LONDON (Reuters)—The number of new drugs approved in the U.S. this year has already topped last year’s 18-year high, yet large pharmaceutical companies are still struggling to get a decent return on their research dollars. In fact, returns on research and development (R&D) spending by the world’s top drug makers have fallen to just 4.2%,…
Valeant Hires Attorney, Crisis Management Firm as U.S. Scrutiny Mounts
WASHINGTON/NEW YORK (Reuters)—Pharmaceuticals firm Valeant, under mounting pressure from Congress and prosecutors over its drug pricing, has hired an attorney in Washington, D.C., and crisis public relations experts with political connections, according to sources familiar with the matter. The move, confirmed by sources and through documents viewed by Reuters, signals a shift for Valeant Pharmaceuticals,…
Dr. Michael Weinblatt Discusses Current & Future RA Therapies
According to former ACR President Michael Weinblatt, MD, the future of drug therapies for patients with RA rests in the careful and intelligent prescription of current medications and treatment combinations, as well as better patient access through lower costs…
Smarter Regulation Can Help Cut Drug Prices, Says EU Agency Head
LONDON (Reuters)—Europe’s top drug regulator weighed into the medicine pricing debate on Wednesday, arguing a smarter and faster pharmaceutical approval system was needed to help rein in the spiraling cost of new treatments. In exchange for speeding up the approval process, society would expect manufacturers to charge less for innovative medicines, European Medicines Agency (EMA)…
FDA Approves Drug to Counter Opioid ODs
The FDA recently approved a form of naloxone hydrochloride in a nasal spray that will help counter opioid overdoses. The FDA also approved an ibuprofen injection as an adjunct to opioids for use in children 6 months and older…
Researchers Find Rheumatologists Are Prescribing Methotrexate Less Often to Treat RA
An analysis by former ACR President James O’Dell, MD, and colleagues shows that rheumatologists may be moving too quickly from methotrexate therapy to biologics when treating patients with RA…
Etanercept Biosimilars Promising in Clinical Studies
In multiple clinical studies, investigational biosimilars for etanercept were shown to be safe and effective for treating rheumatoid arthritis and moderate to severe plaque psoriasis…
One-Year Data Shows Apremilast Effective in Severe Scalp, Nail Psoriasis
NEW YORK (Reuters Health)—Apremilast is effective in patients with difficult to treat psoriasis of the scalp and nails, according to long-term results of two phase 3 trials. Investigators had previously reported 16-week data from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2 trials. The new report includes…
Amgen Files for U.S. Approval of Biosimilar
(Reuters)—Amgen Inc. on Wednesday said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie’s Humira (adalimumab), the world’s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira in late stage clinical trials…
Oxycodone Capsules Put on Hold; Clinical Trials for Lupus Nephritis & SLE Therapies
Due to a lawsuit, the FDA has issued only tentative approval for an extended-release oxycodone capsule. Obinutuzumab is in clinical trials for lupus nephritis, and subcutaneous belimumab is being tested for SLE…
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