Bio/Pharma News

Sep 27, 2018
By Pharmaceutical Technology Editors
The company’s biosimiliar to Amgen’s Neulasta (pegfilgrastim) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Sep 26, 2018
The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.
Sep 24, 2018
By Pharmaceutical Technology Editors
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval, including three orphan drug candidates.
Sep 20, 2018
By Pharmaceutical Technology Editors
BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.
Sep 20, 2018
By Pharmaceutical Technology Editors
The company announced it is creating a new Primary Care global business unit and a China & Emerging Markets unit.
Sep 20, 2018
By Pharmaceutical Technology Editors
The agency will review Praluent (alirocumab) Injection, a PCSK9 inhibitor, as a possible treatment of cardiovascular events.
Sep 14, 2018
By Pharmaceutical Technology Editors
Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.
Sep 14, 2018
By Pharmaceutical Technology Editors
The companies will develop therapies targeting the in-vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform.
Sep 10, 2018
By Pharmaceutical Technology Editors
The collaboration will explore the potential of Dyadic’s gene-expression platform to produce multiple biologic vaccines and drugs.
Sep 06, 2018
By Pharmaceutical Technology Editors
The purchase of Novartis’ cystic fibrosis products TOBI Podhaler and TOBI solution is expected to strengthen Mylan’s global respiratory portfolio.
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