FDA grants priority review to application for Keytruda + concurrent chemoradiotherapy, as treatment for newly diagnosed high-risk locally advanced cervical cancer – Merck Inc

Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed […]

Statin therapy appears to lower the risk another stroke after a bleeding stroke

Patients who have suffered an intracerebral hemorrhage (bleeding stroke) who subsequently take statins appear to have a lower risk of having another stroke, especially an ischemic stroke, when compared to similar patients who did not take statins. Researchers reported these findings in Neurology on August 30, 2023. “Previous research has had mixed results on the risk of stroke in people […]

New ‘promising medicines’ fund may incentivise commercialisation of high price drugs with weak evidence on clinical benefits

A new fund to fast-track patient access to potentially valuable new medicines may incentivise the pharmaceutical industry to develop high priced drugs for rare diseases with weak evidence on clinical benefits. Health economics and policy academics from the London School of Hygiene & Tropical Medicine (LSHTM), writing in the Journal of the Royal Society of Medicine, warn that if the NHS England […]

Researchers to explore 3D printing medication tailored to pediatric patients

Researchers at Texas A&M University will spearhead a groundbreaking project to revolutionize medication administration for pediatric patients, thanks to an approximately $3 million grant from the National Institutes of Health (NIH). This pioneering initiative explores using additive manufacturing, or 3D printing, to create customized tablets tailored to the unique needs of young children. The project is an interdisciplinary collaboration of […]

New orally available drug for spinal cord injury found to be safe and tolerable in healthy participants

New research from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London has demonstrated the safety and tolerability of a new drug treatment designed as a therapeutic intervention for spinal cord injury (SCI). The research, published in British Journal of Clinical Pharmacology, found that the KCL-286 drug – which works by activating retinoic acid receptor beta (RARb) in the spine […]

Jardiance approved in the EU for the treatment of adults with chronic kidney disease – Boehringer + Eli Lilly

The European Commission (EC) approved Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company have announced. The approval has the potential to advance the standard of care for more than 47 million people in the EU living with CKD and help relieve burden on healthcare systems by reducing the risk […]

Vyalev a continuous subcutaneousinfusion for Parkinson’s disease is now launched in Japan – AbbVie

AbbVie has launched Vyalev (foslevodopa + foscarbidopa), a continuous subcutaneous infusion for Parkinson’s disease, in Japan on July 26. This is the first Parkinson’s drug in the country that can be continuously infused for 24 hours without requiring surgery. In Japan, Vyalev was approved in December 2022 for the improvement of wearing-off symptoms in Parkinson’s inadequately controlled with existing pharmacotherapies […]

Twice-yearly lenacapavir demonstrates sustained impact on health-related quality of life in people with HIV – Gilead Sciences

Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase II/III CAPELLA trial . These latest findings underscore the role of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its transformative potential impact on the future of coordinated HIV clinical […]

Biotronik receives FDA approval for next-generation family of pacemakers

Biotronik announced FDA approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P), its latest innovation in cardiac rhythm management. Amvia Edge, the market’s smallest single-chamber MR conditional pacemaker, introduces a unique set of patient-centric clinical solutions coupled with automated workflow efficiency. Amvia Edge pacemakers feature Biotronik’s proprietary MRI Guard 24/7 technology, which uses always-on, dedicated […]

Phase III TRuE-AD3 study of Opzelura meets primary endpoint in atopic dermatitis – Incyte

Incyte announced positive topline results from its randomized, vehicle-controlled, pivotal Phase III TRuE-AD3 study evaluating the safety and efficacy of Opzelura (ruxolitinib cream) in children (age at least 2 to <12 years) with atopic dermatitis (AD). The study met its primary endpoint and showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator’s Global Assessment Treatment Success […]