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Vertex claims best-in-class IgAN win — FDA filing imminent
Vertex reported a positive Phase 3 Rainier readout for povetacicept, a dual BAFF/APRIL inhibitor, and is moving to file a Biologics License Application with the U.S. Food and Drug Administration....
Xenon’s epilepsy pill delivers knockout Phase 3 data — filing ahead
Xenon Pharmaceuticals announced top-line Phase 3 results for azetukalner showing large, statistically robust reductions in focal onset seizure frequency versus placebo and plans an FDA filing...
BioNTech founders to exit and form next‑gen mRNA startup
BioNTech co‑founders Ugur Sahin and Özlem Türeci announced plans to step down by the end of the year to create a new company focused on next‑generation mRNA therapeutics. BioNTech will grant the...
Sandoz spins out biosimilars unit — regulators ease biosimilar testing rules
Sandoz announced the creation of a standalone biosimilars division, appointing Armin Metzger to lead development, manufacturing and supply as the company positions to capture a wave of patent...
Ipsen pulls Tazverik after safety signal — trials and sales halted
Ipsen announced an immediate market withdrawal of Tazverik (tazemetostat) and the suspension of ongoing trials after an independent data monitoring committee reported cases of secondary...
Roche’s oral SERD flunks first‑line trial — competitors and partners take hits
Roche disclosed that giredestrant failed to meet the primary progression‑free survival endpoint in a pivotal first‑line Phase 3 study, disappointing expectations for an oral SERD that had earlier...
Peptide and CDMO capacity grows — Neuland ramps peptides, Lonza reshapes portfolio
Neuland Laboratories said the first module of a new commercial peptide manufacturing facility at its Bonthapally campus will be operational this summer, offering multi‑kiloliter LPPS and SPPS...
Big pharma M&A and capital deals move pipelines — Servier, Teva score major funding
Servier announced a $2.5 billion cash acquisition of Day One Biopharmaceuticals to add rare oncology programs, including pediatric low‑grade glioma candidates, strengthening its rare‑cancer...
Regulators move to speed emergency studies — U.S. broadens access, FDA widens label use
The European Medicines Agency proposed draft rules to fast‑track clinical trial approvals during declared public health emergencies, encouraging sponsors to coordinate with the EMA’s Emergency...
CAR T innovation: biomimetic enhancers and in‑vivo strategies race to scale
Researchers unveiled a ferritin‑based biomimetic platform (FACE) that augments CAR T cell avidity ex vivo and improves tumor cell engagement in refractory leukemia models without altering CAR...
Vertex races to FDA after Phase‑3 kidney win
Vertex reported a positive phase 3 readout for povetacicept in immunoglobulin A nephropathy (IgAN) and is advancing regulatory filings. The company said the trial met its primary endpoint with a...
BioNTech founders to spin out next‑gen mRNA company
BioNTech co‑founders Ugur Sahin and Özlem Türeci announced they will step down and launch a new startup focused on next‑generation mRNA innovations. BioNTech said the pair will leave by year‑end...
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...