FDA Green-Lights Libido-Enhancing Drug For Postmenopausal Women
The drug, Addyi, was first approved a decade ago for premenopausal women but comes with some unpleasant side effects. Also: a warning to retailers about tainted formula, a lawsuit over paraquat and Parkinson's, and more.
AP:
FDA Expands Approval Of Libido Drug Addyi For Postmenopausal Women
U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido, saying the once-a-day pill can now be taken by postmenopausal women up to 65 years old. The announcement Monday from the Food and Drug Administration broadens the drug’s use to older women who have gone through menopause. The pill, Addyi, was first approved 10 years ago for premenopausal women who report emotional stress due to low sex drive. (Perrone, 12/15)
Politico:
New Anti-Abortion Campaign Takes Aim At EPA Water Testing Rules
An influential anti-abortion group is rallying its supporters around the country to flood EPA with requests to add mifepristone — a drug used in more than two-thirds of all abortions — to a list of drinking water contaminants tracked by public utilities. The strategy by Students for Life of America to target EPA’s rule-making process, which grew out of a recent meeting with EPA staff, is the latest move in a yearslong crusade by abortion opponents to use environmental laws to restrict abortion. (Ollstein and Wittenberg, 12/15)
CNN:
FDA Sends Warning Letters To Major Retailers For Selling Recalled Formula Linked To Infant Botulism Outbreak
The US Food and Drug Administration sent warning letters to Target, Walmart, Kroger and Albertsons after some of the stores failed to remove recalled baby formula linked to a large infant botulism outbreak. The FDA said it communicated with the retailers about the recall repeatedly, even sending several emails requesting plans of action to comply with the recall, but none of the companies responded to the request. (Christensen, 12/15)
Bloomberg:
Sanofi To Pay Dren Bio Up To $1.8 Billion For Autoimmune Drug Development
Sanofi agreed to pay US biotech Dren Bio as much as $1.8 billion, including $100 million upfront, as the French company expands a push to develop medicines for immune-system diseases. The two companies will use closely held Dren Bio’s platform to discover new drug candidates which Sanofi will then develop and commercialize, according to a statement Monday. The terms are largely made up of conditional payments to Dren Bio dependent on the experimental medicines reaching certain milestones. (Furlong, 12/15)
MLive:
Paraquat, A Pesticide Sprayed On U.S. Farms, Blamed For Parkinson’s In Lawsuit
Paul Friday remembers when his hand started flopping in the cold weather – the first sign nerve cells in his brain were dying. He was eventually diagnosed with Parkinson’s, a brain disease that gets worse over time. His limbs got stiffer. He struggled to walk. He couldn’t keep living on his family farm. Shortly afterward, Friday came to believe that decades of spraying a pesticide called paraquat at his peach orchard in southwestern Michigan may be the culprit. (White, 12/15)
