Bristol-Myers Squibb Co., of Princeton, N.J., and AstraZeneca plc, of London, said the FDA accepted for review and granted priority designation for the biologics license application for metreleptin in metabolic disorders associated with inherited or acquired lipodsytrophy. Under priority review, the FDA aims to complete its review within an eight-month review cycle. Metreleptin, a recombinant analogue of human hormone leptin, was developed by San Diego-based Amylin Pharmaceuticals Inc., which

The following data were presented at the American Society of Clinical Oncology meeting in Chicago. Ambit Biosciences Corp., of San Diego, presented data from its Phase II ACE study of quizartinib (AC220), a FLT3 inhibitor, including data from 176 patients with either relapsed acute myeloid leukemia (AML) or AML that was refractory to second-line chemotherapy or hematopoietic stem cell transplantation (HSCT). Of the 136 FLT3-positive patients, 35 percent were bridged successfully to a

Aerial BioPharma LLC, of Morrisville, N.C., said data from a Phase IIa trial evaluating the efficacy and safety of ADX-N05 for the treatment of excessive daytime sleepiness in adult subjects with narcolepsy will be presented at the SLEEP 2013 meeting in Baltimore this week. A total of 33 patients were randomized and completed both N05 and placebo periods in the double-blind, placebo-controlled, multicenter, crossover study. The average sleep latency across the four trials on the Maintenance of

Some advisory committee members may think they're listening to a broken record when they convene for the third time in seven years Wednesday to once again discuss the cardiovascular (CV) risk of GlaxoSmithKline plc's (GSK) diabetes drug Avandia and its open-label, noninferiority RECORD trial. But this time, they'll be listening to a version conducted by the Duke Clinical Research Institute (DCRI), which was hired by GSK to satisfy the FDA's 2010 demand for an independent readjudication of the

Arcturus Therapeutics Inc., of San Diego, said it raised $1.3 million in a seed funding round led by multiple high net-worth private investors from the U.S. and Canada. The company was founded this year to pursue RNA interference solutions for rare diseases. Inflection Biosciences Ltd., of Dublin, Ireland, said it entered a license agreement with the Spanish National Cancer Research Centre (CNIO) for exclusive, worldwide rights to develop and commercialize several kinase inhibitors for the

LONDON – Bergenbio AS has raised $6 million in a Series B round supported by all the existing investors, providing funding for a number of Phase I trials of its lead product BGB 324, a first-in-class AXL receptor tyrosine kinase inhibitor. AXL kinase is central to the cell-to-cell signal transduction process known as epithelial-mesenchymal transition (EMT), by which cancer cells escape to form metastases and also is involved in the development of resistance to chemotherapeutics, most notably

CHICAGO – For those already cowed by the genetic diversity of cancer, Charles Swanton, of the Institute for Cancer Research/Royal Marsden Hospital, had some depressing news at the American Society for Clinical Oncology's (ASCO) annual meeting. Such tumor diversity, he told the audience at a joint ASCO/AACR session on metastasis, does not just exist between tumors in different patients. The differences between tumors and metastases, and even within different regions of the primary tumor, may

Much-awaited data from Synta Pharmaceuticals Corp.'s mid-stage GALAXY-1 study left investors less than satisfied, as shares of the Lexington, Mass.-based biotech dropped 34 percent. But the company said results from the study, presented Monday at ASCO 2013, confirmed the patient population selected for the recently initiated pivotal trial testing heat-shock protein 90 (Hsp90) inhibitor ganetespib as a second-line treatment in patients with advanced non-small-cell lung adenocarcinoma. Analysts

CHICAGO – From a scientific perspective, at least, the RTOG 0825 and AVAglio studies were a terrific success: they suggested plenty of avenues for future research. Clinicians, however, may be left scratching their heads about what the data mean for their patients. And so, in time, may the FDA. Both RTOG 0825 and AVAglio are Phase III randomized controlled trials looking at the effects of Avastin, (bevacizumab, Genentech/ Roche) in patients with newly diagnosed glioblastoma multiforme (GBM

Amgen Inc. didn't exactly take the blue ribbon for data on oncolytic immunotherapy talimogene laherparepvec, better known as T-VEC, at ASCO 2013. However, a first pass at key overall survival (OS) findings suggested the compound may still be in the mix for melanoma, though perhaps with a lower anticipated market opportunity than currently marketed Yervoy (ipilimumab, Bristol-Myers Squibb Co.) and highly anticipated PD-1 therapies. In March, Amgen reported the global, randomized, open-label

AbbVie Inc., of Chicago, reported results from a Phase I study of ABT-199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and relapsed/refractory non-Hodgkin's lymphoma (NHL). The Phase I, open-label, multicenter, international trial was designed to assess the safety, determine the maximum tolerated dose and recommended Phase II dose, and evaluate the pharmacokinetics of ABT-199 in

Renaissance Acquisition Holdings LLC, of Montreal, and GlaxoSmithKline plc, of London, entered an agreement giving Renaissance the rights in the U.S. to manufacture, market and sell six dermatology and three antiviral products from GSK. The products from GSK and Stiefel, a GSK company, which will be marketed through Renaissance's branded division Prestium Pharma, include: Evoclin (clindamycin phosphate) Foam; Extina (ketoconazole) Foam, Luxiq (betamethasone valerate) Foam, Olux (clobetasol

Acadia Pharmaceuticals Inc., of San Diego, said Allergan Inc., of Irvine, Calif., advanced an additional product candidate as a potential new treatment for glaucoma. The small molecule resulted from joint research conducted by the companies under their recently concluded research collaboration focused on new therapies for glaucoma and related ophthalmic conditions. Chimerix Inc., of Durham, N.C., said its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the

Analysts, inspecting early stage data, hailed the "paradigm-changing" potential in the treatment of at least one set of non-small-cell lung cancer (NSCLC) patients with Clovis Oncology Inc.'s oral CO-1686, for which results from Phase I/II trials were reported at ASCO 2013. Helped also by early data with an ovarian-cancer therapy, Boulder, Colo.-based Clovis' shares (NASDAQ:CLVS) blew through the roof, ending Monday at $74.59, up $38.01 , 104 percent, after trading as high as $86.29. The

While last year's American Society of Clinical Oncology (ASCO) meeting ended on cautiously encouraging advances in the cancer immunotherapy space, this year's meeting has put immunotherapy front and center, thanks in part to much-awaited data on and anti-PDL-1 and anti-PD-1 drugs from Roche AG and Bristol-Myers Squibb Co., respectively. (See BioWorld Today, June 6, 2012.) Those drugs, both check point inhibitors, generated significant buzz going into the ASCO meeting in Chicago. Between that

Shire plc, of Dublin, settled litigation against Teva Pharmaceuticals USA Inc., a division of Teva Pharmaceutical Industries Ltd., of Jerusalem, related to Teva's abbreviated new drug application for a generic version of Shire's Intuniv (guanfacince) for attention deficit hyperactivity disorder. The settlement allows Teva a license to market its own generic versions of Intuniv or authorized versions of Intuniv provided by Shire. As part of the settlement, Teva confirmed that its proposed

Alkermes plc, of Dublin, disclosed positive Phase II data with ALKS 5461, an opioid modulator, in patients with major depressive disorder and inadequate response to standard therapies. ALKS 5461 met its primary endpoint, met key secondary endpoints and demonstrated significant reduction in depressive symptoms versus placebo. The study was presented in an oral session at the 53rd Annual New Clinical Drug Evaluation Unit meeting in Hollywood, Fla. Bioheart Inc., of Sunrise, Fla., enrolled and