Curated news and analysis on clinical trials, drug approvals, and medical research.
India has eased Press Note 3 FDI rules with a beneficial ownership test, 10% safe harbour for non-controlling LBC investments, and 60-day fast-track approvals in seven manufacturing sectors. The revised norms aim to clear 600 pending applications and boost gross FDI to $90 billion in FY26.
FDA's ODAC voted 6-3 against AstraZeneca's camizestrant for HR+/HER2- metastatic breast cancer, citing uncertain clinical benefit from the SERENA-6 trial design. The FDA raised concerns about the early-switch treatment paradigm and long-term outcomes.
Ray Therapeutics received EMA PRIME designation for its RTx-015 optogenetic gene therapy for retinitis pigmentosa, following recent FDA RMAT status. The company also appointed Michael Murtagh as Chief Regulatory Officer to support global development.
Crescent Biopharma dosed the first patient in its ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody for solid tumors. The company also reported Q1 2026 results and outlined pipeline milestones including ADC combination trials expected in the second half of 2026.
Researchers identify DPY30 as an epigenetic target to sensitize pancreatic tumors to immunotherapy. UC San Diego researchers redirect CMV immunity against pancreatic cancer in preclinical models. A Fred Hutch researcher receives ACS grant to study immunotherapy resistance in melanoma.
MIT chemical engineers used a large language model to optimize protein production in industrial yeast. The AI model improved yields for five of six tested proteins, including a cancer monoclonal antibody, potentially reducing drug development costs.
FDA issued guidance on the Food Traceability Rule, finalized an exemption for IMS-listed Grade A cottage cheese, and announced a June 15, 2026 public meeting on lot-level traceability, as Congress bars enforcement funding until July 20, 2028.
EMA has initiated a rolling review of OS Therapies' OST-HER2 for preventing recurrence in fully resected pulmonary metastatic osteosarcoma. A potential conditional marketing authorization decision is expected in Q4 2026, with a confirmatory Phase 3 trial planned for Q3 2026 in Australia.
FDA clears Cloudbreak Pharma's IND for CBT-199, a novel presbyopia eye drop, allowing Phase 2 trials to proceed. The company also advances CBT-001 (Phase 3 for pterygium) and CBT-004 (Phase 3 for pinguecula).
Two studies show liquid biopsy can predict immunotherapy response in HER2-negative breast cancer and identify which patients with relapsed germ cell tumors may benefit from high-dose chemotherapy, advancing precision oncology.
Experts discuss balancing efficacy and safety in BTK inhibitor plus venetoclax combination therapy for CLL, including BTK lead-in strategies to reduce tumor lysis syndrome risk and the benefits of all-oral fixed-duration regimens.
A phase 3 trial of an mRNA H5N1 bird flu vaccine is recruiting 4,000 volunteers in the UK and US. The Moderna-sponsored study aims to assess immune responses against emerging strains as the virus continues to evolve in mammals.
GeoVax is advancing Gedeptin toward a Phase 2 trial in head and neck cancer and has secured an exclusive license from Emory University for Gedeptin-ICI combination technology. The therapy has Orphan Drug Designation for oral and pharyngeal cancers.
Immunome submitted an NDA to the FDA for varegacestat in desmoid tumors after the Phase 3 RINGSIDE trial showed an 84% reduction in progression risk (HR=0.16) and a 56% objective response rate. The company plans to file in Q2 2026.
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Q4 earnings were mixed across 17 tracked pharmaceutical companies. Elanco and ANI Pharmaceuticals beat revenue estimates, while Corcept and Amphastar missed. The XPH pharma ETF posted a 29% one-year return but significantly lagged the S&P 500 over five and ten years.
Single-cell RNA sequencing of nearly 92,000 cells from the DESTINY-Gastric06 trial reveals distinct primary and acquired resistance mechanisms to trastuzumab deruxtecan in HER2-positive gastric cancer, including MUC3A and CST3 as key drivers.
FDA approves AstraZeneca's Breztri Aerosphere as the first single-inhaler triple therapy for asthma in patients aged 12+, based on Phase III KALOS and LOGOS trials showing improved lung function and reduced exacerbations versus dual therapy.
Compass Therapeutics reported mixed Phase 2/3 data for tovecimig in biliary tract cancer and plans to meet with the FDA for a BLA discussion. The study met its primary ORR endpoint (17% vs 5%), while PFS and OS data are due late this quarter.
