Curated news and analysis on clinical trials, drug approvals, and medical research.
Intravenous and subcutaneous nivolumab in advanced melanoma had similar safety profiles, with no major differences in systemic side effects. The main distinction was mild, manageable injection site reactions with subcutaneous administration.
Cellectar reported 12-month follow-up from the Phase 2b CLOVER WaM trial of iopofosine I 131 in relapsed or refractory Waldenström macroglobulinemia. In 55 patients, ORR was 83.6%, MRR was 61.8% and median duration of response was 17.8 months.
Neoadjuvant chemoimmunotherapy showed a 51.5% pathological complete response rate in 127 patients with resectable squamous cell lung cancer. Grade 3-4 treatment-related adverse events occurred in 11.8% of patients.
Cleveland Clinic, RIKEN and IBM used quantum and classical computers to simulate protein complexes spanning up to 12,635 atoms. The work builds on an earlier 303-atom Trp-cage simulation.
Cellectar Biosciences expanded its global IP estate and announced oversubscribed financing of up to $140 million. The funding supports iopofosine I 131 regulatory filings and a confirmatory study in Waldenström macroglobulinemia.
The U.S. vitamin market and the global sexual health supplement market are both forecast to grow, driven by preventive health, personalization and e-commerce. Market reports project vitamins reaching USD 22.72 billion by 2034 and sexual health supplements reaching $5.31 billion by 2030.
India said its 2021 rare disease policy expanded Centres of Excellence from 8 to 15 and raised financial assistance to Rs 50 lakh. But rare disease treatment can cost up to Rs 1 crore or more annually.
India is expanding rare disease support under the 2021 policy, with aid up to Rs 50 lakh and 15 Centres of Excellence. Officials also called for local innovation as treatment costs can reach ₹16 crore.
A JAMA Network Open study found high-dose vitamin D may reduce progression from prediabetes to type 2 diabetes in people with certain vitamin D receptor genotypes. In participants with ApaI CC or AC alleles, risk fell 19% versus placebo, while no reduction was seen in those with ApaI AA alleles.
Novartis introduced new long-term social impact and sustainability targets covering access, global health, emissions, waste and water. The plan includes a 2030 access goal and net-zero across the value chain by 2040.
Operation Stork Speed aims to update U.S. infant formula standards. An FDA report due this spring is expected to review contaminants, ingredients and new safety protocols.
Healthcare AI companies are making bold claims, but many have not brought treatments to market. One article said human testing remains the key measure, citing trial timelines, costs, and current programs.
FDA approval of daratumumab for high-risk smoldering multiple myeloma marks a shift from observation to early intervention. In a Phase II trial in earlier-stage disease, the overall response rate was 54% and the primary endpoint was not met.
Novartis finalized a seventh new US facility as part of a $23 billion expansion. The new API site in Morrisville, North Carolina, supports end-to-end US manufacturing across multiple therapy platforms.
The United Arab Emirates has unveiled two gene therapy projects targeting autism, epilepsy, and rare brain disorders in children. The initiatives focus on underlying genetic causes and earlier diagnosis.
Amylyx is approaching key catalysts ahead of its May 7 earnings report, led by Phase 3 LUCIDITY data for avexitide in post-bariatric hypoglycemia due in the third quarter. The company is also expected to provide updates on AMX0035 in Wolfram syndrome and AMX0114 biomarker data in ALS.
CVRx announced first-patient enrollment in the BENEFIT-HF trial, a 2,500-patient heart failure study across about 150 U.S. and German centers. The trial will evaluate all-cause mortality and heart failure decompensation events through 2032.
Risankizumab data in Crohn’s disease showed 55% clinical remission at week 12 in AFFIRM, durable efficacy through 148 weeks in SEQUENCE, and the lowest 24-month switch rate in a U.S. claims analysis.
Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
Alnylam reported full-year 2025 profitability and $2.987 billion in global net product revenues, driven by U.S. approval and growth of AMVUTTRA. The company also outlined 2026 pipeline goals and additional HELIOS-B analyses for vutrisiran.
