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…
Docs & Patients Should Remember to Use Generics
(Reuters Health)—Prescribing generic medicines instead of brand name drugs whenever possible cuts costs, improves patient adherence and improves health outcomes, according to a new recommendation from the American College of Physicians. “Generic medications are cheaper and patients are more likely to get those prescriptions filled,” says Dr. Amir Qaseem of the American College of Physicians,…
Pfizer to Buy Allergan in $160 Billion Deal
NEW YORK (Reuters)—Pfizer Inc. on Monday said it would buy Botox maker Allergan Plc. in a deal worth $160 billion to slash its U.S. tax bill, rekindling a fierce political debate over the financial maneuver. The acquisition, which would shift Pfizer’s headquarters to Ireland, would be the biggest-ever tax inversion. The news prompted Democratic presidential…
Novartis to Pay $390 Million in U.S. Settlement over Pharmacy Kickbacks
WASHINGTON (Reuters)—Novartis Pharmaceuticals Corp. will pay $390 million to settle U.S. charges that it paid specialty pharmacies illegal kickbacks in exchange for inducing patients to refill certain medications, according to an accord announced Friday. The settlement between a U.S. unit of Swiss drugmaker Novartis AG, the federal government and more than 40 states concerns payments…
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