Geron Corp.'s savior has arrived, with Janssen Biotech Inc. pledging $35 million up front plus $900 million in potential milestone payments for an exclusive license to the company's sole pipeline asset, imetelstat. Read More
LONDON – The EMA is without a leader after a court ruling annulled the appointment of the executive director, Guido Rasi, three years into his five-year term. Read More
With encouraging interim phase II data in hand and a large phase III trial under way, Celldex Therapeutics Inc. is making plans to talk with regulators about the chances for approval of rindopepimut (rindo), an immunotherapy vaccine targeting epidermal growth factor variant III (EGFRvIII) in glioblastoma multiforme (GBM). Read More
One way to prevent or get rid of viral infections may be to up the body's antibacterial defenses. That is the unexpected upshot of work published in the Nov. 14, 2014, issue of Science. Read More
Bristol-Myers Squibb Co., of New York, said it plans to build a large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland, that will produce multiple therapies for the company's biologics portfolio. Read More
Cytomedix Inc., of Gaithersburg, Md., said it is changing its corporate name to Nuo Therapeutics Inc., effective immediately. The wound care company's shares are now trading on the OCTQX platform as NUOT. Read More
Five Prime Therapeutics Inc., of South San Francisco, said healthy volunteers in its phase I trial of FPA008, a monoclonal antibody that inhibits colony stimulating factor-1 receptor, was well tolerated at doses associated with modulation of key biomarkers. The company said it is now ready to begin dosing patients with rheumatoid arthritis (RA) who are on on methotrexate to further assess tolerability and preliminary efficacy measures. Read More
PDL Biopharma Inc., of Incline Village, Nev., said it received $30.3 million, in addition to previously received revenue interest payments, to conclude PDL's revenue interest agreement with regenerative medicine company Axogen Inc., of Alachua, Fla. In October 2012, PDL entered a structured financing transaction in which it provided Axogen with an aggregate of $20.8 million in exchange for royalties on certain Axogen revenues. Read More
Fibrogen Inc. became the Street's new biotech sweetheart Friday, pricing its upsized initial public offering (IPO) of 8.1 million shares at $18 apiece, the high end of its range, to raise $145.8 million. The company could add another $21.9 million and become the largest U.S.-based biotech IPO this year, if underwriters fill a 30-day overallotment option to purchase an additional 1.2 million shares, eclipsing the $146.6 million raised by Santa Monica, Calif.-based Kite Pharma Inc. in its IPO. Read More
BEIJING – The cream of the crop in China's biotech world are quietly but surely developing strategies to bring their innovative assets to global markets. That was the message shared by Rick Sax, global head and senior vice president of clinical trials and reporting at Quintiles Transnational Corp., during the recent China Trials 7 conference, where he discussed what he terms a new China biopharma paradigm. Read More
LONDON – The race to deliver a commercial stem cell therapy for treating heart failure is heating up with two products now well advanced in phase III trials. However, the question of whether allogeneic or autologous cells represent the best approach remains unresolved. Read More
Researchers from the British Wellcome Trust Sanger Institute and University of Aberdeen have shown, in culture-free genome sequencing of the microbiome, contamination from both the kits used to prepare the samples and the laboratory equipment used to prepare it. Read More
