BioPharm News

Sep 27, 2018
By BioPharm International Editors
The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.
Sep 27, 2018
By BioPharm International Editors
The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.
Sep 27, 2018
By BioPharm International 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 27, 2018
By BioPharm International Editors
GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.
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 26, 2018
By BioPharm International Editors
The National Institute for Health and Care Excellence recently rejected National Health Service’s funding of Kymriah for diffuse large B-cell lymphoma (DLBCL) despite recognizing that the drug has significant clinical benefits.
Sep 25, 2018
By BioPharm International Editors
Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 9, 2018.
Sep 24, 2018
By BioPharm International Editors
FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.
Sep 24, 2018
By BioPharm International 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 21, 2018
By BioPharm International Editors
The European Medicines Agency has recommended Luxturna (voretigene neparvovec) as the first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene.
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