Biotie Therapies Corp., of Turku, Finland, began a Phase II study evaluating nepicastat (SYN117) in cocaine dependence. The randomized, double-blind, placebo-controlled 11-week trial is expected to enroll about 180 treatment-seeking cocaine-dependent subjects at approximately 12 U.S. clinics and take approximately two years to complete. The National Institute on Drug Abuse at the National Institutes of Health is funding the study under a Collaborative Research and Development Agreement signed

Eli Lilly and Co., of Indianapolis, said the Phase III PRELUDE study of enzastaurin, which explored the molecule as monotherapy in preventing relapse in patients with diffuse large B-cell lymphoma, failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. Lilly said it will stop development of enzastaurin, a serine/threonine kinase inhibitor of the PKC beta and AKT pathways, and

Few of the pundits and tea-leaf readers handicapping the chances for approval of once-daily inhaled Breo (fluticasone furoate /vilanterol) in the wake of last month's FDA advisory panel were surprised by the agency's go-ahead for the chronic obstructive pulmonary disease (COPD) treatment from GlaxoSmithKline plc and Theravance Inc. Breo Ellipta, as the product is branded, will launch in the third quarter of this year. Theravance CEO Rick Winningham said his firm owes GSK a $30 million

The typical goal of stem cell therapies is to get the mature cells they produce to take up permanent residence in patients. But there is one therapeutic area where the opposite is true: Scientists are injecting stem cells that function as temporary drug delivery vehicles for brain tumors. "Over time, the cells tend to die off," Karen Aboody told BioWorld Today. But for this particular application, that lack of staying power is a strength, not a weakness. "We really only need our cells to be

Practically overnight, Affymax Inc. went from being lauded as a biotech success story and Wall Street darling to become one of the sector's biggest disappointments, and now, according to the latest 10-Q filing, the Palo Alto, Calif.-based firm might be nearing its end. Despite drastic cuts to its staff – 75 percent of employees were let go in March, and dates of separation are in the works for the remaining 25 percent, including the CEO and chief financial officer by June 15 – and restructuring

Salix Pharmaceuticals Ltd., of Raleigh, N.C., reported product revenue totaling $202.6 million for the first quarter, up 18 percent over the same period in 2012. Sales of antibiotic Xifaxan (rifaximin) reached $153 million. Non-GAAP net income was $40.1 million, or 63 cents per share, falling short of consensus estimates of 68 cents per share. Salix ended the first quarter with about $960.3 million on its balance sheet. Despite the earnings miss, the firm's shares (NASDAQ:SLXP) gained $2.99

Actavis Inc., of Parsippany, N.J., on Friday confirmed that it entered early stage discussions with Warner Chilcott plc, of Dublin, Ireland, regarding a potential combination of the two companies. The big pharma said no agreement has been reached and it does not intend to issue further comments. Several weeks ago, there were reports that Valeant Pharmaceuticals International Inc., of Montreal, was in talks to acquire Actavis. On Friday, Shibani Malhotra, an analyst with RBC Capital Markets LLC

Acceleron Pharma Inc., of Cambridge, Mass., said preclinical research conducted by Acceleron scientists on the ACE-536 program were presented at the 12th International Symposium on Myelodysplastic Syndromes in Berlin. Acceleron presented data on the effects of its investigational protein therapeutic, ACE-536, on correcting anemia and ineffective erythropoiesis in an animal model. Amgen Inc., of Thousand Oaks, Calif., and Zhejiang Beta Pharma Co. Ltd. formed a joint venture to commercialize

LONDON – Creabilis SA reported positive Phase IIb results for its topical TrkA kinase inhibitor CT327 in the relief of chronic pruritus (itch) caused by psoriasis, paving the way for a Phase III study designed to gain approval for treating itch in any dermatological disease. "We are delighted by the outcome," said Eliot Forster, CEO. "In addition to some benefits in terms of the underlying disease, CT327 showed a highly significant impact on itch, which in psoriasis and other dermatological

In a footnote to its recent 10-Q filing, Pfizer Inc. shared results of a March meeting with the FDA to discuss a June 2011 complete response letter (CRL) for Remoxy (oxycodone) saying that it may not continue development, and if so, it would not have a response to the CRL before mid-2015. Partners Durect Corp. and Pain Therapeutics Inc. both took major hits on Friday as a result: Durect (NASDAQ:DRRX) plummeted 54 cents, or 34 percent, to close at $1.05. Pain Therapeutics (NASDAQ:PTIE) fell $2

Discovery Laboratories Inc., of Warrington, Pa., said it priced a $14.25 million public offering of 9.5 million shares of common stock at $1.50, an 8.5 percent discount to Thursday's closing price. Net proceeds of about $13.2 million will be used primarily to support the commercial introduction of Surfaxin, its surfactant product approved last year for respiratory distress syndrome in premature infants, and the Afectair aerosol-conducting airway connector for infants, as well as for general

Thai Trial Analysis Shows Antibody Competition Follow-up analyses of the RV144 trial of Sanofi SA's ALVAC HIV and VaxGen Inc.'s AIDSVAX B/E HIV vaccine by a team from Duke University has provided evidence that the competition of two different types of antibodies may have lowered the efficacy of the vaccine. The RV144 trial was the first trial to provide any protection against HIV, but at a risk reduction of about 30 percent; that protection was not enough to justify going into large-scale

Acorda Therapeutics Inc., of Ardsley, N.Y., reported data from a preclinical study of dalfampridine for post-stroke deficits, showing that it improved motor function. The company previously completed a proof-of-concept study in humans that showed dalfampridine improved walking in people with post-stroke deficits. The data were published online ahead of print in Stroke and will be included in the July 2013 print edition. Dalfampridine is the active ingredient in Ampyra extended-release tablets

Adaptive Biotechnologies, of Seattle, entered a collaboration with Bristol-Myers Squibb Co., of New York, for the discovery of immunological biomarkers in oncology. Under the terms, Adaptive will use its immune profiling assay, immunoSEQ, to identify potential biomarkers that may inform about drug response. Financial terms were not disclosed. Merck & Co. Inc., of Whitehouse Station, N.J., is facing a $100 million individual and class-action suit filed by Sanford Heisler LLP on behalf of all

Trevena Inc.'s deal with a subsidiary of Forest Laboratories Inc. brings a $30 million equity investment in exchange for an option to license worldwide rights to TRV027, an angiotensin II Type I receptor (AT1R) biased ligand for acute decompensated heart failure (ADHF), after results are clear from a 500-patient Phase IIb trial, slated to begin by the end of the year. If the option is exercised, New York-based Forest will make payments of up to $430 million, depending upon the achievement of

Hours after reporting its first quarterly earnings as a commercial entity following FDA approval of Kynamro (mipomersen) in January and subsequent launch of the antisense drug, Isis Pharmaceuticals Inc. turned its attention to other candidates in its pipeline. The Carlsbad, Calif.-based company priced an underwritten public offering of 9 million shares of its common stock at $19 per share, seeking to raise $171 million from the offering, which is expected to close on or about May 14. Isis

Acucela Inc., of Bothell, Wash., and Otsuka Pharmaceutical Co. Ltd., of Tokyo, reported results of a Phase IIa trial of emixustat hydrochloride for geographic atrophy (GA) of dry age-related macular degeneration at the Association for Research in Vision and Ophthalmology meeting in Seattle. The objective of the 72-patient study was safety and tolerability of emixustat hydrochloride doses in subjects with GA compared to placebo. Biological activity of emixustat hydrochloride in the retina also