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#Migraine #CGRPinhibitor #EliLilly #FDA Eli Lilly & Co. got clearance from U.S. regulators for a new migraine drug that will be the third in a promising class of therapies for patients who suffer from the recurrent, painful headaches. The Food and Drug Administration approved galcanezumab, a so called CGRP-inhibitor that will be marketed under the name Emgality, on Thursday. Indianapolis-based Lilly said it will offer the drug at no cost for a year to millions of patients with commercial insurance, a move that reflects increased scrutiny of high prescription costs in the U.S. and fierce competition in a hot treatment area. Under that strategy, Lilly will be able to ensure patients are getting its medication even as insurers finalize coverage or reimbursement policies. “We’re providing this to make sure there’s no gap in the ability for patients to start should they need it,” said Wei-Li Shao, vice president of Lilly’s neuroscience business. Emgality is forecast to sell $...

#Dermira #Drug #Sweating #FDA #Qbrexza Dermira said on Friday its topical cloth for excessive armpit sweating was approved by the US Food and Drug Administration, providing patients with an easy-to-use option for an often embarrassing condition. Shares of the company were up more than 25 percent at $11.09 in trading before the bell. The treatment, Qbrexza, works by blocking receptors responsible for sweat gland activation and can be used once a day, the company said in a statement. About 10 million people are affected with the condition, known as primary axillary hyperhidrosis, which results in sweating beyond what is needed for regulating normal body temperature. The condition can affect a person’s psychological well-being and overall quality of life due to constant stressing over the appearance of underarm sweat marks and working to conceal them. “What we hear from patients is, ‘Wow, I’m glad it’s not just me. I’m embarrassed to talk to somebody about it, or I talked to a ph...

#Almond #FDA  #Lactate  #Milk  #Rice  #Soy The US Food and Drug Administration seems to have soured on nondairy milk-alternative products that use the term “milk” in their marketing and labeling—like popular soy and almond milk products. In a talk hosted by Politico, FDA Commissioner Scott Gottlieb announced Tuesday that the FDA will soon issue a new guidance on the use of the term. But he added that products aren’t abiding by FDA policies as they stand now. He referenced a so-called “standard of identity” policy that regulates how milk is defined and should be identified. “If you look at our standard of identity—there is a reference somewhere in the standard of identity to a lactating animal,” he said. “And, you know, an almond doesn’t lactate, I will confess.” He went on to explain that the issue is that the agency hasn’t been enforcing its own policy or putting the squeeze on product makers—and that it’s time to get abreast of the labeling language. B...