The FDA approved Merck's Keytruda in combination with Pfizer's Inlyta as therapy for treatment-naive patients with advanced renal cell carcinoma. Results from a February study showed that 90% of patients receiving the combination therapy were living after one year, compared with 78% of patients treated with a standalone therapy.
Two lots of fentanyl transdermal patches were recalled by Alvogen due to cartons of 50 mcg/h patches being mislabeled as 12 mcg/h. No adverse events have been reported.
Pfizer, Perrigo, Teva Pharmaceutical Industries, Apotex and the Association for Accessible Medicines are seeking further instruction from the FDA on its draft guidance related to the competitive generic therapy, or CGT, designation. The designation is meant to be an incentive for industry to develop generics for drugs with only one competitor, and the FDA has granted more than 100 CGT designations.
ADMA Biologics' intravenous immune globulin drug Asceniv has received FDA approval for treatment of primary humoral immunodeficiency disease. CEO Adam Grossman says the company hopes the drug will help alleviate current US IVIG shortages.
A draft guidance has been issued by the FDA to offer recommendations on nonclinical assessment of medtech products that contain nitinol. The proposed recommendations, which are open for comments until June 17, include providing the FDA with a flow chart of manufacturing processes and information on whether shape memory behavior is used.
AdvaMed has welcomed an International Trade Commission report on the economic impacts of the US-Mexico-Canada Agreement, lauding the identified medtech-specific benefits, including those that relate to reimbursement transparency and improved intellectual property rights. The report highlights the deal's "substantially positive" economic impact compared to the North American Free Trade Agreement, says Ralph Ives, AdvaMed's executive vice president of global strategy and analysis, noting the deal "will further regulatory harmonization across borders and foster expanded access to the latest medical technology innovations for the benefit of patients."
The coronary devices advisory panel of the FDA has scheduled a meeting on June 19 and 20 to discuss the risks associated with the use of paclitaxel-coated devices in patients with peripheral arterial disease, as well as appropriate regulatory actions.
A Consumer Reports review found 11 out of 130 bottled water brands contain detectable levels of arsenic. Consumer Reports has recommended the federal limit for bottled water be lowered to 3 ppb from 10 ppb.
Plans for an early-stage trial to assess Cellectis' UCARTCS1, the company's first allogeneic chimeric antigen receptor T-cell therapy to treat multiple myeloma patients, have been announced. The study will be conducted at the MD Anderson Cancer Center, the NewYork-Presbyterian-Weill Cornell Medical Center and Hackensack University Medical Center, with details regarding patient recruitment and an opening date for the sites to be disclosed.
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