Regulatory

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 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 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.
Sep 20, 2018
By BioPharm International Editors
The agreement now includes 15 European Union (EU) member states.
Sep 14, 2018
By BioPharm International Editors
The agency approved AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia.
Sep 10, 2018
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
Sep 01, 2018
BioPharm International
The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.
Sep 01, 2018
BioPharm International
This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
Aug 29, 2018
By BioPharm International Editors
PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.
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