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…
Drug Makers Inconsistent in Sharing Clinical Trial Data
(Reuters Health)—Drug companies are inconsistent about disclosing data related to clinical trials of new medicines, a new report says. Researchers examined publicly available data on clinical trials for 15 new medicines from 10 companies that were cleared for sale by the U.S. Food and Drug Administration in 2012. Two of the companies disclosed all trials…
U.S. Doctor Group Calls for Ban on Drug Advertising to Consumers
(Reuters)—The American Medical Association on Tuesday called for a ban on advertising prescription drugs and medical devices directly to consumers, saying the ads drive patients to demand expensive treatments over less costly ones that are also effective. The influential doctors’ group said the new policy reflects physicians’ concerns that marketing spending on a proliferation of…
FDA Approves 2 Pain Drugs & New Gout Treatment on Road to Approval
The FDA has approved two drugs designed to manage pain: buprenorphine for chronic pain and meloxicam capsules for OA pain. Lesurinad is also closer to FDA approval for treating gout…
Obama Nominee to Lead FDA Defends Drug Industry Ties
(Reuters)—President Barack Obama’s nominee to head the U.S. Food and Drug Administration defended his ties to the pharmaceutical industry on Tuesday during a Senate committee hearing that included questions on soaring drug prices. Presidential candidate Bernie Sanders was among the Democrats who grilled Dr. Robert Califf (64), who joined the FDA in January as a…
WHO Warns of Widespread Misunderstanding of Superbug Threat
LONDON (Reuters)—People across the world are confused about the major threat to public health posed by drug-resistant superbugs and do not know how to stop that risk growing, the World Health Organization (WHO) said on Monday. Ramping up its fight against antibiotic resistance with a survey of public awareness, the United Nations health agency said…
Rheumatology Drug Updates on Brentuximab Vedotin, Tofacitinib Citrate
Brentuximab Vedotin Enters Phase 2 Trials Brentuximab vedotin (Adcetris), an antibody-drug conjugate (ADC) directed at CD30, is currently entering Phase 2 clinical trials for treating systemic lupus erythematosus (SLE).1 The ADC encompasses an anti-CD30 monoclonal antibody, which is attached by a protease-cleavable linker to a microtubule-disrupting agent, known as monomethyl auristatin E (MMAE). The ADC…
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