Latest Biotech News

Regeneron committed up to $2.3 billion to Parabilis Medicines to develop antibody–Helicon conjugates aimed at intracellular targets described as “historically undruggable.” The collaboration...

Relay Therapeutics reported a Phase 2 efficacy signal for its isoform-selective PI3Kα inhibitor zovegalisib (RLY-2608) in patients with PIK3CA-driven vascular anomalies. The company said the trial...

Vincentage Pharma reported that its once-daily oral small-molecule GLP-1 receptor agonist VCT-220 met primary endpoints in a pivotal Phase 3 trial in overweight or obese patients in China. The...

Create Medicines secured $122 million in a Series B to fund therapies that express CARs in patients’ cells using mRNA delivered via liquid nanoparticles. The company expects the cash to last...

The FDA proposed a “Plausible Mechanism Framework” as an alternative evidence pathway for individualized and disease-targeted therapies when standard randomized trials may be impractical. BIO said...

Diasorin’s Liaison Plex Flex assay was cleared for clinical use as a multiplex gastrointestinal pathogen PCR panel covering 24 bacteria, viruses, and parasites. The assay’s modular Flex software...

The European Medicines Agency proposed a centralized contract support platform and clinical trial contract templates to address persistent start-up delays across Europe. In its clinical trial...

BioMarin’s Phase 3 program for a rare inherited enzyme deficiency drug (from its Inozyme Pharma acquisition) missed the mark, meeting only one of two primary goals. The company’s results were...

Regeneron struck a major research collaboration with Parabilis Medicines to develop antibody–peptide conjugates built around Parabilis’ Helicon platform. The pact centers on five undisclosed...

Relay Therapeutics reported a Phase 2 efficacy signal for zovegalisib (RLY-2608) in patients with PIK3CA-driven vascular anomalies, delivering a 60% volumetric response that exceeded expectations...

The FDA approved AstraZeneca’s baxdrostat (Baxfendy), a first-in-class aldosterone synthase inhibitor, for hypertension in combination with other antihypertensive medications for patients whose...

BioMarin’s Phase 3 program for its ENPP1 deficiency therapy landed below regulatory expectations, missing a key goal in a rare inherited enzyme deficiency study. The results add uncertainty around...

EpiCypher expanded its commercialization partnership with New England Biolabs to broaden epigenomics tool development and distribution. The companies are extending their workflow collaboration...

Nature published new work on Robin, a multi-agent system designed to automate the scientific discovery loop for experimental biology. The system integrates literature-search agents with...

Delfi Diagnostics presented interim clinical utility data for its cfDNA-based FirstLook Lung blood test in a cluster-randomized FIRSTLUNG study. The company reported that access to the assay...

Create Medicines closed a $122 million Series B financing to support its pipeline of in vivo CAR therapies delivered by liquid nanoparticles. The company said the funding runway is expected to...

The European Medicines Agency proposed a centralized approach to help harmonize and speed clinical trial contracts across Europe. In its clinical trial highlights newsletter, EMA said stakeholders...

Helio Genomics expanded commercialization for its HelioLiver blood-based liver cancer screening test by partnering with Syneos Health. The companies said the deal is intended to broaden adoption...

The European Medicines Agency (EMA) proposed a centralized support platform to standardize clinical trial contracting across the EU, aiming to reduce delays that sponsors face when negotiating...

The FDA cleared Diasorin’s customizable syndromic GI multiplex PCR panel, expanding the LIAISON Plex Gastrointestinal Flex Assay menu. The test detects 24 pathogens—bacteria, viruses, and...