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Sanofi and Regeneron announce EMA acceptance for review of Marketing Authorisation Application for sarilumab

1 August 2016 | By Sanofi / Regeneron Pharmaceuticals, Inc.

Sanofi and Regeneron Pharmaceuticals, Inc. have announced that the European Medicines Agency has accepted for review the Marketing Authorisation Application for sarilumab, an investigational human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of adult patients with moderately to severely active rheumatoid arthritis...

FDA grants fast track for Shire’s NASH investigational treatment

29 July 2016 | By Mandy Parrett, Editorial Assistant

Shire Plc has announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults with nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Lab M launches MMGA pre-poured media plate

29 July 2016 | By

Lab M Ltd, a Neogen company, introduces its Pinnacle™ MMGA (ISO), Mineral Modified Glutamate Agar, pre-poured media plate. The new plate is formulation compliant to ISO 16649-1 and performance compliant to ISO 11133 for the recovery of stressed and injured E. coli in food, water and feed samples.

FDA grants QIDP for C. Difficile IV treatment

25 July 2016 | By Niamh Louise Marriott, Digital Content Producer

Morphochem announced today that the U.S. FDA has designated Morphochem’s intravenous antibacterial product as a Qualified Infectious Disease Product...