A parade of three dozen physicians, nurses, patients, advocates and family members overwhelmingly endorsed the continued availability of Avastin (bevacizumab) for metastatic breast cancer during the first day of the FDA's unprecedented hearing on its proposal to withdraw the drug's approval for the indication. But in a slew of legal and scientific data, representatives from the FDA's Office of New Drugs and Center for Drug Evaluation and Research laid the groundwork for an unflinching rejection of the request by Genentech Inc., of South San Francisco, and parent company Roche AG, of Basel, Switzerland, to continue marketing the drug for metastatic breast cancer while Genentech pursues new studies to support Avastin's use in the indication. Read More
With early stage venture funding hard to come by, Acetylon Pharmaceuticals Inc. has found an alternative way to fund its development of isoform-selective histone deacetylase (HDAC) inhibitors. The Boston-based biopharma has raised $27 million in Series B financing from a large contingent of private individuals. Read More
WASHINGTON – An international consortium is about to launch with an ambitious target to develop diagnostics for the majority of the 8,000 known rare diseases and to increase the number of registered drug treatments available for these conditions from 200 currently to 400 by 2020. Read More
WASHINGTON – Getting funding for candidates beyond the lead compound continues to be a challenge for platform companies with multiple programs. Where's the money coming from today – venture capital, partners, government grants, sovereign funding or foundation support? Read More
WASHINGTON – For drug development firms trying to save money or playing catch-up in a highly competitive field, it might seem a good idea to skimp on Phase II testing by enrolling fewer patients, conducting only one midstage study or even leapfrogging straight to Phase III and hoping that the efficacy signal observed in Phase I wasn't just a fluke. Read More
WASHINGTON – Most biotech start-ups, even the most successful, will at some point hit a cash flow wall, where they need a large infusion of funding to get a product to the regulatory finish line. Recent economic trends have largely taken the initial public offering (IPO) option off the table, so for most companies the choice comes down to partnering or acquisition. At BIO 2011, Calistoga Pharmaceuticals Inc. CEO Carol Gallagher and Athersys Inc. CEO Gil Van Bokkelen discussed how they arrived at the decision to partner or sell. Read More
WASHINGTON – Even before overcoming the safety, efficacy and approval hurdles, biotechs should be looking ahead to the fourth hurdle – reimbursement. Read More
Among the data to be presented at the American Diabetes Association's annual meeting this week were additional analyses of Rockville, Md.-based MacroGenics Inc.'s anti-CD3 antibody teplizumab. Read More
Theratechnologies Inc., of Montreal, reported that the marketing authorization application (MAA) for tesamorelin submitted by its partner, Ferrer Internacional SA, of Barcelona, Spain, was accepted for review by the European Medicines Agency. The MAA is based on positive results from two Phase III trials that enrolled more than 800 patients and follows tesamorelin's marketing approval by the FDA in November 2010 under the trade name Egrifta. Tesamorelin is designed to treat HIV-associated lipodystrophy, a metabolic complication that affects patients taking antiretroviral therapies long term. Read More
WASHINGTON – As the financing track kicked off with its first BIO2011 session in a crowded room at the Walter E. Washington conference center, the focus was on how to access National Institutes of Health (NIH) grants and other funding sources to get early stage research across the so-called Valley of Death. Read More
WASHINGTON – Compared with the abbreviated new drug process, the biosimilar pathway looks like an intricately choreographed dance of notification, disclosure and negotiations between the innovator and the follow-on. Read More
