Curated news and analysis on clinical trials, drug approvals, and medical research.
A comparative study found Canadian patients waited more than 90 weeks longer than Americans and 65 weeks longer than Europeans for new drugs approved between 2019 and 2025. The report said late submissions to Health Canada, along with price controls and other market factors, were the main drivers.
The FDA finalized a framework for reviewing food chemicals already on the market and launched assessments of BHT and ADA. Public comments on both reassessments are open until July 13, 2026.
The FDA has accepted Ascelia Pharma's NDA for Orviglance, a manganese-based oral MRI contrast agent for liver imaging in patients with severe kidney impairment, and set a PDUFA action date of July 3, 2026.
Acrivon Therapeutics said its wholly owned laboratory in Watertown received Massachusetts CLIA certification with a full license to conduct patient testing and develop companion diagnostics. The company said the lab is expected to be fully operational in the first half of 2026 and will support targeted therapeutics development.
Pfizer reported positive Phase II data for PF-07872412, a 25-valent pneumococcal conjugate vaccine candidate in infants. Serotype 3 geometric mean titers were 8.8-fold higher after dose three and about 15-fold higher after dose four versus PREVNAR 20.
Sentante secured CE-mark approval for its multi-domain robotic platform and was accepted into the FDA’s total product life cycle advisory programme. The moves support European commercialization and planning for remote stroke thrombectomy clinical studies.
Trump’s Most Favoured Nation drug pricing plan would tie some U.S. drug prices to lower foreign prices. The source articles say the policy could delay launches in Canada, raise Canadian prices and affect R&D decisions.
Tent5a was identified as a positive regulator of insulin production in pancreatic beta cells. Overexpression extended poly(A) tails of insulin transcripts and increased insulin content.
A systematic review and meta-analysis found high infection rates with teclistamab in relapsed/refractory multiple myeloma. Five studies showed pooled infection rates of 56.5% for any grade and 27.6% for grade 3 or higher.
The FDA approved Novocure’s Optune Pax, a wearable tumor-treating fields device, for pancreatic cancer in combination with chemotherapy. Phase III PANOVA-3 data showed delayed pain progression and improved one-year overall survival in inoperable locally advanced disease.
Bristol Myers Squibb will deploy Anthropic’s Claude across global operations, putting the AI platform in the hands of more than 30,000 employees. BMS plans to use it in R&D, clinical development, manufacturing and commercial work.
ImmunityBio said the FDA accepted its sBLA for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease. The PDUFA date is Jan. 6, 2027.
Estrogen-only hormone replacement therapy after risk-reducing bilateral oophorectomy was associated with lower breast cancer risk in women with BRCA1 pathogenic variants. In 919 women followed for an average of 8.8 years, incident breast cancer was lower among HRT users than nonusers.
An experimental study found remote ischemic conditioning protected the heart during anthracycline treatment in tumor-bearing mice without reducing antitumor efficacy. The work supports the ongoing RESILIENCE clinical trial in cancer patients.
Cinclus Pharma said its first Phase III study is nearing full enrollment, with topline results expected in the fourth quarter of 2026. The company also reported regulatory progress for linaprazan glurate and a EUR 28 million financing agreement.
The FDA fast-tracked an inhalable gene therapy for advanced lung cancer after an early 11-patient trial showed tumour shrinkage in three patients and disease stabilization in five. Larger studies involving about 250 patients are underway.
Cell and Gene Therapy Catapult has established a Technology Advisory Board to support technology deployment across advanced therapies. The board will focus on data, manufacturing, testing and patient pathways.
Compugen said it will release fourth quarter and full year 2025 results on March 2, 2026, and present at the Needham Virtual Healthcare Conference on April 13. The company also outlined its Phase 1 and Phase 3 immuno-oncology pipeline programs.
Phase 3 BREAKWATER found encorafenib plus cetuximab plus FOLFIRI improved PFS and response in first-line BRAF V600E-mutant metastatic colorectal cancer. OS data remain immature.
Research and Markets added two cell and gene therapy publications, including a tools and reagents market report forecasting growth from $12 billion in 2025 to $19.8 billion by 2030. The reports track approvals, financing, deals, and manufacturing developments.
