Regulatory

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.
Sep 15, 2017
By BioPharm International Editors
European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.
Sep 15, 2017
By BioPharm International Editors
The approval marks the first biosimilar approved in the United States for treating cancers.
Sep 01, 2017
BioPharm International
Faced with divisive political and social issues, Congress must find a way to reach consensus.
Sep 01, 2017
By BioPharm International Editors
FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.
Sep 01, 2017
By BioPharm International Editors
A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.
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