Novo Nordisk's once-weekly Ozempic, or semaglutide injection, was approved by the FDA for use in adult patients with type 2 diabetes as an adjunct to exercise and diet for the improvement of glycemic control.
The FDA granted Sonoma Pharmaceuticals approval to include an antimicrobial claim for its Alevicyn SG Antipruritic Spray Gel, a treatment for atopic dermatitis or eczema. Data showing effectiveness of the gel against clinically relevant organisms was included in the approval.
Sanofi terminated development of its Clostridium difficile vaccine based on an Independent Data Monitoring Committee's assessment that the vaccine had a low probability of success after looking at interim data from a late-stage study.
The National Institute for Health and Care Excellence recommended against National Health Service and Cancer Drugs Fund use of Novartis' Rydapt, or midostaurin, as a treatment for patients with FLT3-mutated acute myeloid leukemia. The regulator did not consider the drug cost-effective and was uncertain of Rydapt's effectiveness in people older than age 60 because a clinical trial did not include that age group.
Roche Holding's Roactemra, or tocilizumab, was turned down by the National Institute for Health and Care Excellence for funding by the National Health Service as a therapy for patients with giant cell arteritis. The institute did not find enough evidence showing how long patients would need to take Roactemra and what its long-term benefits would be and ruled that the drug's benefit did not meet cost-effectiveness standards.
Health Research Laboratories has settled with the state of Maine and the Federal Trade Commission on charges that it misbranded its brain supplement NeuroPlus and dietary supplement BioTherepex. The FTC said the supplements were marketed as treatments that could reverse memory loss, prevent dementia, treat arthritis and lead to weight loss, and the company used direct-mail brochures featuring quotes from nonexistent consumers, doctors and, in one case, a false clinical study to back up the claims.
The global halt of implants of the Nanostim leadless pacemaker, manufactured by Abbott unit St. Jude Medical, remains in place after Abbott received reports about the detachment of the device's docking button, but there have been no serious injuries. The company recommended continued following of patients and said retrieval may be done only if the docking button is intact as shown by X-rays and if the procedure can be executed per usage instructions.
Brainlab's Contrast Clearance Analysis software, which is intended for providing more insight into post-treatment tumor characteristics, was granted 510(k) clearance by the FDA. The software allows for MR image analysis to differentiate efficient contrast clearance regions from regions with contrast accumulation in most patients with cranial tumors.
Second Sight Medical's Argus II retinal prosthesis system was introduced in Iran through the company's exclusive distribution partner, Arshia Gostar Darman. Two patients in the country have undergone implantation of the system, which uses electrical stimulation to induce visual perception in patients with retinitis pigmentosa.
May 3-4 | Washington, D.C. The premier conference for the food and drug law community, the FDLI Annual Conference addresses every product category regulated by the FDA. The two-day event will bring together industry experts to cover the latest legal, regulatory and policy issues. Learn more.
In this article, Chia-Feng Lu (Baker McKenzie) examines the Japanese government's efforts to revitalize its life sciences industry by attracting more clinical development activities and facilitating the discovery and development of novel therapies. Read online.