News archive.
Earlier AI news and analysis, kept for reference. Current coverage lives in News & Analysis.
NICE backs Aquipta for acute migraine in UK, expanding treatment options
AbbVie's atogepant gains NHS approval for adults who failed at least two triptans. Eligible patients in England and Wales can now access the oral treatment on the health service.
Connecta Starts Phase 2a Trial of Neuroplasticity Drug for Fragile X
Connecta Therapeutics has enrolled 30 adult males in a trial of CTH120, a TrkB-targeting small molecule designed to restore neuronal function in fragile X syndrome, the most common inherited cause of intellectual disability.
Anocca doses first pancreatic cancer patients with KRAS-targeting TCR-T therapy
Anocca has dosed the first patients in phase 1 of VIDAR-1, testing ANOC-001, a precision T-cell therapy targeting KRAS G12V mutations in pancreatic cancer. The trial spans eight university hospitals across Sweden, Denmark, Germany, and the Netherlands.
NICE approves daratumumab quadruplet for transplant-ineligible myeloma patients
England and Wales will fund D-VRd (daratumumab with bortezomib, lenalidomide, dexamethasone) for newly diagnosed multiple myeloma patients who cannot receive stem cell transplants. The CEPHEUS trial showed 60.9% minimal residual disease-negativity versus 39.4% for triplet alone.
Clinical trial screening that reads patient notes, not just checkboxes
Paradigm Health's LLM-based tool analyzes unstructured patient data to surface eligibility misses and explain why each patient matches or doesn't. CRCs get faster, more transparent screening decisions.
Parabilis raises $670M in biggest biotech IPO ever
Parabilis Medicines closed a $670M IPO on Nasdaq, breaking the biotech record set two months prior. The cancer-therapy company's Helicon peptides target proteins previously unreachable by drugs.
EMA validates Bayer's stroke drug asundexian for post-stroke prevention
Bayer's Factor XIa inhibitor asundexian cleared regulatory review in Europe after Phase III trial showed 26% reduction in ischaemic stroke. FDA and China also granted priority review.
Beren pockets $300M for rare disease therapy push
Beren Therapeutics raised $300M in combined funding to launch adrabetadex for infantile Niemann-Pick disease, pending FDA approval. The company plans local care sites and patient support infrastructure.
XtalPi lands $400M drug-design deal using quantum AI for metabolic targets
$400M partnership with undisclosed pharma company. XtalPi will use quantum physics and AI to design oral small-molecule GPCR therapeutics. Pilot phase showed improved hit rates on a notoriously difficult target.
In Silico Models Speed Antibody Design Before Lab Work
BigHat Biosciences presented evidence that computational tools can screen antibody mutations faster than physical experiments, reducing manufacturability risks early in development. Here's what that means for drug makers.
Symeres Adds Spray Drying to New Jersey CMC Site for Hard-to-Dissolve Drugs
Symeres expanded spray drying at its Cranbury, NJ facility to support formulation development for poorly soluble compounds from preclinical through Phase II trials. The capability combines ASDs, particle engineering, and process development in one location.
Brain Aneurysm Study Maps 19 Cell Types Tied to Rupture Risk
Researchers analyzed 100,000+ cells from human aneurysms and identified macrophage and fibroblast patterns that predict which aneurysms will rupture—potentially enabling earlier intervention.