Regulatory

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.
Oct 20, 2017
By BioPharm International Editors
This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.
Oct 16, 2017
By BioPharm International Editors
Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.
Oct 16, 2017
By BioPharm International Editors
The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.
Oct 13, 2017
By BioPharm International Editors
The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.
Oct 11, 2017
By BioPharm International Editors
AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.
Oct 11, 2017
By BioPharm International Editors
Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.
Oct 05, 2017
By BioPharm International Editors
Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.
Sep 27, 2017
By BioPharm International Editors
FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.
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