• Apeptico GmbH, of Vienna, Austria, said AP301, an orally inhaled peptide for edematous respiratory failure, was well tolerated in a Phase I trial. A Phase IIa trial with an aerosol formulation is slated to begin next year.• DelMar Pharmaceuticals Ltd., of Vancouver, British Columbia, initiated an open-label Phase I/II trial of VAL-083 for refractory glioblastoma multiforme. VAL-083 is a bi- functional alkylating agent approved in China for chronic myelogenous leukemia and solid tumors. Read More
• Acton Pharmaceuticals Inc., of Marlborough, Mass., completed a licensing agreement with Sanofi U.S., part of Paris-based Sanofi AS, for prescription Nasacort HFA (triamcinolone acetonide) nasal aerosol to treat nasal allergy symptoms. Acton assumes the exclusive U.S. rights to develop and market Nasacort HFA, an intranasal steroid formulated with a hydrofluoroalkane propellant and delivered as a dry mist in a volume-pressurized metered dose. Under the agreement, Sanofi retains all rights to Nasacort AQ. Read More
LONDON – ImmuPharma plc has pulled out of a $500 million cash deal for Lupuzor, over concerns that the lupus treatment would be beached following the acquisition of its licensee Cephalon Inc., by Teva Pharmaceutical Industries Ltd., which was finalized Oct. 14.London-based ImmuPharma is now scouting for a new partner for the drug, which is ready for Phase III. Read More
WASHINGTON – As the ball for the reauthorization of PDUFA bounces toward the congressional court, biopharma is keeping its fingers crossed that Congress doesn't interfere with the rules of the game that the FDA negotiated with industry over the past year.In urging Congress to act quickly to reauthorize PDUFA, the Pharmaceutical Research and Manufacturers of America (PhRMA) asked lawmakers to refrain from adding provisions that could delay the legislative process or create excessive regulatory burdens or uncertainty for the FDA, industry and other stakeholders. Read More
PHILADELPHIA – Finding new funding options in a tight financing environment has forced biotech companies to look beyond venture capital and piece together a patchwork quilt of angel investors, government grants, product partnerships and, in some cases, online investments, all in an effort to survive. Read More
Gilead Sciences Inc. and privately held GlobeImmune Inc. turned up the heat on an already sizzling hepatitis space by inking an exclusive worldwide license and collaboration to develop therapeutic vaccines that use Gilead's Viread (tenofovir disoproxil fumarate) and other oral therapies to treat chronic hepatitis B virus (HBV). Read More
Once again, Amgen Inc. beat analyst expectations for the quarter. The big biotech reported third quarter earnings of $1.40 per share, well ahead of the $1.29 per share expected by Wall Street.GAAP EPS was just 50 cents per share, however, thanks largely to a $780 million reserve Amgen established to settle various investigations into the sales and marketing of its erythropoiesis-stimulating agents (ESA). Chief Financial Officer Jonathan Peacock said the settlements should be finalized "over the next three to four months." Read More
SAN FRANCISCO – As hundreds of protestors gathered only a few streets away to oppose a fundraising luncheon for President Obama, biotech executives and investors gathered at the Palace Hotel were waging their own protest – albeit without signs and slogans – to the traditional drug development model. Read More
