humanized interleukin-6 receptor antagonist Polyarticular juvenile idiopathic arthritis FDA approved it 5/1/13 MISCELLANEOUS Amgen Inc. (Thousand Oaks, Calif.) Neupogen Granulocyte colony-stimulating factor Radiation sickness FDA advisory committees voted that data from an NIH-sponsored animal study were sufficient to approve Neupogen and could be applied to all drugs in the same class 5/7/13 Biomarin Pharmaceutical Inc. (San Rafael, Calif.) Vimizim BMN-110, elosulfase alfa

Salix Pharmaceuticals Ltd., of Raleigh, N.C., and Progenics Pharmaceuticals Inc., of Tarrytown, N.C., said the FDA will hold an advisory committee meeting to review Salix's supplemental new drug application (sNDA) for Relistor (methylnaltrexone bromide) subcutaneous injection in opioid-induced constipation (OIC) for patients with chronic pain

Acknowledging that the train may have already left the station for Glaxosmithkline plc's (GSK) Avandia, some advisory committee members and other experts looked down the track last week to give the FDA an earful on how to get more meaningful data about diabetes drugs and avoid the process that derailed the one-time blockbuster Avandia...Ideally, data should come from randomized, controlled, double-blind, superiority trials – not from meta-analyses and observational studies, which can be loaded with

That decision was made in the wake of the FDA's Oncology Drugs Advisory Committee (ODAC) 13-1 vote against the adequacy of Aveo Pharmaceuticals Inc.'s tivozanib, an inhibitor of all three vascular endothelial growth factor receptors, in renal cell carcinoma (RCC

The FDA reasonably understands that a safety study designed to include, say, 30,000 patients is not economically feasible for a small company like Dynavax," he told investors, stating that the scale likely would be more along the lines of what was suggested during last year's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting

In the wake of the FDA's Oncology Drugs Advisory Committee (ODAC) 13-1 vote against the adequacy of AVEO Pharmaceuticals Inc.'s tivozanib, an inhibitor of all three vascular endothelial growth factor (VEGF) receptors, in renal cell carcinoma (RCC) there were several losers: patients, the company and its staff

Chronic fatigue syndrome (CFS) has been at the center of a vortex of controversy since the FDA handed down a complete response letter on the Toll-like receptor 3 modulator Ampligen (rintatolimod) from Hemispherx Bioscience Inc. – the only drug in development for CFS – despite the impassioned pleas of patients at an Arthritis Advisory Committee meeting in December 2012. (See BioWorld Today, Dec. 21, 2012, and Feb. 6, 2013.) Although pressure from those patients and from the Chronic Fatigue and

A replay of the data from the RECORD trial seemed to reassure many members of two FDA advisory committees about the use of GlaxoSmithKline plc's diabetes drug Avandia, but they admitted that it's probably too late to rehabilitate the drug's reputation...After a two-day meeting that looked at independently readjudicated results from the open-label RECORD trial, seven members of the Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees voted that restrictions

Some advisory committee members may think they're listening to a broken record when they convene for the third time in seven years Wednesday to once again discuss the cardiovascular (CV) risk of GlaxoSmithKline plc's (GSK) diabetes drug Avandia and its open-label, noninferiority RECORD trial...To shed more light on the data behind those views, the agency will ask the advisory committees once again to discuss whether the results of the RECORD trial are reliable and interpretable

The CRL came as no surprise because the modest reduction in menopause-related vasomotor symptoms recorded in three Phase III trials was not sufficient to warrant the side-effect risk associated with gabapentin, according to the FDA's Reproductive Health Drugs Advisory Committee, which voted in March 12-2 to recommend against Sefelsa (formerly Serada). (See BioWorld Today, March 5, 2013

Norgine BV, of Amsterdam, the Netherlands, said the Australian assessment body, the Pharmaceutical Benefits Advisory Committee, recommended the use of non-antibiotic antibacterial drug Xifaxan 550 mg in the prevention of the recurrence of hepatic encephalopathy where other treatments have failed or are contraindicated

The move comes less than a month after the FDA's Oncology Drugs Advisory Committee (ODAC) voted against the adequacy of tivozanib in RCC based on a single Phase III trial...Norgine BV, of Amsterdam, the Netherlands, said the Australian assessment body, the Pharmaceutical Benefits Advisory Committee, recommended the use of non-antibiotic antibacterial drug Xifaxan 550 mg in the prevention of the recurrence of hepatic encephalopathy where other treatments have failed or are contraindicated

Inc., of Whitehouse Station, N.J., said the FDA Peripheral and Central Nervous System Drugs Advisory Committee voted in favor of the firm's low-dose sleep aid, suvorexant, to treat insomnia

McCleary, in Washington this week at a federal CFS advisory committee meeting (not the same as an FDA adcom), noted that Jody Roth, director of regulatory affairs for Indianapolis-based Eli Lilly and Co., spoke during the final panel of the workshop, held April 25 and 26

Baliopharm GmbH, a subsidiary of Baliopharm AG, of Basel, Switzerland, joined the NEU2 Consortium with a project addressing the recombinant manufacturing of an Fc-free bispecific CD20-CD95 antibody construct (Novotarg) with selectivity for activated B cells and efficacy studies in disease models relevant to multiple sclerosis therapy. The two-year project was funded by the German Federal Ministry of Education and Research. Bayer AG, of Leverkusen, Germany, signed an agreement to acquire the

QRxPharma Ltd., of Sydney, Australia, said the FDA set an advisory committee meeting July 17, to consider the firm's resubmitted MoxDuo new drug application

The action comes less than a month after the FDA's Pulmonary-Allergy Drugs Advisory Committee bestowed its less--than-thunderously unanimous favor on Breo...Balloting by the adcom totaled 12-1 in favor of Breo's efficacy as a maintenance therapy, 8-5 in favor of efficacy for exacerbations and 10-3 positive for safety. (See BioWorld Today, April 18, 2013.) "Walking out of the advisory committee, I felt quite optimistic about the outcome" at the FDA, mainly because of the amount of work that both

Discussion at the joint meeting of the Oncologic Drugs and the Medical Imaging Drugs advisory committees also could open the medical countermeasure (MCM) door for future biosimilars...The two FDA advisory committees told the agency that the data should be applied to all drugs in the same class