The FDA has approved new labeling for infused golimumab to include measures of mental and physical health. Plus romosozumab meets primary endpoints in postmenopausal women with osteoporosis during a Phase 3 trial…
Guselkumab Studied to Treat RA, Plaque Psoriasis
Guselkumab Studied to Treat RA & Plaque Psoriasis Guselkumab (GUS) is a subcutaneously administered monoclonal antibody that targets interleukin (IL) 23.1 It is being investigated in a Phase 2 study to treat rheumatoid arthritis (RA) and moderate to severe plaque psoriasis (PsA). On June 11, 2015, at the 2015 meeting of the European League Against…
XenoPort’s Psoriasis Drug Found Effective in Phase 2 Trial
(Reuters)—Drug developer XenoPort Inc. said on Tuesday its experimental drug was effective in treating psoriasis, sending its shares up 19% in premarket trading. The oral drug met the main goal in a phase 2 trial of patients with moderate-to-severe chronic plaque-type psoriasis, the company said. XenoPort said it expected to start late-stage trials next year…
EULAR 2015: Problems with Biomarkers
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…
U.S. Bans Another Indian Drug Plant over Production Quality
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…
More Evidence Dexamethasone Speeds Recovery in Kids with Septic Arthritis
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…
Pfizer Loses UK Patent Case over Use of Lyrica Drug for Pain
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…
Pacira Sues FDA over Pain Drug Marketing Restrictions
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…
Patients Steered to Fewer Pharmacies May Fill More Prescriptions
(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…
Regulatory Backlog in Emerging Nations Adding Years to Drug Approvals
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…
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