Clearside Biomedical, Inc., a clinical-stage biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye, today announced Glenn Noronha, PhD, executive vice president of Research and Development of Clearside, will present at the 2015 International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) Clinical meeting in Berlin, Germany on Friday, July 10. Dr. Noronha’s presentation“Using suprachoroidal administration as an approach to treat noninfectious uveitis – from concept through clinical data” will be part of the afternoon Drug Delivery session.
Epic Sciences and LabCorp expand global reach with Asia clinical trials deal
Emily Wasserman / FierceDiagnostics
Last year, San Diego's Epic Sciences said it would team up with diagnostics luminary LabCorp ($LH) to make its tests available for European clinical trials. Now the companies are expanding their global footprint, extending their collaboration to provide Epic's tools for cancer clinical trials in Asia.
Epic Sciences (Epic) announced today an agreement with Laboratory Corporation of America® Holdings (LabCorp®) to provide circulating tumor cell (CTC) technology and support oncology clinical trials in Asia through Covance Drug Development (Covance). Covance will process patient samples in Singapore, and then send samples to Epic's clinical laboratory in San Diego, which has recently been licensed under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, for downstream detection and molecular characterization of CTCs. This agreement expands on a previous contract announced last year between Epic and LabCorp for European clinical trials.
Published Data Support Scientific Basis for Ganaxolone Use in PCDH 19 Female Epilepsy
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative neuropsychiatric therapeutics, today announced that Jozef Gecz, Ph.D., Professor of Human Genetics at the Department of Pediatrics, University of Adelaide, published data in the June issue of Human Molecular Genetics, supporting the role for neurosteroids in the pathophysiology of PCDH19 female epilepsy.
Celtaxsys, Inc., a clinical stage pharmaceutical development company focusing on anti-inflammatory therapeutics, including those with rare and orphan inflammatory disease indications, announced today that it has gained clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of its flagship drug candidate, acebilustat (CTX-4430), in adult CF patients in the US. The regulatory submissions to the health authorities in Europe will be filed soon after.
Research breakthrough to treat girls-only epilepsy
NewsMaker
An international team, led by a University of Adelaide genetics expert, has made a breakthrough discovery which is expected to help thousands of young girls worldwide who are suffering from a rare yet debilitating form of epilepsy.
Neothetics, Inc. (Nasdaq:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced the initiation of the post-treatment safety and duration of effect study, LIPO-202-CL-23, of LIPO-202, the first non-invasive injectable drug candidate for reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. This is a supplemental safety study that Neothetics expects to submit to the U.S. Food and Drug Administration ( FDA ) as part of the company's New Drug Application (NDA) package for LIPO-202, which the Company anticipates filing in the second half of 2016.
Tobira Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of novel treatments for liver and inflammatory diseases, announced today the addition of Ian Clements, Ph.D., to the company's leadership team as vice president, investor relations and corporate communications.
Clearside Biomedical, Inc. Announces Favorable End-of-Phase 2 Review with the FDA
Clearside Biomedical, Inc., a biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye, today announced a favorable End-of-Phase 2 review with the U.S. Food and Drug Administration (FDA) on its lead drug triamcinolone acetonide (TA) administered via injection into the suprachoroidal space (SCS) for the treatment of macular edema associated with non-infectious uveitis. Agreement was reached with the FDA for the overall development plan with a single pivotal Phase 3 clinical trial, and the company is finalizing plans to initiate this global study.
Syndax Pharmaceuticals, Inc., a privately held oncology company, announced today that Briggs W. Morrison, M.D. is joining the Company as Chief Executive Officer and a member of the Board of Directors, and that Michael A. Metzger is joining the Company as President and Chief Operating Officer. Dr. Morrison joins Syndax from AstraZeneca, where he was Executive Vice President, Global Medicines Development and Chief Medical Officer.
The RMI group has completed sertain projects
The RMI Group has exited from the capital of portfolio companies:
Marinus Pharmaceuticals, Inc.,
Syndax Pharmaceuticals, Inc.,
Atea Pharmaceuticals, Inc.