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Clinical Trials

Velesco Pharma set for clinical manufacturing capacity expansion

Pharmaceutical development and clinical manufacturing expert, Velesco Pharma, is set to triple its clinical manufacturing capacity with the purchase and fit-out of a new, state-of-the-art facility in Wixom, Michigan. The new building will feature expanded processing suite space to provide...

Tagrisso approved in China as a 1st line treatment for EGFR mutated non-small cell lung cancer

AstraZeneca announced that it has received marketing authorisation from China’s National Medical Products Administration (NMPA) for Tagrisso (osimertinib) as a 1st-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have the genetic mutations...

Thermo Fisher Scientific Announces Collaboration to Develop Advanced Analytical Workflows for Clinical Laboratories

Thermo Fisher Scientific, the world leader in serving science, and Cedars-Sinai, a leading nonprofit academic healthcare organization, have entered into a collaboration to develop a pathway to precision medicine through the development of robust, reliable and sensitive liquid chromatography...

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...

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...

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...

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...

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