R&D

GenSight Biologics Completes Enrollment of REVERSE Phase III Study of GS010 in the treatment of Leber’s Hereditary Optic Neuropathy

February 22, 2017

PARIS–(BUSINESS WIRE)–Regulatory News: GenSight Biologics (Paris: SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company that discovers and develops innovative gene therapies for neurodegenerative retinal diseases and diseases of the central nervous system, today announced that enrollment in REVERSE, a Phase III clinical trial of GS010 in the treatment of Leber’s Hereditary Optic Neuropathy […]

Ambry Genetics Launches New Site for Cohort Recruitment

February 22, 2017

ALISO VIEJO, Calif.–(BUSINESS WIRE)–Ambry Genetics (Ambry) has created an online portal to enable more patients and families to participate in research through the AmbryShare program. With this simplified portal, Ambry has streamlined the research consent process to make cohort recruitment easier for clinicians at the time of sample collection for clinical testing. “If your family […]

The Medicines Company Announces FDA Filing Acceptance of New Drug Application for Intravenous Antibiotic Carbavance® (meropenem-vaborbactam)

February 22, 2017

PARSIPPANY, N.J.–(BUSINESS WIRE)–The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s new drug application (NDA) filing for Carbavance® (meropenem-vaborbactam) for the treatment of complicated urinary tract infections (cUTIs). The FDA does not currently plan to hold an advisory committee meeting to discuss the […]

Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration

February 22, 2017

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that a Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “Based […]

FORMA Therapeutics Awarded Grant from The Michael J. Fox Foundation for Parkinson’s Research

February 22, 2017

WATERTOWN, Mass.–(BUSINESS WIRE)–FORMA Therapeutics, a clinical-stage and fully integrated discovery and development company, announced today it has been awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research (“MJFF”) to further develop FORMA’s discovery program in protein homeostasis and ubiquitination for the treatment of Parkinson’s disease (PD). FORMA has established a research […]

Envigo’s fully validated highly sensitive method enables completion of thyroid hormone tests in accordance with OECD guidelines

February 22, 2017

Princeton, NJ, USA, February 21, 2017. Envigo is pleased to announce that it has developed and validated a robust analytical method to evaluate the potential effects on thyroid hormone levels in rat F1 offspring. It is now possible for Envigo to successfully determine levels of T3 (triiodothyronine) and T4 (thyroxine) hormones in serum from rats […]

Lysogene Receives Orphan Drug Designation from EMA for LYS-GM101 for Treatment of GM1 Gangliosidosis

February 22, 2017

PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Regulatory News: “The EMA Orphan Drug Designation for LYS-GM101 is a key regulatory milestone further validating the medical plausibility of our approach” Tweet this Lysogene, (Paris:LYS) (the “Company” FR0013233475 – LYS) a leading, clinical-stage biotechnology company specializing in gene therapy for rare central nervous system diseases, today announces that the European […]

Frequency Therapeutics Announces a Revolutionary Small-molecule Approach to Restore Hearing Published in Cell Reports

February 22, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Frequency Therapeutics, a company spearheading the movement to restore hearing by harnessing the regenerative potential of progenitor cells in the body, today announced that a team led by Frequency’s scientific co-founders published research highlighting a breakthrough small-molecule approach to regenerate inner ear sensory hair cells. Frequency is advancing the approach to develop a […]

hVIVO notes the initiation of a Phase I clinical trial with AGS-v, a mosquito-borne disease vaccine candidate

February 22, 2017

LONDON, UNITED KINGDOM–(Marketwired – Feb 21, 2017) – hVIVO plc (AIM: HVO), a specialty biopharma company with discovery and clinical testing capabilities, notes the announcement from the US National Institute of Health (NIH) that it has initiated a Phase I clinical trial of AGS-v, an investigational mosquito-borne disease vaccine. AGS-v is intended to provide broad […]

Initial Results Positive for CelGro® in Human Nerve Regeneration

February 22, 2017

PERTH, Australia–(BUSINESS WIRE)–Regenerative medicine company Orthocell is pleased to announce positive initial safety and tolerability results for its CelGro® collagen-based medical device, in a clinical study examining its use to augment the repair of nerve damage. “This initial assessment is very positive and represents an important step forward in the development of CelGro® in the […]

Study Published in PAIN Reveals Nicotinamide Riboside is an Effective Tool in Relieving Chemotherapy-Induced Peripheral Neuropathy Induced by a Common Anticancer Agent

February 22, 2017

IRVINE, Calif., Feb. 22, 2017 (GLOBE NEWSWIRE) — ChromaDex Corporation (NASDAQ:CDXC) an innovator of proprietary health, wellness and nutritional ingredients that creates science-based solutions for dietary supplement, food and beverage, skin care, sports nutrition, and pharmaceutical products, announced today that University of Iowa researchers have published a study in the prestigious Journal of the International […]

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