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Tag: America

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Asterias to begin AST-OPC1 Phase I/IIa trial to treat spinal cord injury

The US Food and Drug Administration (FDA) has granted clearance to Asterias Biotherapeutics for the initiation of a Phase I/IIa clinical trial of its...

FDA plans to take steps to enhance the collection and availability of clinical trial data on demographic subgroups.

  By: Margaret A. Hamburg, M.D.Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration   August 20, 2014, Today...

Eli Lilly Humalog Manufacturing Facility

In April 2001 Eli Lilly announced it was constructing a new biotech bulk manufacturing facility in Carolina, Puerto Rico. Construction started in July 2002...

Uceris (Budesonide) for Treating Ulcerative Colitis

Uceris (budesonide) is glucocorticoid receptor that is indicated for the treatment of ulcerative colitis. It is developed by US-based biopharmaceutical company Santarus, in collaboration...

Afrezza – Mealtime Insulin Therapy for Diabetes

Afrezza is a rapid-acting insulin therapy indicated for controlling hyperglycaemia in adult patients with type 1 and type 2 diabetes mellitus. The drug is...

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Building the Right Team and Resource Model to Support Quality System and Validation Activities

Since life science quality and validation projects can vary...

Merck and Blackstone Enter R&D Funding Agreement for sac-TMT

Merck, recognized as MSD outside the U.S. and Canada,...

FDA Approves J&J’s DARZALEX FASPRO for HR-SMM in Adults

Johnson & Johnson said the U.S. Food and Drug...

FDA Approves UCB’s KYGEVVI for Thymidine Kinase 2 Deficiency

UCB, a leading global biopharmaceutical company, has announced that...

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