Regulatory

Dec 05, 2017
By BioPharm International Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Dec 04, 2017
By BioPharm International Editors
FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.
Dec 01, 2017
By BioPharm International Editors
In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.
Nov 21, 2017
By BioPharm International Editors
Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.
Nov 20, 2017
By BioPharm International Editors
The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.
Nov 10, 2017
By BioPharm International Editors
The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.
Nov 10, 2017
By BioPharm International Editors
The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
Nov 03, 2017
By BioPharm International Editors
FDA sent warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these statements.
Nov 01, 2017
BioPharm International
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
Oct 27, 2017
By BioPharm International Editors
The vaccine is approved for the prevention of shingles in adult patients aged 50 years and older.
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