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Regulatory approval - IgA nephropathy
The FDA granted accelerated approval to Vera Therapeutics’ TRUTAKNA (atacicept-vymj) for adults with primary IgA nephropathy (IgAN) at risk for disease progression, targeting proteinuria...
Late-stage oncology efficacy - resected ALK-positive NSCLC
In a phase 3 trial in resected ALK-positive non-small-cell lung cancer (NSCLC), ensartinib markedly improved disease-free survival versus placebo. The study enrolled patients with completely...
Large-cap M&A - Vertex expands into endocrinology
Vertex Pharmaceuticals agreed to acquire Crinetics Pharmaceuticals in a $10 billion cash deal, expanding Vertex’s commercial pillars beyond cystic fibrosis and deep into endocrine rare diseases....
Gene editing dispute - Prime vs Beam
Prime Medicine said an arbitration panel found in its favor in a dispute with Beam Therapeutics over a 2019 gene-editing agreement. The decision clears the way for Prime to continue development of...
Clinical trial - DMD with AAK1 inhibitor
Satellos Bioscience released interim results from its adult phase 2 Trailhead study of SAT-3247, an oral AAK1 inhibitor, in Duchenne muscular dystrophy (DMD). The company provided a six-month data...
Clinical trial - cell therapy transplant conditioning
Boston Children’s Hospital and Dana-Farber Cancer Institute researchers reported an approach aimed at reducing the toxicity of hematopoietic stem cell transplants by replacing conventional...
Cell therapy development - local PBMC processing
OrganaBio opened a new PBMC isolation and cryopreservation facility in San Diego at Excellos Labs, targeting a key preclinical-to-clinical bottleneck for autologous cell therapy programs. The...
Oncology diagnostics/biomarkers - rapid molecular testing partnership
Biocartis and Discovery Life Sciences expanded their precision oncology collaboration to deliver faster biomarker testing and improve clinical trial enrollment workflows. The companies will...
FDA policy - releasing rejection letters
The FDA paused a policy that would proactively release drug rejection letters as the agency works to formalize the approach via rulemaking. The halt follows a citizen’s petition submitted by an...
Biomanufacturing - continuous bioprocessing interface barriers
Research highlighted that the biggest technical barrier to end-to-end continuous biomanufacturing is often not the lack of continuous unit operations, but interface mismatches between steady...
Regulatory approval — IgA nephropathy
The U.S. FDA cleared Vera Therapeutics’ Trutakna (atacicept) for immunoglobulin A nephropathy (IgAN) with an accelerated approval based on proteinuria reduction. The clearance makes Trutakna the...
Regulatory policy — FDA rejection letter rule paused
The FDA paused a controversial policy to proactively release drug rejection letters while it moves to formalize the underlying approach. The halt follows a citizen’s petition from an unnamed...
Big Pharma partnerships — AstraZeneca and Sino Biopharm respiratory bets
AstraZeneca and GSK doubled down on China collaborations with Sino Biopharmaceuticals via separate respiratory deals. AstraZeneca is licensing an ex-China PDE3/4 inhibitor candidate, while GSK is...
Biopharma M&A — Vertex acquires Crinetics for endocrinology expansion
Vertex agreed to buy Crinetics Pharmaceuticals for $10 billion in cash, its largest-ever acquisition, expanding the company beyond cystic fibrosis and adding an endocrinology platform. Crinetics’...
Biopharma deals — Novartis buys Myricx Bio to scale ADC payloads
Novartis agreed to acquire Myricx Bio for up to $1.5 billion, aiming to strengthen its oncology pipeline with a next-generation antibody-drug conjugate payload platform. Myricx’s...
Gene editing disputes — Prime Medicine arbitration win vs Beam
Prime Medicine said it won arbitration against Beam Therapeutics in a contract dispute over gene-editing technology used in an alpha-1 antitrypsin deficiency program. Arbitrators determined...
Clinical pipeline — Satellos Duchenne interim readout and next steps
Satellos disclosed six-month interim data from its adult Phase II Trailhead study of SAT-3247 in Duchenne muscular dystrophy. The company reported improvements in muscle fat fraction and effort...
Cell therapy — safer conditioning via epitope-edited donor stem cells
Researchers from Boston Children’s Hospital and Dana-Farber Cancer Institute reported an approach for hematopoietic stem/progenitor cell transplants that aims to replace genotoxic conditioning....
Manufacturing and regulatory execution — FDA PreCheck pilot for facility inspections
Fujifilm Biotechnologies’ Holly Springs, North Carolina cell culture site was selected for the FDA’s PreCheck Pilot Program, a facility-inspection and engagement initiative intended to reduce...
Discovery and translational science — structured alternatives in AI-guided biology
Northeastern University researchers, working with the Parallel Squared Technology Institute, reported in Nature a large-scale mapping of alternate RNA translation events producing roughly 1,700...