Clinical Trials
Alembic Pharmaceuticals receives USFDA Approval for Fenofibrate Tablets USP 48 mg and 145 mg
Alembic Pharmaceuticals Limited announced that the Company has received approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Fenofibrate Tablets USP, 48 mg and 145 mg. The approved ANDA is therapeutically equivalent to the reference...
Clinical Trials
Signant Health Launches Partner Program to Team with CRO’s Committed to Improving Clinical Trials with Patient Centric Technology
Signant Health , a leading provider of technology for clinical research, launches the Signant Health Partner Program, a significant investment the company is making to enable clinical research organizations (CROs) to better serve sponsors in the areas of Patient...
Clinical Trials
Amicus Announces Positive Interim Clinical Data for AAV Gene Therapy in Children with CLN6 Batten Disease
Amicus Therapeutics announced positive interim results from its CLN6 Batten disease gene therapy program licensed from the Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital. AWRI is conducting the ongoing Phase 1/2 clinical study of a single one-time...
Clinical Trials
GlycoMimetics Reports Top-line Results From Pfizers Phase 3 Clinical Trial Evaluating Rivipansel in Sickle Cell Disease
GlycoMimetics, Inc. reported that Pfizer Inc. announced that the Phase 3 Rivipansel (GMI-1070): Evaluating Safety, Efficacy and Time to Discharge (RESET) pivotal study did not meet its primary or key secondary efficacy endpoints.
The objective of the trial was to...
Clinical Trials
Sernova Phase I/II US Clinical Trial for Type-1 Diabetes Advances Following Positive Preliminary Safety and Efficacy Data
Sernova Corp, a clinical-stage regenerative medicine company announced that its human Phase I/II clinical trial for type-1 diabetes is advancing with additional patients for device and cell transplantation.
Sernova announced on July 3, 2019, a case study describing preliminary data...
Clinical Trials
Carolina Partners Clinical Research Institute, LLC, Announces Partnership to Provide Research as Care
Carolina Partners Clinical Research Institute, LLC, North Carolina’s largest outpatient mental and behavioral health practice, has partnered with Elligo Health Research, a healthcare-enabling research organization, to further expand its clinical research program. The partnership makes it possible for Carolina...
Clinical Trials
Orphazyme completes enrollment in phase 3 trial evaluating arimoclomol in amyotrophic lateral sclerosis
Orphazyme A/S, a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases announces that it has completed enrollment in its phase 3 trial evaluating arimoclomol for the treatment of Amyotrophic Lateral Sclerosis (ALS) ahead of schedule....
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