The U.S. Food and Drug Administration (FDA) has toughened the existing warnings for nonsteroidal anti-inflammatory drugs (NSAIDs) due to their stroke and myocardial infarction (MI) risk increase.1 Due to a continual review of these products, FDA is requiring label updates for all prescription NSAIDs. Over-the-counter (OTC) NSAIDs already list the increased risk of MI and…
In a global Phase 3 trial, subcutaneous secukinumab proved safe and effective in patients with psoriatic arthritis. Also, a version of aspartyl-alanyl diketopiperazine, a biologic for knee OA, has entered Phase 3 trials…
LONDON (Reuters)—U.S. prices for the world’s 20 top-selling medicines are, on average, three times higher than in Britain, according to an analysis carried out for Reuters. The finding underscores a transatlantic gulf between the price of treatments for a range of diseases and follows demands for lower drug costs in America from industry critics such…
NEW YORK (Reuters Health)—Tabalumab, a monoclonal antibody to B-cell activating factor, was modestly better than placebo in relieving symptoms of systemic lupus erythematosus (SLE), according to results from the ILLUMINATE-2 trial. “Lupus is a complicated disease that does not behave the same way in all patients who share the clinical symptoms,” Dr. Joan T. Merrill…
NEW YORK (Reuters)—U.S. biotech shares extended their recent downward spiral on Tuesday as concerns about drug pricing continued to plague the sector while disappointing news from Illumina and other companies added to selling pressure. The Nasdaq Biotechnology index, down 4%, has now fallen about 17% since just before Hillary Clinton, front-runner to be the Democratic nominee…
A recent study showed ustekinumab can be used to treat teens with moderate to severe psoriasis. Also, Phase 2 trials for an analgesic combination drug show it holds promise for reducing post-operative pain…
ZURICH (Reuters)—The U.S. Food and Drug Administration has accepted Novartis unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s blockbuster anti-TNF drug Enbrel, the Swiss drugmaker said on Friday. Enbrel, or etanercept as the drug is known generically, is a big prize since it was the world’s fifth-biggest selling medicine in 2014…
NEW YORK (Reuters)—Teva Pharmaceutical Industries Ltd’s research chief said on Tuesday the drug industry must act responsibly when it comes to pricing medications, given the mounting anger over the high cost of therapies in the U.S. Democratic presidential candidate Hillary Clinton brought new attention to the issue last week, proposing to cap patients’ treatment costs,…
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.
Severe and disabling joint pain has been connected to the use of dipeptidyl peptidase-4 inhibitors and combination therapies for diabetes, prompting a new FDA warning…