ROME, Italy—The traditional approach to trials to assess new biomarkers and related treatments has largely been inefficient, and a better strategy is needed to make stratified treatment available for patients more quickly, an expert said at EULAR 2015, the annual congress of the European League Against Rheumatism (EULAR). Mahesh Parmar, PhD, director of the Medical…
MUMBAI (Reuters)—The U.S. Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action. The FDA’s import alert on Mumbai-based Polydrug Laboratories Pvt Ltd’s Ambernath manufacturing plant comes two months after Canada banned the…
NEW YORK (Reuters Health)—Adding to earlier evidence, a new study finds kids with septic arthritis who are treated with dexamethasone recover faster. “We expected these results based on our previous randomized double-blind controlled study,” Dr. Itay Fogel from Schneider Children’s Medical Center of Israel and Tel Aviv University told Reuters Health by email. “However, the…
LONDON (Reuters)—Pfizer suffered a major setback in Britain on Thursday when the High Court in London ruled that claims of patent protection for the use of its $5 billion-a-year drug Lyrica as a pain treatment were invalid. Lyrica, known generically as pregabalin, was originally developed for epilepsy. However, further research showed it could also help patients…
NEW YORK (Reuters)—Pacira Pharmaceuticals Inc. on Tuesday filed a lawsuit seeking a court order allowing it to promote its post-surgery pain drug, Exparel (bupivacaine liposome injectable suspension), for a wide range of surgeries, which the U.S. Food and Drug Administration opposes. The lawsuit, filed in federal court in Manhattan, cites another New York judge’s recent…
(Reuters Health)—When patients have drug benefits that encourage them to save money by using certain pharmacies, they may end up filling more prescriptions, a company-funded study suggests. Narrow pharmacy networks that cover prescriptions only at certain retailers and drug benefits that offer consumers lower out-of-pocket fees at a subset of preferred pharmacies have become more…
BASEL (Reuters)—A regulatory backlog in developing countries including China has created wait times for drugs awaiting approval of up to seven years, Roche Holding AG Chief Executive Severin Schwan said on Tuesday. “Unfortunately, time lines are getting longer and longer in countries like China,” Schwan said at an oncology event at the Swiss company’s headquarters…
Comparing tacrolimus, mycophenolate mofetil and cyclophosphamide, tacrolimus was the most efficacious. Also, biosimilars may soon be easier to differentiate…
LONDON/ZURICH (Reuters)—Novartis kicked off a new era in U.S. medicine on Thursday with the launch of the first biosimilar copy of a biotechnology drug approved in the U.S., at a discount of 15% to the original. The Swiss drugmaker’s generics unit Sandoz said Zarxio, its form of Amgen’s white blood cell-boosting product Neupogen (filgrastim), would…
The FDA has fast-tracked the development of a drug to treat systemic sclerosis, or scleroderma; initial clinical trials started in June. Also, a major hospital group in France has selected the biosimilar infliximab to treat its patients with RA, Crohn’s disease and psoriasis…