Allon Therapeutics Inc. said the FDA agreed to a special protocol assessment (SPA) for its drug candidate davunetide in progressive supranuclear palsy.

Results from two Phase III studies of nalmefene for alcohol dependence showed that some alcoholics really can quit any time they want. Nalmefene is a small-molecule opioid receptor antagonist that reduces an alcohol-dependent person's desire to drink. A unique feature of the drug in that therapeutic category is that abstinence from alcohol is not necessary for treatment success. Nalmefene is being developed by Biotie Therapies Corp., of Turku, Finland, and is licensed to H. Lundbeck A/S, of Copenhagen, Denmark.

In response to a blistering Institute of Medicine (IOM) report published in April 2010, the National Cancer Institute (NCI) will launch a major overhaul of its Clinical Trials Cooperative Group Program. The 50-year-old program conducts a large number of nationwide trials of new cancer therapies, but has not kept up with advances in molecular oncology. The report, which was requested by the NCI, also dinged the system for being inefficient, cumbersome, underfunded and overly complex – problems the agency will work to correct.

Cel-Sci Corp. began a carefully designed Phase III trial of Multikine, its investigational immunotherapy for head and neck cancer. Because Multikine is designed to recruit the support of a mostly healthy immune system, Cel-Sci is making a headlong charge at the goal of first-line therapy, instead of trying to develop the product in patients who have already received surgery, radiation and chemotherapy, and have suppressed or damaged immune systems as a result. If Cel-Sci can prove the therapy works in the narrow three-week testing window granted by the FDA, Multikine stands to replace a standard of care that has changed little in half a century.

Just in time for the New Year's weight loss resolution season, Sanford-Burnham Medical Research Institute and Takeda Pharmaceutical Company Ltd., of Osaka, Japan, have teamed up to tackle the growing, worldwide problem of obesity. Under terms of a new partnership agreement, which also includes Orlando-based Florida Hospital, the parties will pursue a bottom-up strategy of identifying metabolic pathways and signatures to develop new, more personalized treatments for obesity and its associated conditions.

Cephalon Inc. will not pursue approval of its sleep disorder drug Nuvigil (armodafinil) for jet lag following a second complete response letter from the FDA.

Adolor Corp. and Pfizer Inc. have discontinued a 2007 collaboration to develop Adolor's delta opioid receptor agonists, ADL5859 and ADL5747. The deal, originally valued at up to $265 million, fell apart when Phase II trial results in June failed to deliver any proof of efficacy in multiple indications including post-herpetic neuralgia. With the dissolution of the Pfizer deal, the delta opioid agonist program at Adolor also will be discontinued.

Sunesis Pharmaceuticals Inc. launched its Phase III trial of vosaroxin in combination with cytarabine in relapsed and refractory acute myeloid leukemia. The drug showed encouraging results from its Phase II studies, including excellent safety and tolerability in its sensitive elderly patient population.

Dazzled by science, Sanofi-Aventis SA, of Paris, plunked down $40 million in up-front cash and committed to as much as $770 million in milestones for collaborative access to Avila Therapeutics Inc.'s covalent drug discovery platform.