Dr. Kenneth Burhop is the chief scientific officer of Sangart Inc., a biopharmaceutical company that engages in the research, development, and commercialization of oxygen therapeutics. He joined Sangart in January 2011, after serving as the global scientific lead/CSO for Baxter Healthcare’s Medication Delivery division and VP of R&D for Baxter's Biopharmaceutical Technologies business, including the company’s second generation recombinant hemoglobin program. He has authored over forty publications, more than seventy abstracts, several book chapters, and has been invited to speak at various international meetings and symposia, and is a recognized international expert in the field of hemoglobin therapeutics. Burhop shares his opinions on clinical outsourcing.
How fast is fast enough? Time is money.
Clinical development involving rare diseases poses a unique set of medical, scientific, and operational challenges.
The primary objective of this study was to compare change in hemoglobin (Hb) from Baseline to the end of the study between the Q2W (every 2 weeks) and the Q4W (every 4 weeks) dosing regimens in subjects with anemia of CKD initiated on ERYTHROPOIETIN.
The clinical pharmacology team at ICON Development Solutions (ICON) has extensive experience in the design, study conduct and interpretation of clinical pharmacology studies across all major therapeutic areas.
Piramal Enterprises’ diagnostic division recently announced the launch of “QDx Instacheck” Right-here-Right-now.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the appointment of Lee F. Allen, M.D., Ph.D., as Chief Medical Officer. Dr. Allen will be responsible for leading the clinical development of Spectrum’s product pipeline, including belinostat, for which the Company anticipates an NDA filing mid-year, apaziquone, and glycol-free formulation of melphalan for both of which the NDA filings are expected in 2014. Dr. Allen brings over 15 years of biotech and pharma experience, as well as over 10 years of extensive research experience with over 40 papers published. He will report to Ken Keller, Executive Vice President and Chief Operating Officer. Spectrum also announced today that Dr. Steve Fruchtman, previously Chief Medical Officer at Spectrum, will take on the new role of Senior Vice President, Hematology and Oncology R&D, as of March 18, 2013. In this newly created position, he will report directly to Dr. Allen.
Concert Pharmaceuticals, Inc. announced today that it has completed enrollment of patients in a Phase 2 clinical trial evaluating CTP-499 for the treatment of diabetic kidney disease. CTP-499 is intended to slow progression of kidney damage in diabetic kidney disease and be additive to the current standard of care, which is treatment with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin receptor blocker (ARB). Concert expects to report top-line results from the Phase 2 study during the second-half of 2013.
Ablynx (EURONEXT BRUSSELS: ABLX) today announced efficacy and safety data for its anti-IL-6R Nanobody, ALX-0061, at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
Portola Pharmaceuticals, Inc. and Lee's Pharmaceutical (HK) Ltd. (
Amgen (NASDAQ:AMGN) today announced top-line results of the Phase 3 Aranesp® (darbepoetin alfa) RED-HF® (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial.
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today announced that the Company has initiated clinical trial sites and began enrolling patients in a Phase 3 clinical trial, known as PERSIST-1 or PAC325, for pacritinib, CTI's investigational JAK2 inhibitor, which is being evaluated for the treatment of patients with myelofibrosis.
Blinded Diagnostics announced the expansion of their business development efforts by appointing Patricia H. Averette, a seasoned health care professional with a solid background in Hematology Lab Diagnostics, as the new Vice President of Business Development.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that NCGS Incorporated has selected Merge’s eClinical OS™ and clinical trial management (CTMS) solution to streamline data management activity through electronic data capture (EDC) technology transfer and improve study management efficiency.
Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) announces today that Immunovative Therapies, Ltd. ("ITL") has been granted regulatory clearance from Thailand authorities to advance its lead AlloStim™ immunotherapy product candidate to the Phase II/III clinical development stage in advanced metastatic breast cancer.
Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators, announced today the initiation of a randomized, controlled, Phase 2 multi-center study of its investigational hematopoietic stem cell therapy, ProHema, in adult patients undergoing double umbilical cord blood transplantation (dUCBT) for hematologic malignancy.
Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN) announced today that its wholly owned subsidiary, Regen BioPharma, Inc., has contracted Cascade Life Sciences, Inc. to research the safety and efficacy of Regen's HemaXellerate™ product using mice models for testing
Bayer HealthCare today announced data from the Phase III CHEST-1 trial evaluating its investigational drug riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery.
Eli Lilly and Company (NYSE: LLY) today announced positive top-line results of three completed Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes.