Regulatory

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.
Aug 28, 2018
By BioPharm International Editors
The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Aug 27, 2018
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
Aug 24, 2018
By BioPharm International Editors
Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.
Aug 23, 2018
By BioPharm International Editors
As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
Aug 23, 2018
By BioPharm International Editors
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
native1_300x100
lorem ipsum