The FDA has granted Senseonics approval for its Eversense continuous glucose monitoring system for use in patients with diabetes. The device, which comes with an implantable glucose sensor, provides up to three months of long-term continuous monitoring.
Voyager Therapeutics' drug candidate VY-AADC, being developed to treat patients with Parkinson's disease whose motor fluctuations cannot be controlled, received regenerative medicine advanced therapy status from the FDA.
Bristol-Myers Squibb's supplemental biologics license application for Opdivo, or nivolumab, in combination with low-dose Yervoy, or ipilimumab, was accepted by the FDA for review. The application covers the use of the combination as a treatment for patients with first-line non-small cell lung cancer with at least 10 mutations per megabase.
Novo Nordisk's oral semaglutide met the primary endpoint of reducing blood glucose levels, similar to its own injectable treatment Victoza, or liraglutide, but surpassed Victoza in reducing body weight, according to the results of Phase III trials. Oral semaglutide also surpassed Merck's Januvia, or sitagliptin, in reducing long-term blood glucose levels and patient body weight.
Australia's Therapeutic Goods Administration approved iX Biopharma's Wafesil, or sublingual sildenafil wafer, for use to treat male patients with erectile dysfunction. An Australian committee will discuss this month whether to reclassify the drug from prescription to nonprescription status.
The FDA approved Mumbai, India-based Cipla's abbreviated new drug application for testosterone cypionate injection 100 mg/mL and 200 mg/mL as a replacement therapy in male patients with symptoms of deficiency or absence of endogenous testosterone. The drug is an AO-rated generic therapeutic equivalent version of Pharmacia and Upjohn's Depo-Testosterone.
Agri Star Meat and Poultry issued a recall of more than 3,500 pounds of beef pastrami after testing prompted by a consumer complaint revealed that the meat did not contain an adequate amount of curing solution. The recalled products were sold under the Aaron's Best and Shor Habor brands with establishment number EST. 4653A and were distributed in California, Florida, Illinois, Washington state and New York.
A CE mark study has been initiated by Irvine, Calif.-based JenaValve Technology to assess use of its next-generation JenaValve Pericardial Transcatheter Aortic Valve Replacement System for treating severe aortic regurgitation in patients who face an elevated risk for conventional surgical valve replacement. The company, which expects to complete enrollment by year-end, hopes to secure CE mark approval from European regulators for the system by the second half of next year.
"Corazon," a short film based on a true-life relationship between a doctor and patient, won the Health and Wellness Grand Prix at this year's Cannes Lions International Festival of Creativity. The film was produced by John X Hannes USA and is part of a larger push to bring attention to the need for organ donors.
AbbVie partnered with Aardman Animations to create an online game with an embedded quiz designed to find out why people avoid visiting the doctor, even when they have worrisome symptoms. The companies are analyzing data from 4,500 players in an effort to help providers such as England's National Health Service figure out how to get people to visit doctors for preventive treatment.
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