NEW YORK (Reuters)—A U.S. judge has slashed a $500 million verdict against Johnson and Johnson and its DePuy unit over allegedly defective metal-on-metal Pinnacle hip implants to approximately $151 million. On Tuesday, U.S. District Judge Ed Kinkeade in the Northern District of Texas says he was compelled to reduce the verdict under a Texas state…
Infliximab Biosimilar Cross Reacts to Infliximab Antibodies; Plus Treat-to-Target Strategy Promising for Treating RA with bDMARDs
In a recent study, 100% of patients with rheumatoid arthritis (RA) on infliximab experienced a cross-reaction when switched to its biosimilar (CT-P13, infliximab-dyyb). Plus in a recent study, a treat-to-target strategy proved effective for treating RA with biological disease-modifying anti-rheumatic drugs…
Biosimilars: Unanswered Questions
Debate continues about how biosimilars that are emerging to treat rheumatic diseases will be named and monitored, said panelists at a recent meeting in Washington, D.C.—Biosimilars in the United States: Next Steps. Angus Worthing, MD, FACR, FACP, a member of the ACR’s Government Affairs Committee, shared rheumatologists’ concerns as these new therapies come to market….
Spanish Drugmaker Fears Disruption if EMA Moves from Britain
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Comment Period Open for FDA Draft Guidance on Osteoporosis Treatments; Plus FDA Rejects Abuse-Deterrent Apadaz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…
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