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
By Peter Winter BioWorld Insight Editor While partnering strategies can provide access to essential products and technology, mergers and acquisitions can achieve the same goals and also provide greater leverage and control of the acquired assets. With a wide variety of biotech companies that have promising candidate products in late-stage clinical trials, and pharma companies still needing to tweak their product portfolios, the expectation is that the next big pharma acquisition of a biotech
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
By Mari Serebrov | BioWorld Today | Tuesday, June 4, 2013
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
By Nuala Moran | BioWorld Today | Tuesday, June 4, 2013
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
By Anette Breindl | BioWorld Today | Tuesday, June 4, 2013
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
By Jennifer Boggs | BioWorld Today | Tuesday, June 4, 2013
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
By Anette Breindl | BioWorld Today | Tuesday, June 4, 2013
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
By Marie Powers | BioWorld Today | Tuesday, June 4, 2013
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 $86.29. The
By Randy Osborne | BioWorld Today | Tuesday, June 4, 2013
Company (Location) Funding Institution Amount (US$M) Type Details Date MARCH Actinobac Biomed Inc. (New Brunswick, N.J.) National Institutes of Health $0.202 Grant To study its drug candidate, Leukothera, in B-cell lymphomas 3/29/13 Addex Therapeutics SA (Geneva) Michael J. Fox Foundation for Parkinson's Research $1 Grant To help fund continued human studies of dipraglurant in Parkinson's disease levodopa-induced dyskinesia 3/20/13 Atlantic Healthcare Ltd. (Cambridge, UK) UK's Technology
Epizyme Inc.'s initial public offering (IPO) hit the top end of the pricing range and added more than a million more shares than expected, with a next-day aftermarket performance that suggests enthusiasm about epigenetics will continue to grow. The Cambridge, Mass.-based firm, which had planned to sell about 4.29 million shares at a range of $13 to $15 each, placed about 5.9 million shares for $15 each, bagging about $77 million. Overallotments, if bought by underwriters would add about another
By Randy Osborne | BioWorld Today | Monday, June 3, 2013
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