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...

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....

FDA proposes controversial release of complete response letters

After a long-simmering controversy over regulatory transparency, an FDA task force has proposed releasing its complete response letters to drug developers as part of a wide-ranging plan to let the sun shine in on safety issues, plant inspections and the agency's specific reasons for rejecting a new drug application. BIO has yet to respond to the set of 21 proposals assembled by an FDA task force headed by FDA Principal Deputy Commissioner Joshua Sharfstein. Despite some deep-seated reluctance...

Decree spells out $175M fine, new penalties for Genzyme

Genzyme said today that a draft consent decree sent by regulators would force it to hand over $175 million in profits earned from drugs made at its troubled Allston Landing manufacturing facility--a figure most investors seemed to find rather mild. Regulators also laid out a penalty of 18.5 percent of sales on products if it can't meet a set of deadlines for moving its fill/finish process out of the facility. Failure to meet compliance standards in 2011 and 2012 would trigger a fine...

Regulator notes potential cancer risk for weekly Byetta

A top regulator at the FDA has noted that data on the long-acting diabetes drug Byetta from Amylin and Eli Lilly indicate that the drug could be linked to a higher risk of cancer similar to that seen in Novo Nordisk's Victoza. Both are GLP-1 analogs. Analysts were quick to note that if the FDA responds with a black box warning on the risk, the companies were likely to see a slower uptake. The FDA temporarily delayed its decision on the once-weekly therapy after raising a few questions about the...