Apparently, This New FDA-Registered Face Mask Doesn’t Hide Your Face And Gives You Extraordinary ProtectionAs face masks became such a vital part of our everyday lives, people soon started to notice all the limitations surrounding them. Some complain that most masks make it hard to breathe, some say that they're too hot, and some are annoyed that they make their glasses fog up. The list goes on.1
U.S. already at 100,000 new coronavirus cases a day, it just isn't testing them all, former FDA Commissioner Gottlieb says"States like Texas and Florida, they're falling behind on testing right now because the testing isn't evenly distributed across the country," former FDA Commissioner Dr. Scott Gottlieb said.
Ultragenyx gets second FdA approval in JuneShares of Ultragenyx Pharmaceutical Inc. gained 1% in premarket trading on Tuesday, the day after the Food and Drug Administration approved Dojolvi in the treatment of a rare set of genetic metabolic disorders. People with long-chain fatty acid oxidation disorders can't convert fatty acids into energy. "While we have been able to identify these disorders at birth for many years, treatment options have been limited," Dr. Jerry Vockley, chief of medical genetics at Children's Hospital of Pittsburgh of UPMC, said in a news release. "Dojolvi brings hope as a new tool now available to clinicians taking care of these patients." The net price for the drug is $138,000 for adults, according to Bernstein analyst Vincent Chen, who also said "pricing reasonably in line with but slightly to the higher end of expectations." The company's estimates for the patient population in the U.S. range between 2,000 and 3,500 people. Ultragenyx also received another FDA approval in June, for Crysvita as a treatment for some patients with tumor-induced osteomalacia. The company's stock is up 83.1% year-to-date, while the S&P 500 is down 4.0%.
Merck gets FDA OK for bladder-cancer treatmentMerck KGaA said late Tuesday that the U.S. Food and Drug Administration has fully approved the supplemental Biologics License Application for Bavencio, a treatment for patients with bladder cancer. The German pharmaceutical and chemicals company said the approval comes after an accelerated approval program in 2017 for the treatment of those with bladder cancer that has progressed during or following platinum-containing chemotherapy.
FDA issues rules for coronavirus vaccine developersThe Food and Drug Administration (FDA) issued new rules on Tuesday for the companies developing COVID-19 vaccines. "While the FDA is committed to help expedite this work, we will not cut corners in our decision making, and we're making clear in our guidance what are the data that we need, that should be submitted, to meet our regulatory standards of approval," FDA commissioner Dr. Stephen Hahn said Tuesday during a Senate committee hearing. The guidance states that the primary efficacy endpoint in a placebo-controlled efficacy clinical trial should be at least 50%, meaning the vaccine needs "to reduce the risk of disease caused by COVID-19 by 50%" when compared to the placebo, according to Brad Loncar, a longtime biotech investor and CEO of Loncar Investments. There are a number of drugmakers developing COVID-19 vaccine candidates including AstraZeneca and the University of Oxford, Inovio Pharmaceuticals Inc. , and Moderna Inc. , two of which (Inovio and Moderna) have disclosed preliminary data from their Phase 1 trials. A return to economic normalcy has largely been tied to the arrival of vaccines that can prevent infections from the coronavirus. "There is no guarantee...that we will have a safe and effective vaccine, but we are cautiously optimistic," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, testified during the same hearing.