic breast cancer. The...
Ipsen pulls Tazverik from market after safety signal
Ipsen announced the voluntary withdrawal of Tazverik (tazemetostat) from the U.S. market and the suspension of ongoing studies after an independent monitoring committee identified cases of...
Sanofi inks $1.4B deal to in‑license China’s first‑in‑class JAK/ROCK
Sanofi agreed to in‑license rovadicitinib, a first‑in‑class dual JAK/ROCK inhibitor developed by Sino Biopharm that just secured approval in China, in a transaction valued north of $1.4 billion....
FDA clarifies leucovorin use — autism claims roll back
Federal regulators updated the status of leucovorin after high‑profile public statements suggested the drug could broadly benefit children with autism. The FDA approved high‑dose leucovorin for a...
Big biopharma backs South Korea — multi‑hundred‑million investments
Major international firms committed multiyear investments to strengthen South Korea’s biomedical sector. Roche pledged ₩710 billion (about US$485 million) over five years to expand clinical trial...
Servier buys Day One Biopharmaceuticals for $2.5B — rare‑cancer push
Servier agreed to acquire Day One Biopharmaceuticals for approximately $2.5 billion in cash, securing Day One’s pipeline focused on rare and pediatric cancers, including a lead program in...
FDA reopens review of DMD cell therapy as preclinical DMD work advances
The FDA has resumed review of Capricor Therapeutics’ previously rejected Duchenne muscular dystrophy (DMD) cell therapy after the company submitted additional clinical data. The agency’s decision...
Xenon’s epilepsy pill smashes Phase 3—FDA filing set
Xenon Pharmaceuticals reported a robust Phase 3 win for azetukalner in focal onset seizures, delivering placebo‑adjusted seizure reductions substantially above expectations. The company said it...
Vertex’s kidney drug clears Phase 3—accelerated approval bid begins
Vertex reported a Phase 3 victory for povetacicept in IgA nephropathy, meeting its primary endpoint and prompting the company to move quickly toward regulatory submission. Analysts flagged the...
Servier to buy Day One for $2.5bn—rare cancer pipeline expands
Servier agreed to acquire Day One Biopharmaceuticals in a transaction valued at about $2.5 billion, paying $21.50 per share in cash, the companies said. Servier said the acquisition will add Day...
BioNTech founders to exit—new mRNA spinout incoming
BioNTech confirmed that co‑founders Uğur Şahin and Özlem Türeci will leave the company by year‑end to launch a new venture focused on next‑generation mRNA therapeutics. BioNTech said it will grant...
Bristol Myers’ CELMoD mezigdomide clears Phase 3—myeloma program advances
Bristol Myers Squibb announced that mezigdomide, an oral CELMoD protein‑degrading agent, met its primary endpoint in a late‑stage trial for relapsed/refractory multiple myeloma, showing a...
Ipsen withdraws Tazverik after safety signal—market removal implemented
Ipsen announced an immediate market withdrawal of tazemetostat (Tazverik) following detection of secondary hematologic malignancies in a confirmatory trial, the company said. The decision halts...
Blackstone backs Teva with up to $400m—IBD antibody gets fuel
Teva Pharmaceuticals struck a growth capital deal with Blackstone Life Sciences for up to $400 million to advance duvakitug, a TL1A‑blocking monoclonal antibody in Phase III for inflammatory bowel...
Verily and Samsung link smartwatch data to trials—wearables move into endpoints
Verily and Samsung announced a partnership to integrate Galaxy smartwatch data into Verily’s Pre platform, creating an end‑to‑end system for deploying wearables in clinical studies and analyzing...
In vivo CAR T approaches escalate—industry bets on off‑the‑shelf engineering
A review of in vivo CAR T strategies highlights accelerating investment and early clinical signals as companies race to reprogram T cells inside the patient rather than ex vivo. Integrated viral...
AI tool accelerates synthetic routes—cheminformatics meets bench chemistry
Researchers unveiled an AI‑driven platform that streamlines chemical synthesis planning and accelerates drug candidate generation, reducing iterative medicinal chemistry cycles. The tool automates...