Kite Pharma Inc. has moved to exclusively license two programs from an immunomodulatory technology developed by privately held Alpine Immune Sciences Inc. (AIS) as part of a new R&D agreement that includes $5 million up front and additional research funds.
Members of the FDA's arthritis drugs advisory committee on Friday voted 10-4 in favor of recommending that the agency approve a new drug application (NDA) for lesinurad, a gout drug developed by Astrazeneca plc subsidiary Ardea Biosciences Inc. to improve upon standard-of-care treatment for the condition.
Symphogen A/S has closed a €67.5 million (US$75.4 million) convertible debt facility from existing investors that will help the company advance its pipeline, led by Sym004, an antibody mixture currently in a phase IIb study for metastatic colorectal cancer (mCRC) patients with disease resistance or who are refractory to antibody therapies targeting epidermal growth factor receptor.
Two days earlier than expected, the FDA approved Merrimack Pharmaceuticals Inc.’s Onivyde (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin (LV), for patients with advanced pancreatic cancer previously treated with gemcitabine, giving the company its first ever U.S. drug approval.
SAN FRANCISCO – With seven consecutive quarters seeing more than $10 billion deployed to the start-up ecosystem, “it’s a great time to be an entrepreneur in America,” National Venture Capital Association president and CEO Bobby Franklin said recently. But try telling that to biotech companies seeking a series A today.
SAN FRANCISCO – With widespread excitement about immuno-oncology combinations driving deals, the pressure to find synergies has never been greater. The opportunities are creating new challenges for companies big and small, executives at the 2015 BIO Investor Forum said Tuesday.
Johnson & Johnson Innovation LLC's ongoing investment in Canada's drug discovery and development space has yielded two early stage deals for the company, both securing access to potential new assets for J&J unit Janssen Biotech LLC. A newly formed blood cancer drug developer, Novera Therapeutics Inc., stands to earn milestones of up to C$450 million (US$346 million) in one deal, while Engene Inc. could see up to C$441 million in milestones should Janssen embrace its non-viral vector for gene delivery to cells lining the intestine.
A fast-acting antidote for Boehringer Ingelheim GmbH’s blockbuster Pradaxa (dabigatran) won accelerated FDA approval Friday, becoming the first approved agent for reversing the widely used anticoagulant.
A partial clinical hold placed by the FDA on two Zafgen Inc. trials following a participant’s death continued to hold company shares (NASDAQ:ZFGN) near an all-time low Friday, pushing them $10.66 lower, or 50.7 percent, to close at $10.36.
Any questions lingering over Bristol-Myers Squibb Co.’s zeal for Five Prime Therapeutics Inc.’s lead colony-stimulating factor 1 receptor (CSF1R) antibody, FPA008, fell away as the pharma exercised its option to exclusively license the drug and other candidates in the CSF1R program, positioning Five Prime to earn up to $1.74 billion for FPA008, inclusive of a $350 million up-front payment, should a series of future events go its way.
