PhysioGenix’s Substantial Growth in 2010 Expected to Continue in 2011

PhysioGenix experienced a tremendous year through the completion of a new research facility, addition of capabilities and record high sales. Milwaukee, WI (PRWEB) March 23, 2011 -- PhysioGenix, already a leader in customer focused contract research, expanded their research facilities, capabilities and research models in 2010. “We experienced tremendous growth in 2010 and anticipate additional growth in 2011,” stated PhysioGenix’s Director of Sales Darin Evans. PhysioGenix was a...

U.S. Scientists Contribute to Japan Earthquake and Pacific Tsunami Relief Effort

PhysioGenix, a diabetes and cardiovascular Preclinical Contract Research Organization, donates money to the American Red Cross to aid in the Japan earthquake and Pacific tsunami relief effort. Milwaukee, WI (PRWEB) March 20, 2011 -- PhysioGenix has donated to the American Red Cross to help provide relief for the recent earthquake and tsunami victims. PhysioGenix has been in e-mail contact with several of their Japanese colleagues who have informed them that they and their families are all...

FDA staffers weighs risks, rewards of new epilepsy drug

Staffers at the FDA have red-flagged their concern about cases of urinary retention tracked in some patients taking Valeant Pharmaceutical's experimental new epilepsy medicine Potiga (ezogabine), which comes before an advisory panel on Wednesday. But the staff review also noted that the drug appears to be effective and most cases of an inability to urinate were reversible. Valeant is looking for an FDA approval to use the medicine as part of a combinational approach to...

AZ’s blockbuster Brilinta wins landslide FDA panel vote

AstraZeneca scored a big win in front of an FDA advisory panel on Wednesday afternoon, gaining solid support for its blockbuster blood thinner Brilinta in a seven-to-one vote in favor of approval. AstraZeneca's biggest obstacle was the relatively small contingent of 1,413 American patients in a large international Phase III who failed to benefit from the drug. But the 17,000 patients who participated in the study in 42 other countries demonstrated a sharp drop in deaths and heart attacks,...

Think tank: Let EMA-approved drugs onto U.S. market

Over the last two years the EMA and the FDA have approved a total of 39 new drugs. But 11 of those drugs are only available in Europe, where regulators also scored significantly faster approval times, shaving 97 days off the FDA average. And those stats spurred a think tank called the Pacific Research Institute to suggest that the U.S. would be far better off if it allows pharma companies the right to go ahead and start marketing drugs here once they get an approval over there. "Clearly,...

Feds reviewing new R&D incentives for rare diseases

Charged with spurring greater R&D efforts on new drugs for rare diseases, the FDA's newly formed rare disease review group plans to meet today and tomorrow, when it will hear about a host of new ideas on a richer set of research incentives. Earlier this year the FDA and the NIH announced one initiative aimed at encouraging early studies on new therapies for rare diseases, which has been the subject of growing industry interest with the launch of special units devoted to the field at...

FDA delays decision on AZ’s motavizumab

AstraZeneca's (NYSE: AZN) MedImmune unit has received word from the FDA has delayed decision date for its review of motavizumab, an investigational monoclonal antibody being considered to help prevent serious respiratory syncytial virus, from June 24 to Aug. 27. AZ is hoping that the experimental drug, which had been in MedImmune's pipeline as a successor to Synagis, wins approval. But these hopes may be dashed, especially after a 14 to 3 vote by an FDA...

PhysioGenix Releases Free Online Study Design Tool

Milwaukee, WI (PRWEB) June 17, 2010 -- PhysioGenix, Inc. - http://www.physiogenix.com - a leading preclinical CRO, has launched a free web application to aide the study design, planning, and execution. The online tool will allow researchers to hand pick different aspects of a study, from endpoints, assays, tissue samples, and more. PhysioGenix is currently looking for beta users to try out the newly built tool. Feel free to visit http://physiogenix.com/sign-up to register to use this free study...

Big Pharma coalition will pool data on failed Alzheimer’s drugs

Johnson & Johnson, GlaxoSmithKline, AstraZeneca, Sanofi-Aventis and Abbott Labs are releasing results from 11 failed Alzheimer's programs with the hope that the information will help researchers better understand the disease. Alzheimer's is a difficult-to-treat condition and clinical successes are few and far between. More drugmakers, along with the National Institutes of Health, plan to join the coalition in the future. The project is backed by the FDA and Science Foundation...

FDA wants preclinical data on XenoPort’s Horizant

Shares of XenoPort were buoyed by the news that regulators had asked for preclinical data on its experimental therapy for restless leg syndrome but were not asking for any new trials. XenoPort plans to file a complete response to the FDA in the second half of the year. "We believe this is an incremental positive for the company as a path toward an approval of Horizant has been identified," said Leerink Swann analyst Steve Yoo....