BioPharm News

Jun 07, 2018
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
Jun 06, 2018
By BioPharm International Editors
The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.
Jun 05, 2018
By BioPharm International Editors
The agency has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen’s Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.
Jun 05, 2018
By BioPharm International Editors
The American Association of Pharmaceutical Scientists (AAPS) board of directors announced the candidates for the 2018 AAPS board.
Jun 04, 2018
By BioPharm International Editors
The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.
Jun 04, 2018
By BioPharm International Editors
The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.
Jun 04, 2018
By BioPharm International Editors
The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.
Jun 04, 2018
By BioPharm International Editors
EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.
Jun 04, 2018
By BioPharm International Editors
The FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.
Jun 01, 2018
By BioPharm International Editors
Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.
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