The FDA on Tuesday opened a 90-day comment period on the harmful effects of menthol and other tobacco flavorings as it considers prohibiting the sale and distribution of flavored tobacco products as part of its efforts to curb smoking by children. Robin Koval, president and CEO of Truth Initiative, an advocacy group targeting youth smoking, expressed support for the FDA initiative, but the Campaign for Tobacco-Free Kids questioned the need for more input and called for immediate action on regulating flavored tobacco products.
The FDA approved Seattle Genetics' supplemental new drug application for Adcetris, or brentuximab vedotin, in combination with chemotherapy, as a treatment for adult patients with previously untreated stage III or IV classical Hodgkin lymphoma. The decision, which precedes the drug's May 1 action date, was based on a Phase III study result in which the drug plus chemotherapy achieved the primary endpoint of improving two-year modified progression-free survival rate compared with chemotherapy alone.
The FDA granted orphan drug designation to Trillium Therapeutics' early-stage TTI-621, which is being developed as a treatment for patients with cutaneous T-cell lymphoma.
The National Institute for Health and Care Excellence recommended against the use of Dompe's cenegermin to treat neurotrophic keratitis. The cost regulator did not find enough evidence showing the clinical effectiveness of cenegermin and ruled that the drug's benefit did not meet cost-effectiveness standards.
Anna's Pies' bakery in Lake Charles, La., received a warning from the FDA because of serious violations, which caused the company's products to be adulterated "within the meaning" of the Federal Food, Drug and Cosmetic Act, the agency said. According to the letter, the facility failed to take required steps to ensure that food-handling techniques, pest protection, facility cleaning and sanitization are in accordance with food safety rules.
The FDA granted Exactech 510(k) clearance for its Novation XLE Vitamin E acetabular polyethylene liners for hip replacement surgery. The liners, which are intended to be used with the Novation Crown Cup Acetabular System, has a material for low wear that alleviates the effects of oxidation before and after implantation through its vitamin E content.
European regulators granted Iridex CE mark approval for its G-Probe Illuminate, a device designed to provide laser fiber and transillumination for targeted transscleral cyclophotocoagulation. The probe, powered by the CYCLO G6 glaucoma laser system, comes with built-in transillumination that allows for optimization of device placement and therapeutic outcomes.
The first two patients in a study of Colibri Heart Valve's second-generation expandable 24mm and 27mm transcatheter aortic valve system were enrolled and have indicated single-digit mmHg mean aortic valve pressure gradients without observed paravalvular leakage or aortic insufficiency following implantation of the valves. The study aims to assess early feasibility of the system, as well as deployment characteristics, and will include up to 10 patients, with enrollment expected to be completed about mid-April.
Regardless of patient characteristics, an Italian study found that hepatitis C treatment with Mavyret, or glecaprevir/pibrentasvir, for eight weeks resulted in an overall sustained virologic response rate of 98% in patients with genotypes 1 through 6, with those treated for 12 weeks achieving 99% SVR, according to the Journal of Hepatology. The researchers analyzed data from 2,041 patients with varying HCV genotypes who had no cirrhosis, with 965 treated for eight weeks and 1,076 taking the regimen for 12 weeks.
Biopharmaceutical firm Unum Therapeutics is slated to launch its initial public offering with the sale of 5.77 million shares of common stock valued between $12 and $14. Unum is developing a proprietary technology called Antibody-Coupled T cell Receptor that is being evaluated in an early-stage clinical trial for treatment-resistant non-Hodgkin lymphoma.
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