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GoodBelly intorduces new digestive supplements
GoodBelly, a line of delicious probiotic drinks formulated for daily digestive health, is now making it even easier for consumers to achieve optimum intestinal balance with the debut of its new probiotic capsule: GoodBelly Probiotic Supplement.
Production & Manufacturing > OTC > News
GAT introduces new formulations for JetFuel Superburn and T-300 Products
GAT, a leading manufacturer of sport nutrition products, announced a nationwide re-launch of two of its key brand franchises. The JetFuel Superburn and T-300 products have been reformulated using rigorously tested ingredients and manufactured in a cGMP certified facility.
Production & Manufacturing > OTC > News
FDA grants orphan status for Protalex's PRTX-100 to treat immune thrombocytopenia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for Protalex's lead product, PRTX-100, for the treatment of immune thrombocytopenia (ITP), an autoimmune-mediated condition.
Regulatory Affairs > News
Ocular enrolls first patient in Phase III trial of Dextenza to treat allergic conjunctivitis
By PBR Staff Writer
US-based biopharmaceutical firm Ocular Therapeutix has started patient enrollment in a Phase III trial to evaluate the safety and efficacy of Dextenza to treat allergic conjunctivitis.
Contract Research & Services > Contract Research > News
Heron begins Phase II trial of HTX-011 to treat post-operative pain
By PBR Staff Writer
US-based biotechnology firm Heron Therapeutics has started a Phase II clinical trial of its lead product candidate, HTX-011, for the prevention of post-operative pain.
Contract Research & Services > Contract Research > News
West Pharmaceutical begins construction of new manufacturing facility in Ireland
By PBR Staff Writer
US-based West Pharmaceutical Services (WST) has started construction of its new pharmaceutical component manufacturing facility in Waterford, Ireland.
Production & Manufacturing > Manufacturing > News
Bayer, Johns Hopkins partner to develop new ophthalmic therapies
By PBR Staff Writer
Bayer HealthCare has entered into a five-year collaboration agreement with The Johns Hopkins University in Baltimore, US, for the discovery and development of new ophthalmic therapies targeting retinal diseases.
Drug Research > Drug Discovery & Development > News
Praxsyn executes new services agreement with NHS Pharma
Praxsyn Corporation's (PXYN) wholly owned subsidiary, Mesa Pharmacy (Mesa), announced that on June 9, 2015, it executed a new Services Agreement with NHS Pharma Sales, Inc. (NHS).
Contract Research & Services > Contract Services > News
Avalanche reports positive top-line Phase IIa results for AVA-101 in wet AMD
Avalanche Biotechnologies (AAVL) announced that its Phase 2a clinical study for AVA-101 met its 12-month primary endpoint, based on ophthalmic and systemic safety, demonstrating that AVA-101 was well tolerated with a favorable safety profile in subjects with wet age-related macular degeneration (wet AMD).
Contract Research & Services > Contract Research > News
ImmunoCellular enters into manufacturing agreement with PCT for US production of ICT-107
ImmunoCellular Therapeutics announced the selection of PCT, a subsidiary of Caladrius Biosciences (Caladrius) (CLBS), as the US manufacturer for ImmunoCellular's ICT-107 phase 3 registrational clinical program in newly diagnosed glioblastoma, anticipated to begin in the second half of 2015.
Production & Manufacturing > Manufacturing > News
PlasmaTech adds another AAV gene therapy program to product pipeline
PlasmaTech Biopharmaceuticals, a biopharmaceutical company focused on developing and delivering gene therapy and plasma-based products for severe and life-threatening rare diseases, announced that it has added another adeno-associated virus (AAV) gene therapy program to its product pipeline.
Contract Research & Services > Contract Services > News
Heavy hydrogen in living organisms may provide clues to prevent and treat cancer
Sub-molecular cellular events, driven by hydrogen’s replacements with deuterium, explain medical and economical failures of targeted molecular cancer drugs, which are the main conclusions of the 3rd International Congress on Deuterium Depletion held in Budapest, Hungary, in May 2015.
Production & Manufacturing > Manufacturing > News
Sucampo's IND for pivotal study of constipation drug Amitiza gets China FDA acceptance
By PBR Staff Writer
US-based Sucampo Pharmaceuticals has received accepted for its investigational new drug (IND) application from the China Food and Drug Administration (CFDA) for a pivotal study of Amitiza (lubiprostone) in patients with chronic idiopathic constipation.
Regulatory Affairs > News
Pfizer to expand caltrate and centrum production in China with new $95m production plant
By PBR Staff Writer
Pfizer has started construction of a new $95m production facility in Suzhou, China, to expand its production of Caltrate dietary supplements and Centrum multivitamins in the region.
Production & Manufacturing > OTC > News
Nutrinia's NTRA-9620 gets FDA orphan status to treat short bowel syndrome
By PBR Staff Writer
Israel-based Nutrinia has received orphan drug designation from the US Food and Drug Administration (FDA) for its orally-administered drug product, NTRA-9620, to treat short bowel syndrome (SBS), a malabsorption disorder, in patients of all ages.
Regulatory Affairs > News
136-150 of 47069 results