Curated news and analysis on clinical trials, drug approvals, and medical research.
Juvenescence, a clinical-stage AI-enabled biotech company, has appointed Eileen Jennings-Brown as Chief Technology Officer and established new research offices at Masdar City in Abu Dhabi to advance its longevity therapeutics pipeline.
ExCellThera's cell therapy Zemcelpro (dorocubicel) has been granted NUB Status 1 in Germany, allowing hospitals to apply for temporary supplementary reimbursement. 220 German hospitals have expressed interest in offering the therapy in 2026.
Artificial intelligence is advancing cancer care through early detection tools and improved clinical trial predictions. A Carnegie Mellon spinout is developing AI to identify high-risk patients, while predictive analytics are helping pharmaceutical companies prioritize promising compounds in oncology trials.
Eli Lilly announced positive Phase 3 LIBRETTO-432 trial results showing Retevmo (selpercatinib) significantly improved event-free survival in patients with early-stage RET fusion-positive non-small cell lung cancer as adjuvant therapy.
Novartis announced final Phase III ALIGN trial results showing Vanrafia (atrasentan) slowed kidney function decline in adults with IgA nephropathy, with a 2.39ml/min/1.73m² eGFR difference versus placebo at week 136.
Disc Medicine received a complete response letter from the FDA for bitopertin in erythropoietic protoporphyria, with the agency requesting Phase 3 APOLLO trial results before approval. The company expects to respond by mid-2027.
Gilead Sciences entered a definitive agreement to acquire Arcellx for $115 per share in cash plus a $5 contingent value right, representing an implied equity value of $7.8 billion. The acquisition provides Gilead with full control of anito-cel, an investigational BCMA-directed CAR T-cell therapy for multiple myeloma.
The FDA has accepted for filing the New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026.
Researchers used a machine-learning tool to analyze 500,000 UK Biobank participants, providing the first population-scale evidence that insulin resistance is a risk factor for 12 types of cancer.
The drug development services market is projected to reach $31.5 billion in 2026, growing at 12.2% CAGR, while AI-designed drugs enter pivotal Phase III trials that will determine whether the technology can improve clinical success rates beyond the industry's persistent 90% failure rate.
Nucleome Therapeutics announces Dr. Michelle Morrow as CSO effective February 23, 2026, bringing two decades of drug discovery experience as the company advances lead candidate NTP464 toward IND enabling studies.
Scientists in China report reversing Type 2 diabetes in a patient using stem cell therapy, while a separate study finds metformin may help women with diabetes live past 90. Both findings require larger trials.
DNA methylation-derived Protein EpiScores significantly improved prognostic accuracy for colorectal cancer survival when added to traditional clinical risk factors, raising concordance indices from 0.64 to 0.70 for disease-free survival and 0.70 to 0.75 for overall survival.
New data from LIBERTY studies show subcutaneous infliximab effectively restored and maintained disease control in Crohn's disease and ulcerative colitis patients after drug holiday of 16 weeks or more, with sustained efficacy through Week 102.
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
Tozaro, a Bedfordshire-based biotech company, has raised £6 million in funding led by Mercia Ventures to advance its Smart Polymer technology aimed at reducing the high production costs of cell and gene therapies.
Nicox SA received positive written feedback from a pre-NDA meeting with the FDA for NCX 470, a nitric oxide-donating bimatoprost eye drop for glaucoma. The NDA submission remains on track for summer 2026.
The Phase III MAJESTY study met its primary endpoint, showing significantly more people achieved complete remission at two years with Gazyva versus tacrolimus. If approved, Gazyva would be the first therapy specifically indicated for primary membranous nephropathy.
Roche announced positive Phase III MAJESTY trial results showing Gazyva achieved significantly higher complete remission rates at two years versus tacrolimus in primary membranous nephropathy, with no new safety signals identified.
Roche announced that Gazyva/Gazyvaro met its primary endpoint in the Phase III MAJESTY study for primary membranous nephropathy, showing statistically significant complete remission rates versus tacrolimus. The drug could become the first approved therapy for this rare autoimmune kidney disease.
