Get the Daily Brief
Latest Biotech News
Vertex races to FDA: BLA filed after Phase III win
Vertex Pharmaceuticals reported pivotal late-stage success for povetacicept and has filed a Biologics License Application (BLA) targeting accelerated approval for immunoglobulin A nephropathy...
Xenon’s Kv7 drug shocks epilepsy field — Phase III clears primary goal
Xenon Pharmaceuticals reported that azetukalner, a Kv7 potassium channel opener, met the primary endpoint in the Phase III X‑TOLE2 study for focal onset seizures and will pursue an NDA filing...
BioNTech founders depart: next‑gen mRNA spinout in the works
BioNTech co‑founders Ugur Sahin and Özlem Türeci announced plans to step down and form a new startup focused on next‑generation mRNA therapeutics, while BioNTech will retain a minority stake and...
UHS buys Talkspace for $835M — virtual care scales into hospital network
Universal Health Services agreed to acquire virtual behavioral health platform Talkspace for $835 million, aiming to integrate 6,000 clinicians and a large teletherapy footprint into UHS’s...
Ipsen withdraws Tazverik amid safety signal — company halts trials and sales
Ipsen voluntarily pulled the EZH2 inhibitor Tazverik (tazemetostat) from the U.S. market and halted ongoing clinical studies following independent monitoring that identified secondary hematologic...
Sandoz splits off biosimilars unit — firm bets on coming patent cliff
Sandoz announced the creation of a standalone biosimilars unit led by Armin Metzger, separating biologic follow‑on development, manufacturing and supply from its small‑molecule generics business....
Neuland expands peptide capacity — commercial module to open this summer
CDMO Neuland Laboratories said its new commercial peptide production facility at Bonthapally, India, will open its first module this summer, adding multi‑kiloliter SPPS and LPPS capacity to...
Biomimetic ‘FACE’ boosts CAR‑T potency without re‑engineering cells
Researchers introduced a ferritin aggregation cell engager (FACE) that enhances CAR‑T efficacy against refractory leukemias by bridging CAR‑T cells and tumor cells via CD71, improving avidity...
EMA moves to speed trial approvals in emergencies — draft rules released
The European Medicines Agency issued draft guidance proposing accelerated trial approvals during public health emergencies, urging sponsors to prioritize well‑designed, multi‑site clinical trials...
Cirena licenses long‑RNA synthesis tech from CU Boulder — enables ultra‑long constructs
Cirena secured an exclusive license to the University of Colorado Boulder’s thionocarbonate‑based RNA synthesis platform, enabling reliable production of long RNAs (~100–400 nt) with higher yields...
Xenon’s Kv7 data stun markets – Seizure drug headed for FDA filing
Xenon Pharmaceuticals reported compelling Phase III results for azetukalner, a Kv7 potassium-channel opener, showing a large placebo‑adjusted reduction in focal onset seizure frequency. The...
Vertex races to FDA – IgA nephropathy drug eyes accelerated pathway
Vertex Pharmaceuticals reported positive Phase III Rainier data for povetacicept, its dual BAFF/APRIL inhibitor acquired in a takeover, and is preparing a biologics license application intended...
BioNTech founders exit to launch next‑gen mRNA startup
BioNTech co‑founders Ugur Sahin and Özlem Türeci announced plans to leave the company by year‑end to found a new firm focused on next‑generation mRNA technologies. BioNTech will grant the spin‑out...
Sandoz doubles down on biosimilars – Dedicated unit to capture patent cliff
Sandoz announced the creation of a standalone biosimilars business unit and named Armin Metzger to lead development, manufacturing and supply as the company targets an expected decade of biologic...
EMA drafts faster trial approvals for health emergencies
The European Medicines Agency issued draft guidelines proposing accelerated study authorization during public‑health emergencies, urging sponsors to work with the EMA’s Emergency Task Force to...
Ipsen pulls Tazverik after safety alarm – Market access and trials halted
Ipsen announced the withdrawal of Tazverik (tazemetostat) and the suspension of ongoing studies after an independent data monitoring committee identified cases of secondary hematologic...
Roche’s breast cancer pill fails pivotal test – Competitors react
Roche disclosed that giredestrant missed its primary progression‑free survival endpoint in a Phase III PersevERA study as first‑line therapy for ER‑positive, HER2‑negative metastatic breast...
FDA widens leucovorin label — White House claims collide with regulator
The U.S. FDA approved an expanded indication for leucovorin to treat cerebral folate deficiency linked to FOLR1 variants, but the agency explicitly stopped short of endorsing the vitamin for broad...
Big pharma doubles down in South Korea — $1bn+ in new commitments
Roche pledged ₩710 billion (about $485 million) and Eli Lilly committed $500 million to expand biopharma investment in South Korea over five years, signaling intensified industry focus on the...
Novo and Hims strike peace — GLP‑1 distribution deal ends feud
Novo Nordisk and Hims & Hers reached an agreement for Hims to sell Novo’s GLP‑1 weight‑loss and diabetes medicines on its telehealth platform at standard prices and to limit promotion of...