Matthew Perrone

The Food and Drug Administration approved 41 first-of-a-kind drugs in 2014, including a record number of medicines for rare diseases, pushing the agency’s annual tally of drug approvals to its highest level in 18 years. FDA drug approvals are considered a barometer of industry innovation and the federal government’s efficiency in reviewing new therapies. Last year’s total was the most since the all-time high of 53 drugs approved in 1996. Triangle connection: Check out the links posted with this story about drugs winning FDA approval which have a Triangle connection. The 2014 approval list includes 15 drugs for so-called...

Pfizer Inc. is teaming up with DNA testing company 23andMe to study the possible genetic underpinnings of inflammatory bowel disease, a hard-to-treat ailment that affects an estimated 1.4 million Americans. Under the agreement, Silicon Valley-based 23andMe will map the DNA of 10,000 patients who have forms of the disease, which include Crohn’s disease and ulcerative colitis. Patients will submit saliva samples using 23andMe’s at-home collection kit and then fill out online questionnaires about their disease and symptoms. The companies hope to identify genetic similarities among patients with the disease, which could eventually guide development of new targeted drugs. “Our...

The multi-decade search for a pill that boosts sexual desire in women has hit another roadblock, raising questions about the future of efforts to develop a female equivalent to Viagra. Sprout Pharmaceuticals said Wednesday it has reached an impasse with the Food and Drug Administration over its drug, flibanserin. The daily pill is designed to increase libido in women by acting on brain chemicals linked to mood and appetite. The FDA questions whether the drug’s benefits outweigh its risks, considering its “modest” effectiveness and side effects including fatigue, dizziness and nausea. Sprout said it is appealing an October letter...

Bottles of Tylenol sold in the U.S. will soon bear red warnings alerting users to the potentially fatal risks of taking too much of the popular pain reliever. The unusual step, disclosed by the company that makes Tylenol, comes amid a growing number of lawsuits and pressure from the federal government that could have widespread ramifications for a medicine taken by millions of people every day. Johnson & Johnson says the warning will appear on the cap of new bottles of Extra Strength Tylenol sold in the U.S. starting in October and on most other Tylenol bottles in coming...