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Neurodegeneration collaboration collapse
GSK has notified Alector that it is ending their immuno-neurology alliance, following major clinical setbacks for both investigational programs. The companies’ pact, struck in 2021 and scaled with...
Gene editing funding push
ARPA-H launched THRIVE, a planned up-to-$160 million effort to develop custom gene editing treatments across rare diseases. The program will fund seven different teams, each with a stated...
FDA transparency policy shift on CRLs
The FDA has paused releasing new publicly available complete response letters (CRLs), seeking to reduce litigation risk around disclosure of sensitive rejection details. The pause follows a...
Parkinson’s stem cell trial results
STEM-PD reported first human data supporting the feasibility and safety of an off-the-shelf stem cell approach for Parkinson’s disease. In the Phase 1/2 open-label trial, eight participants in...
IgA nephropathy approval
Vera Therapeutics won U.S. accelerated approval for TRUTAKNA (atacicept-vymj) to treat adults with primary IgA nephropathy at risk of disease progression. The FDA decision is based on an interim...
Immuno-oncology diagnosis platforms get regulatory validation
Natera’s Signatera MRD test received certification under the EU’s IVDR framework for multiple cancers. The certification covered the assay platform components, including specimen collection kit...
Respiratory licensing deal
AstraZeneca struck a licensing agreement with Sino Biopharmaceutical for ex-China rights to TQC3721, a dual PDE3/4 inhibitor candidate aimed at chronic obstructive pulmonary disease. AstraZeneca...
Cell therapy startup deepens execution infrastructure
OrganaBio opened a local PBMC processing and cryopreservation lab in San Diego to compress the time from leukapheresis to frozen product for autologous cell therapies. The workflow is designed to...
Biopharma manufacturing regulatory readiness program
Fujifilm Biotechnologies said its Holly Springs, North Carolina cell culture facility was selected for the FDA’s PreCheck Pilot Program. The initiative is designed to improve early interaction...
Rare disease biotech merger for precision immunology in RA
Chemolab Therapeutics and Scipher Medicine agreed to merge and rebrand as Scipher Medicine Corporation, focusing initially on advancing nebokitug, an anti-CCL24 monoclonal antibody for rheumatoid...
AI-designed peptides that predict receptor activity
University of Pennsylvania researchers and The Chinese University of Hong Kong presented TD3B, an AI framework aimed at streamlining peptide drug design. The system generates peptide candidates...
Rheumatoid arthritis precision immunology merger and phase 2 plan
Chemolab Therapeutics and Scipher Medicine announced plans to merge and rebrand as Scipher Medicine Corporation, positioning the combined company to advance nebokitug toward a phase 2 trial in...
FDA accelerated approval for first-in-class BAFF/APRIL IgA nephropathy drug
The FDA granted accelerated approval to Vera Therapeutics’ Trutakna (atacicept-vymj) for adults with primary IgA nephropathy (IgAN) at risk for progression, according to the company. Trutakna is...
Heart disease trial failure deepens competitive pressure in ATTR cardiomyopathy
AstraZeneca said its heart disease drug Wainua, developed with Ionis Pharmaceuticals, failed to outperform placebo in a pivotal trial in transthyretin-mediated amyloidosis cardiomyopathy...
Megadeal reshapes rare endocrinology portfolio with Crinetics
Vertex Pharmaceuticals agreed to acquire Crinetics Pharmaceuticals for about $10 billion in cash, marking the largest deal in Vertex’s history and expanding the company beyond cystic fibrosis....
Drug makers chase speedier trials under HHS Operation Trialblazer
HHS unveiled Operation Trialblazer, a federal plan intended to speed up early drug research by modernizing regulatory processes across multiple agencies, including FDA and NIH. The blueprint is...
FDA pauses release policy for complete response letters (CRLs)
The FDA paused a controversial policy of releasing complete response letters (CRLs) that describe its rationale for rejection, according to coverage. The pause is tied to efforts to formalize the...
Prime clears gene-editing dispute and eyes AATD trial restart
Prime Medicine said an arbitration panel ruled in its favor in a gene-editing dispute with Beam Therapeutics, concluding Prime did not violate a 2019 agreement tied to competing development. The...
AstraZeneca accelerates respiratory position with Sino PDE3/4 licensing
AstraZeneca agreed to license Sino Biopharmaceutical’s investigational dual PDE3/4 inhibitor TQC3721 for ex-China rights in a deal worth up to $2.1 billion. Sino’s subsidiary Chia Tai Tianqing...
EU-linked diagnostic certification for Natera’s Signatera MRD in multiple cancers
Natera said its Signatera minimal residual disease (MRD) test platform received certification under the EU In Vitro Diagnostic Regulation (IVDR) for multiple cancers. The platform review included...