(Reuters)—The U.S. Food and Drug Administration said on Wednesday that it had approved Pfizer Inc’s drug, Xeljanz, to treat adults with moderate-to-severe active ulcerative colitis. The effectiveness of Xeljanz (tofacitinib) in treating ulcerative colitis was shown in three controlled clinical trials, including two trials that showed the drug caused disease remission in about 17-18 percent…
FDA Teams with Medical Companies in Puerto Rico to Tackle Shortages
(Reuters)—The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the U.S. as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria.1 Drugmakers are working to get…
Flexion’s Knee Pain Drug Gets FDA Approval
(Reuters)—Flexion Therapeutics Inc. said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration. The approval comes at a time when U.S. federal authorities are implementing a slew of measures to combat opioid abuse, with President Donald Trump in August declaring the opioid epidemic a national emergency. The…
Many Drug Companies Fail to Conduct Timely Safety Checks on Medicines after FDA Approval
(Reuters Health)—In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market. A September 20 online analysis in the New England Journal of Medicine concludes that, in many cases, that’s not being done….
FDA Approves Lesinurad + Allopurinol
Duzallo, a combination of lesinurad and allopurinol, was approved by the FDA in August to treat hyperuricemia associated with gout…
FDA Approves First Biosimilar for the Treatment of Cancer
Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment…
FDA Update: Biosiomilar to Adalimumab Receives FDA Approval
The FDA has approved adalimumab-adbm, a biosimilar, to treat multiple chronic inflammatory diseases…
Flimsy Evidence Behind Many FDA Approvals
(Reuters Health)—Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in JAMA, online Aug. 15. The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the…
Senate Reauthorizes FDA to Collect Fees from Drugmakers
(Reuters)—The U.S. Senate on Thursday passed a bill allowing the Food and Drug Administration to continue collecting fees from drug companies to review new product applications. The FDA Reauthorization Act renews an existing law that expires on Sept. 30 and which provides the majority of FDA funds used to review pharmaceuticals and determine whether they…
U.S. FDA Panel Votes Against Approval of Arthritis Drug Sirukumab
(Reuters)—The benefits of Johnson and Johnson’s experimental rheumatoid arthritis drug sirukumab do not outweigh the risks, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 12-1 that the drug should not be approved, citing safety concerns, including an imbalance in the number of deaths in patients taking sirukumab…