Israeli biotech Gamida Cell Ltd. moved lead product StemEx one step closer to becoming potentially the first allogeneic biologic cell product to achieve marketing approval in the U.S. and Europe. The therapy, which uses the company's copper chelator technology, demonstrated overall survival – the primary endpoint – in a Phase II/III study comparing its use in a transplantation regimen to historical controls when treating patients with hematologic malignancies such as leukemia and lymphoma who could not find a family-related matched bone marrow donor following myeloablative therapy.
Israeli biotech Gamida Cell Ltd. moved lead product StemEx one step closer to becoming potentially the first allogeneic biologic cell product to achieve marketing approval in the U.S. and Europe.
The move by six major drug discovery and development organizations to codify relationships that have existed for many years signals growing frustration in academia about the dearth of venture capital funding and big pharma support for early stage therapeutic development. Launch of the Global Alliance of Leading Drug Discovery and Development Centres represents a formal effort by the global institutions to collaborate on drug discovery projects of mutual interest and to improve the translational medicine hit rate.
A new collaboration among six of the world's largest translational research centers is designed to strengthen discovery efforts at academic and not-for-profit drug development institutes, ultimately improving the rate at which early stage technologies are advanced into commercial therapeutics.
Genentech Inc., a unit of the Roche Group, could add another agent to its formidable oncology arsenal if initial findings from a Phase III study of lead hematology candidate GA101 (obinutuzumab) are borne out in a three-arm trial.
After Tuesday's market close, Vertex Pharmaceuticals Inc. reported 2012 revenues of $1.53 billion, including net product revenues of $1.16 billion from Incivek (telaprevir) and $171.6 million from Kalydeco (ivacaftor), launched in the U.S. in February 2012.
Three weeks ago, Keryx Biopharmaceuticals Inc. CEO Ron Bentsur faced tough questions at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco about continuing delays in reporting long-term Phase III data on Zerenex (ferric citrate) for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) on dialysis.
Privately held Axerion Therapeutics Inc. hopes to translate two technologies exclusively licensed from Yale University into revolutionary therapeutics in a pair of indications – spinal cord injury (SCI) and Alzheimer's disease (AD) – that have bedeviled biotechs and big pharmas, alike.
Inspiration Biopharmaceuticals Inc., which filed for Chapter 11 bankruptcy in November 2012, and partner Ipsen SA unloaded their lead hemophilia program, OBI-1 (recombinant porcine factor VIII), to Baxter International Inc., which boasts the market-leading resume in the hemophilia space.
Anticipating a thumbs-up from the FDA on acute migraine drug Levadex and building from an existing co-promotion arrangement, Allergan Inc. is purchasing MAP Pharmaceuticals Inc. in a cash deal, acquiring the company's shares at $25 each.
