Latest Biotech News

Roche has ended two Huntington’s disease antisense therapy programs co-developed with Ionis after failing to meet key objectives and encountering a safety signal. The company discontinued the...

The FDA has returned to releasing pharma rejection letters (CRLs), posting 14 new complete response letters online after a brief pause. The agency framed the shift around a renewed emphasis on...

The UK’s drug pricing and reimbursement watchdog has issued draft guidance recommending stopping National Health Service funding for Amgen’s Lumakras for new patients. The move, reported after the...

Germany’s lawmakers have voted to advance a cost-saving healthcare bill that would more than double mandatory manufacturer rebates on most brand prescription drugs from 7% to 15.5%. The...

GSK reported that its B7-H3-targeted antibody-drug conjugate risvutatug rezetecan (risvutatug rezetecan; ris-rez) met the primary endpoint in a Phase 3 study in China for advanced or relapsed...

Apnimed has filed for an initial public offering after years of delay, as the company moves forward while the FDA reviews its sleep apnea program. The report describes the Nasdaq move following a...

CARB-X, working with the Center for Global Development, is advancing NeoTest—an effort designed to accelerate the development and uptake of point-of-care diagnostics for neonatal sepsis. The...

A Phase 1/2 open-label trial in Parkinson’s disease has reported feasibility and early safety for STEM-PD, a cryopreserved, off-the-shelf dopaminergic progenitor derived from human pluripotent...

McKinsey says biopharma companies won’t capture AI’s full upside unless they reorganize R&D around a closed-loop decision process instead of traditional stage gates. The report argues that AI can...

ARPA-H has announced THRIVE, a up-to-$160 million, up to five-year program designed to accelerate bespoke in vivo gene editing therapies for rare diseases. The effort will back seven teams across...

Roche ended two Huntington’s disease antisense programs with Ionis Pharmaceuticals after disappointing clinical outcomes, adding to a run of recent setbacks for neurodegeneration assets. In a...

The FDA resumed publishing complete response letters (CRLs) after a pause designed to support “commitment to transparency,” according to BioCentury coverage and related FDA postings. The resumed...

ARPA-H launched THRIVE, a multi-team, up-to-$160 million effort intended to accelerate bespoke gene-editing therapies for rare genetic pediatric diseases. The program, announced by the U.S. health...

New Nature Biotechnology research reported online July 10 describes in vivo cytosine base editing enhancements using virus-like particles combined with uracil DNA glycosylase inhibition. The study...

Freenome reported clinical validation results for an updated version of its SimpleScreen CRC blood test for colorectal cancer, including performance against previously collected colonoscopy-linked...

A new study in Cell Death Discovery identified PRMT6 as a driver of blood vessel growth in colorectal cancer, linking the protein-arginine methyltransferase to angiogenesis mechanisms that can...

MIT and Samsung reported an advance aimed at extending the longevity and energy efficiency of quantum dot light-emitting diodes used in displays and lighting. The work centers on improving...

Biohaven is mentioned in multiple deal-and-operations reporting items tied to competitive reshuffling in neuro/rare disease portfolios. In the latest “Deals, deals, deals” wrap, Endpoints...

A wave of late-breaking translational and operational moves highlighted the scaling requirements for cell and genetic medicine development. On the trial pipeline side, multiple stem-cell and...

Bausch + Lomb discontinued its glaucoma eye-drop candidate BL1107 after a Phase 2 trial missed primary and secondary endpoints. The company had been evaluating the alpha-2B agonist in patients...