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...

Tolerx: Attacking the Cause of Type 1 Diabetes in People (Not Mice)

If you can still get excited about diabetes research headlines, then here’s some exciting news coming out of Cambridge, Mass, this week: Tolerx, a life sciences company, has reported they are in Phase 3 clinical trials for a new treatment of type 1 diabetes. If everything goes to plan, a representative of the company says,...

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...

Neuroscientist steers research into neurological disorders

Scientists at the Queensland Brain Institute have uncovered a vital clue into how the brain is wired, which could eventually steer research into nervous system disorders such as Parkinson's disease and cognitive disorders including...

Small molecule with high impact

Researchers from the vaccinology and applied microbiology department at the Helmholtz Center for Infection Research in Braunschweig, Germany, have now found a new molecule with the capacity of improving responses to vaccines. The synthetic compound, the so-called c-di-IMP, might be more than just a potent vaccine enhancer. The scientists expect to create new vaccination strategies based on c-di-IMP. The group's results have now been published in the current issue of the scientific journal...

Enanta Nominates EDP-239 as Lead Development Candidate for NS5A HCV Inhibitor Program

WATERTOWN, Mass., March 2 /PRNewswire/ -- Enanta Pharmaceuticals, Inc. announced today the nomination of lead development candidate, EDP-239, from its NS5A hepatitis C virus (HCV) inhibitor program. EDP-239 has demonstrated picomolar potency against multiple genotypes of the virus and a preclinical pharmacokinetic profile amenable to once-a-day...

Abbott and Enanta Announce Advancement of Hepatitis C Collaboration

WATERTOWN, Mass., March 2 /PRNewswire/ -- Enanta Pharmaceuticals, Inc. announced today the nomination of lead development candidate, EDP-239, from its NS5A hepatitis C virus (HCV) inhibitor program. EDP-239 has demonstrated picomolar potency against multiple genotypes of the virus and a preclinical pharmacokinetic profile amenable to once-a-day...

CombinatoRx scores $40M payout on FDA approval

CombinatoRx's complex merger deal with Neuromed will pay off with a $40 million milestone earned with today's announcement that the FDA has approved Exalgo, a once-daily pain therapy. Covidien, which partnered on the program, will handle the commercial rollout and fork over the...

National Cancer Institute awards PDS Biotechnology $1.28M phase 2 SBIR contract

PDS Biotechnology Corporation today announced that the company has been awarded a $1.28M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The contract provides funding to complete studies required to file an Investigational New Drug Application (IND) with the FDA for the company's lead human papillomavirus (HPV)-cancer product late in...