News from Wednesday, February 5, 2025
Articles
UK: Novartis Secures MHRA Authorisation for Ribociclib
(2/5, John Pinching, PharmaTimes) reports “Novartis UK announced the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised ribociclib for adjuvant treatment in combination with an aromatase inhibitor (AI) for patients with HR+/HER2- early breast cancer at high risk of recurrence. Previously, this treatment was only licensed for advanced breast cancer.” Full
Gene Editing Therapy Casgevy Now Funded In 8 Countries But French Access Withdrawn
(2/5, Eliza Slawther, Pink Sheet) reports “...England’s health technology assessment (HTA) agency, NICE, has formally agreed to reimburse Vertex/CRISPR Therapeutics AG’s CRISPR/Cas9-based gene editing therapy Casgevy (exagamglogene autotemcel), also known as exa-cel, to treat patients with sickle cell disease (SCD).” Subscription Required
Swedish Drug Agency's New Pricing Model Surprises, Concerns Patient and Pharma Groups
(2/5, Monica Kleja, Euractiv) reports “The Swedish pharmaceutical pricing agency could decline to reimburse medication for a common disease. The new refusal option is primed if the drug's total sales value is deemed excessively high. The agency says savings will allow for higher prices of orphan drugs for serious rare conditions.” Full
Press Releases
$10.8 Million Award Funds USC-Led Clinical Trial to Improve Hip Fracture Outcomes
(2/4, Keck School of Medicine of USC) “ The University of Southern California has been approved for $10.8 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) to compare approaches to treating older adults with a fracture of the hip. Led by principal investigator Joseph Patterson, MD, an orthopaedic surgeon specializing in fracture care at Keck Medicine of USC, the ‘FASTER-Hip’ trial aims to determine whether patients with a certain type of hip fracture fare better with a hip replacement or a simpler surgery known as internal fixation.” Full
Research Team Could Redefine Biomedical Research
(2/4, Georgia State University Press Release) “Professor Leslie Wolf, a Distinguished University Professor and Ben F. Johnson Jr. Chair in Law at Georgia State University College of Law, is a part of a research team that has been provided $1.9 million to conduct research designed to increase participation in biomedical studies by involving participants in the research design process. The award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.” Full
Journals
Two-Fraction Versus Five-Fraction Stereotactic Body Radiotherapy for Intermediate-Risk Prostate Cancer: The TOFFEE Meta-Analysis of Individual Patient Data from Four Prospective Trials
Cristian Udovicich, et al.
February 3, 2025, European Urology Oncology
Clinical Briefing: Cancer Outcomes Predicted Using AI-Extracted Data from Clinical Notes
February 5, 2025, Nature