Monday, November 23, 2015
Janssen Pharmaceuticals has obtained worldwide rights, excluding China and Korea, to develop and commercialize oxyntomodulin-based therapies including HM12525A, a biologic that is completing phase I and expected to enter phase II studies next year, from Hanmi Pharmaceutical. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
Johnson & Johnson (J&J) has begun a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies. Trial recruitment is underway, and the first volunteers have received their initial vaccine dose. It is the first study conducted of Janssen’s Ebola prime-boost vaccine regimen in a West African country affected by the recent Ebola epidemic.
Canada-based biotech enGene, which has focused on development of therapeutics using its proprietary “Gene Pill” and enema gene delivery platform, has entered into a definitive agreement with Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize new therapies for inflammatory bowel disease (IBD).
Researchers funded by the NIH and the Foundation for the NIH (FNIH) have expanded a recently launched online library, called a knowledge portal, which allows open-access searching of human genetic and clinical information on type 2 diabetes. Individual data will remain confidential. The portal includes information from several major international networks, collected from decades of research.
Protectimmun, a Germany-based biopharmaceutical R&D company, has entered into a research funding agreement with Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Imperial College London. The research agreement, facilitated by Johnson & Johnson Innovation, will fund preclinical research conducted at Imperial College by professor Clare Lloyd with one of Protectimmun’s lead candidates in a proof-of-concept disease model of allergic asthma developed by Lloyd.
Mylan has been sued by BTG International, Janssen Biotech, Janssen Oncology and Janssen R&D in connection with the filing of an Abbreviated New Drug Application (ANDA) with the FDA for Abiraterone Acetate Tablets, 250mg. This product is the generic version of Zytiga, which is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.
Hybrigenics, a Paris-based biopharmaceutical company, has received Orphan Drug designation by the FDA for inecalcitol for the treatment of acute myeloid leukemia (AML) in the U.S. Orphan designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing.
Epizyme, a clinical stage biopharmaceutical R&D company creating novel epigenetic therapeutics for cancer patients, has announced Robert Bazemore will succeed Robert Gould, Ph.D., as president and chief executive officer of Epizyme, effective Sept. 10. Bazemore also will join the Epizyme board of directors. Following the transition, Gould will continue to sit on the board and work as a consultant to the company.
The Oxford Vaccines Group has initiated a phase II clinical study of the Ebola prime-boost vaccine regimen that combines Bavarian Nordic‘s MVA-BN Filo vaccine with the Ad26.ZEBOV vaccine from the Janssen Pharmaceutical Companies of Johnson & Johnson. The first volunteers have received their initial vaccine dose.