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AstraZeneca starts Phase III program for asthma drug tralokinumab
By PBR Staff Writer
AstraZeneca has started the Phase III program for an investigational human monoclonal antibody tralokinumab, a potential treatment for patients with severe, inadequately controlled asthma, developed by the company’s global biologics research and development arm MedImmune.
Contract Research & Services > Clinical Trials > News
FDA approves B. Braun's Nutrilipid 20% for parenteral nutrition therapy
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved US-based B. Braun Medical's Nutrilipid 20% (IV fat emulsion) for parenteral nutrition therapy in adult and pediatric patients.
Production & Manufacturing > OTC > News
FDA grants fast track status for Agios's AG-221 to treat AML
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted Fast Track designation to US-based Agios Pharmaceuticals' AG-221, an oral, selective, potent IDH2 mutant inhibitor, to treat patients with acute myelogenous leukemia (AML) that harbor an isocitrate dehydrogenase-2 (IDH2) mutation.
Drug Research > Drug Discovery & Development > News
PuraMed completes first production of MigraPure gel
By PBR Staff Writer
PuraMed BioScience, a US-based researcher, developer and marketer of over the counter (OTC) medicinal and healthcare products, has completed the first batch production of its patented, sublingual MigraPure gel containing feverfew and ginger with an improved flavor.
Production & Manufacturing > OTC > News
TNI BioTech signs supplemental collaborative agreement with Hubei Qianjiang Pharmaceutical
TNI BioTech, a biotechnology company pioneering the manufacturing and marketing of innovative therapies for autoimmune diseases in emerging nations, has announced the signing of a supplemental agreement with Hubei Qianjiang Pharmaceutical Co., Ltd (600568.SS) ( Qianjiang) China on behalf of Cytocom, TNI BioTech's wholly owed subsidiary.
Drug Research > Drug Discovery & Development > News
BioCryst gets additional NIAID funding to advance development of BCX4430
BioCryst Pharmaceuticals has announced that the National Institute of Allergy and Infectious Diseases (NIAID) has exercised additional options to conduct Phase 1 clinical human safety trials of an intramuscular formulation of BCX4430, as well as efficacy studies in non-human primates to assess effective dose ranges and dose schedules.
Drug Research > Drug Discovery & Development > News
Horizon Pharma gets USPTO issues additional notice of allowance for VIMOVO
Horizon Pharma, has announced that POZEN, has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. patent application number 14/045,156 entitled "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs" that covers Horizon and POZEN'S U.S. approved product VIMOVO (naproxen / esomeprazole magnesium) delayed release tablets.
Production & Manufacturing > Process & Production > News
Ohr Pharmaceutical reports additional interim data from Phase II trial of Squalamine Eye Drops
Ohr Pharmaceutical, an ophthalmology research and development company, has announced additional interim data from the Phase II study evaluating Squalamine Eye Drops (OHR-102) for the treatment of the wet form of age-related macular degeneration ("wet-AMD").
Contract Research & Services > Clinical Trials > News
Reprogenetics expands to Southeast with Miami facility
Reprogenetics, the largest genetics laboratory in the United States specializing in Preimplantation Genetic Screening (PGS), the technique of examining the normal number of chromosomes in embryos, announced the grand opening of its new facility in Miami, Florida.
Contract Research & Services > Contract Research > News
Amgen issues voluntary recall of Aranesp (500 mcg) prefilled syringes outside US
Amgen has initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination. Lots 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B, 1047394A, 1047622A, and 1047996A are being recalled as a precautionary measure.
Production & Manufacturing > Manufacturing > News
RedHill Biopharma acquires option for Phase II pancreatic cancer drug RP101
RedHill Biopharma, an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, and RESprotect, a privately-held biotech company located in Dresden, Germany, have entered into a binding exclusive option agreement for the acquisition of the oncology drug candidate RP101 and next generation compounds.
Contract Research & Services > Contract Services > News
Allergan acquires worldwide rights of LiRIS program from TARIS Biomedical
By PBR Staff Writer
Allergan has closed a transaction to acquire worldwide rights to TARIS Biomedical’s (TARIS) lead program, LiRIS, being evaluate in Phase II trials to treat interstitial cystitis / bladder pain syndrome (IC/BPS).
Contract Research & Services > Contract Services > News
AstraZeneca releases top-line results from Phase III programme of lesinurad in gout patients
By PBR Staff Writer
AstraZeneca has released positive top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a combination therapy to treat patients with symptomatic gout.
Drug Research > Drug Discovery & Development > News
Sanofi launches generic version of Eloxatin
By PBR Staff Writer
Sanofi US, through its generics division Winthrop US, has launched an authorized generic version of Eloxatin (oxaliplatin injection).
Drug Research > Drug Delivery > News
European Commission approves Eylea to treat diabetic macular edema
By PBR Staff Writer
The European Commission has approved Bayer HealthCare's Eylea (aflibercept solution for injection into the eye) for the treatment of visual impairment due to diabetic macular edema (DME).
Drug Research > Drug Delivery > News
136-150 of 44868 results