MADRID (Reuters)—The likely relocation of the European Medicines Agency (EMA) from London threatens to disrupt the approval of new drugs and is a medium and long-term worry for top Spanish drugmaker Almirall, its chief executive says on Monday. The EMA, Europe’s equivalent the U.S. Food and Drug Administration, approves medicines for all European Union countries…
Certolizumab Pegol Combination Therapy Better than Methotrexate Monotherapy in DMARD-Naive Patients with RA
A recent study found that certolizumab pegol plus methotrexate is effective in achieving sustained remission and low disease activity in patients with early active RA…
Comment Period Open for FDA Draft Guidance on Osteoporosis Treatments; Plus FDA Rejects Abuse-Deterrent Apadaz
The FDA is currently accepting comments on a draft guideline for osteoporosis treatments, which calls for more research into the long-term effects of drugs on bone quality. Also, the FDA has rejected an application for approval of Apadaz in its current form…
French Prosecutors Open Probe into Fatal Drug Trial
PARIS (Reuters)—Paris prosecutors said on Tuesday they have begun an involuntary manslaughter investigation into a failed drug trial that left one dead and five hospitalized in January. The prosecutors’ office said the investigation had been opened to determine whether there was a criminal element in any mistakes made or whether it was simply the result…
Arthritis Patients Lack Knowledge about Safe Use of Biologics
NEW YORK (Reuters Health)—Many patients with arthritis lack the knowledge to use their biologic treatments safely, researchers from France report. “Some patients are at risk of poorly managing their biologic therapy, especially patients living alone, in a large city, patients with low education level, or (patients who are) unemployed,” Dr. Anne-Christine Rat from CHU de…
Adalimumab & Infliximab Remain in Newborns after Delivery
A recent study showed that, when administered during pregnancy, infliximab takes longer to clear an infant’s system than adalimumab…
Certolizumab Combo Helps Curb RA Damage
NEW YORK (Reuters Health)—Certolizumab pegol (Cimzia, UCB Pharma) in combination with methotrexate does better than methotrexate alone in certain patients with early rheumatoid arthritis (RA), according to one-year results from a new trial. As Dr. Paul Emery of the University of Leeds, UK, explains in an email to Reuters Health, “This study used a unique…
Rheumatology Drug Updates: Etanercept for Pediatric Plaque Psoriasis
Etanercept Submitted for Chronic, Severe Plaque Psoriasis in Children The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for etanercept (Enbrel) for treating pediatric patients with chronic, severe plaque psoriasis.1 The application was submitted in early January 2016 and is based on results of a one-year Phase 3 study with…
Monitoring Doctors Cuts Opioid Prescriptions
(Reuters Health)—Doctors in states that track painkiller prescriptions were nearly one-third less likely to offer patients dangerously addicting opioids, a new study found. The launch of drug-monitoring programs in 24 states led to an immediate 30 percent drop in prescriptions for Schedule II opioids, the most addictive, in patients with pain complaints, the study showed….
FDA Seeks Suspension of 4,402 Illegal Prescription Drug Websites
(Reuters)—The U.S. Food and Drug Administration said on Thursday it, along with international authorities, has formally sought to suspend 4,402 websites that illegally sell potentially dangerous, counterfeit or unapproved prescription drugs to U.S. consumers. The move is part of a global effort being led by the INTERPOL, the world’s largest police organization, to identify the…
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