PARIS (Reuters)—An initial report into a drug trial in northwestern France that left one person dead and five others hospitalized last month did not identify the exact cause, French Health Minister Marisol Touraine said on Thursday. Touraine told a news conference that the condition of the five people who were hospitalized was improving and that…
Articles by Natasha Yetman
Bowing to Pressure, FDA to Reform Painkiller Approval Process
WASHINGTON (Reuters)—Bowing to pressure from lawmakers, Dr. Robert Califf, President Barack Obama’s nominee to lead the U.S. Food and Drug Administration (FDA), said on Thursday the agency would reform its process for approving opioid painkillers. Last month, Sen. Edward Markey (D-Ma.) placed a hold on Califf’s nomination, preventing it from being voted on by the…
U.S. Appeals Court: Hospitals Can Be ‘Urban’ & ‘Rural’ at Same Time
NEW YORK (Reuters)—The federal appeals court in New York struck down a U.S. regulation that made it harder for hospitals to provide better medical care at lower cost by claiming they were “rural” for some purposes and “urban” for others. Thursday’s decision by the Second U.S. Circuit Court of Appeals is a victory for hospitals…
FDA Advisory Panel Strongly Backs Biosimilar Form of Remicade
(Reuters)—A medical advisory panel to the U.S. Food and Drug Administration on Tuesday recommended approval of a cheaper biosimilar form of Johnson & Johnson’s arthritis drug Remicade (infliximab) that could eventually batter sales of the branded product. The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc. and Pfizer Inc.,…
California Doctor Gets 30 Years to Life in Landmark Overdose Case
LOS ANGELES (Reuters)—A Southern California doctor was sentenced to 30 years to life in prison on Friday for over-prescribing drugs that caused the fatal overdose of three patients in a murder case capped by the first conviction of its kind in the U.S. The case against Dr. Hsiu Ying “Lisa” Tseng, 46, comes amid what…
CVS to Make Overdose Drug Naloxone Prescription-Free in Ohio
(Reuters)—CVS Health Corp said it would make naloxone, available without a prescription at all its pharmacies across Ohio, a state with one of the highest rates of overdose-related deaths. Naloxone is already available without a prescription in CVS Health stores in more than a dozen states. Drug overdoses increased 6.5% in 2014 from a year…
U.S. Appeals Court Ruling May Clear Barrier to Generic OxyContin
(Reuters)—A federal appeals court ruled Monday that four patents related to Purdue Pharma’s painkiller OxyContin are invalid, potentially bringing Teva Pharmaceutical Industries Ltd and others a step closer to introducing generic versions of the drug. Privately owned, Connecticut-based Purdue had sued Teva, Amneal Pharmaceuticals and Epic Pharma after they sought approval from the U.S. Food…
Newly Released Documents Show Profit-Seeking Behind Price Hikes at Turing, Valeant
WASHINGTON/NEW YORK (Reuters)—A decision by Turing Pharmaceuticals to raise the price of a lifesaving drug by 5,000% drove up some patient co-pays to as high as $16,000, according to excerpts of documents that congressional committee members released on Tuesday. The excerpts, which are highlighted in memos released by Democrats on the powerful U.S. House of…
Apremilast Effective for Psoriatic Arthritis
NEW YORK (Reuters Health)—Apremilast improves clinical outcomes in patients with psoriatic arthritis and active psoriasis, according to results from the PALACE 3 randomized controlled trial. Apremilast, a phosphodiesterase 4 (PDE4) inhibitor, showed efficacy against psoriatic arthritis in the PALACE 1 trial. Dr. Christopher J. Edwards from University Hospital Southampton in the U.K. and colleagues evaluated…
Newer Biologics for RA on Par with TNF-Inhibitors for CV Risk
NEW YORK (Reuters Health)—The newer disease-modifying drugs for rheumatoid arthritis appear to offer the same or even better cardiovascular (CV) protection than older tumor necrosis factor (TNF) inhibitors, hints a large study. “We really haven’t had a good understanding on where the non-TNF biologics and CV risk stand,” Dr. Jeffrey R. Curtis of the University…
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