FDA Restricts Fluoroquinolone Use The U.S. Food and Drug Administration (FDA) has twice previously communicated safety information about systemic fluoroquinolones—in August 2013 and July 2008. The safety issues of this medication class described in its latest Drug Safety Communication were also discussed at a November 2015 FDA Advisory Committee meeting.1 The FDA is now advising…
(Reuters Health)—State programs that monitor narcotic prescriptions help prevent 10 opioid-overdose deaths a day in the U.S., yet improvements could save another two people a day, a new study finds. States with the most robust programs—ones that tracked a greater number of potentially addictive medications and updated their databases at least weekly—saw the biggest drops…
(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…
NEW YORK (Reuters)—A U.S. judge has slashed a $500 million verdict against Johnson and Johnson and its DePuy unit over allegedly defective metal-on-metal Pinnacle hip implants to approximately $151 million. On Tuesday, U.S. District Judge Ed Kinkeade in the Northern District of Texas says he was compelled to reduce the verdict under a Texas state…
In a recent study, 100% of patients with rheumatoid arthritis (RA) on infliximab experienced a cross-reaction when switched to its biosimilar (CT-P13, infliximab-dyyb). Plus in a recent study, a treat-to-target strategy proved effective for treating RA with biological disease-modifying anti-rheumatic drugs…
Debate continues about how biosimilars that are emerging to treat rheumatic diseases will be named and monitored, said panelists at a recent meeting in Washington, D.C.—Biosimilars in the United States: Next Steps. Angus Worthing, MD, FACR, FACP, a member of the ACR’s Government Affairs Committee, shared rheumatologists’ concerns as these new therapies come to market….
MADRID (Reuters)—The likely relocation of the European Medicines Agency (EMA) from London threatens to disrupt the approval of new drugs and is a medium and long-term worry for top Spanish drugmaker Almirall, its chief executive says on Monday. The EMA, Europe’s equivalent the U.S. Food and Drug Administration, approves medicines for all European Union countries…
A recent study found that certolizumab pegol plus methotrexate is effective in achieving sustained remission and low disease activity in patients with early active RA…
The FDA is currently accepting comments on a draft guideline for osteoporosis treatments, which calls for more research into the long-term effects of drugs on bone quality. Also, the FDA has rejected an application for approval of Apadaz in its current form…
PARIS (Reuters)—Paris prosecutors said on Tuesday they have begun an involuntary manslaughter investigation into a failed drug trial that left one dead and five hospitalized in January. The prosecutors’ office said the investigation had been opened to determine whether there was a criminal element in any mistakes made or whether it was simply the result…