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Xenon’s epilepsy pill exceeds expectations – files to follow
Xenon Pharmaceuticals reported a strong Phase 3 outcome for azetukalner in focal onset seizures, exceeding analysts’ expectations and producing a materially larger placebo‑adjusted seizure...
Novo and Hims end feud — GLP‑1 distribution deal struck
Novo Nordisk and telehealth firm Hims & Hers reached an agreement under which Hims will sell Novo’s GLP‑1 obesity and diabetes medicines on its platform and curb promotion of compounded...
EMA proposes faster trial approvals during public‑health emergencies
The European Medicines Agency issued draft guidance to accelerate clinical trial authorizations during public‑health emergencies. The proposals would streamline approvals for studies relevant to...
Biocartis wins IVDR nod for automated MSI colorectal companion test
Biocartis obtained EU In Vitro Diagnostic Regulation (IVDR) Class C certification for its Idylla CDx MSI cartridge, clearing a regulatory hurdle for use across Europe. The automated PCR test...
Neuland moves into commercial peptide manufacturing as demand surges
CDMO Neuland Laboratories announced module one of a new commercial peptide plant at its Bonthapally campus will be operational by summer, adding thousands of liters of SPPS and LPPS reactor...
China’s biotechs race to build low‑cost rivals to $2M gene therapy
Several Chinese companies are developing lower‑cost gene therapies intended to compete with Novartis’ one‑time spinal muscular atrophy drug, Zolgensma, which costs roughly $2.1 million per dose....
FDA trims foreign comparator testing in draft biosimilar guidance
The U.S. Food and Drug Administration issued a revision to draft guidance easing certain clinical pharmacokinetic testing requirements for biosimilars that use comparator biologics approved...
Ipsen withdraws Tazverik after safety monitors flag secondary cancers
Ipsen announced a voluntary withdrawal of the oncology drug Tazverik (tazemetostat) following an independent data monitoring committee’s identification of secondary hematologic malignancies in a...
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...