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Latest From CIS bio international
US Marks Biologics Transition Day
Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.
Transition Day In The US: 96 Drugs Make The Move To Biologics Regulation
Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.
ViiV’s Potential HIV Blockbuster Among Latest Drugs To Win EMA Nod
A total of 13 new drugs have been recommended for pan-EU approval, while one has failed to meet the European Medicines Agency’s standards.
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In Vitro Diagnostics
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