For the first time since August, the volume of clinical data has dipped, with 388 items of phase I, II and III data in November, a 4% decrease compared with the prior month. Again, 17% of the entries during the month are focused on vaccines and therapeutics to fight the SARS-CoV-2 virus. The same percentage held true in October. The pandemic accounted for 16% of the clinical data in September, 15% in August and 16% in July.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS announces testing agreements; TGA slaps two companies for violations.
Neuroem Therapeutics Inc. has received breakthrough device designation from the U.S. FDA for Memorem, a bioengineered, wearable head device for the treatment of Alzheimer’s disease. The breakthrough nod, which entitles companies to an expedited regulatory process, follows results from a pilot study showing Memorem can reverse memory loss in patients with the debilitating brain disorder.
The U.S. FDA has given the green light to a new type of treatment to help smokers quit, clearing the way for the first time the use of deep transcranial magnetic stimulation (Deep TMS) for short-term smoking cessation in adults.
The number of FDA approvals tracked by BioWorld have continued their steady incline, with a total of 129 logged through July, placing 2020 at a five-year high.
In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the FDA said, “All of these scores indicate an acceptable level of compliance to CGMPs [current good manufacturing practices] on average.”
Medrhythms Inc., a digital therapeutics startup based in Portland, Maine, won an FDA breakthrough device designation for its Rhythmic Auditory Stimulation (RAS) treatment platform for people with chronic walking impairments due to stroke.
While a significant number of clinical trial delays occurred during the month of April, it was business as usual from a regulatory standpoint for companies with late-stage therapies ready for the market and for those targeting underserved patient populations.
HONG KONG - India has made amendments to the export policy of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs.
