by Emily Burke, PhD | Mar 31, 2016 | Regulation
ADME: Absorption, Distribution, Metabolism, Excretion AE: Adverse Event ANDA: Abbreviated New Drug Application API: Active Pharmaceutical Ingredient ATMPs: Advanced Therapy Medicinal Products BLA: Biologic License Application BsUFA: Biosimilar User Fee Act CAT:...
by Emily Burke, PhD | Jan 7, 2016 | Regulation
Treatment Options Broaden Driven by 19 new orphan approvals, a whopping 45 novel drugs were cleared for the marketplace in 2015. Additionally, new approvals opened up treatment options for Americans with diseases ranging from breast and lung cancers to irritable bowel...
by Emily Burke, PhD | Mar 12, 2015 | Regulation
G-CSF: The original Innovator Sandoz’s (Princeton, NJ) Zarzio rode the first wave into the U.S. biosimilars market after it received FDA approval last week. Zarzio is similar to Amgen’s (Thousand Oaks, CA) Neupogen and both of these medications are...
by Emily Burke, PhD | Jan 15, 2015 | Regulation
Last week, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended Novartis’ biosimilar version of Amgen’s megahit Neupogen (filgrastim), effectively paving the way for the first US biosimilar approval in the near future. Filgrastim is a...
by Emily Burke, PhD | Jan 8, 2015 | Regulation
The FDA ushered in six new drugs just before the close of 2014, bringing the final tally to 41– the highest rate since 1996, when the agency approved 53 drugs. 2014 drug approvals were notable not only for their quantity, but also their quality. A number of new drugs...
by Emily Burke, PhD | Mar 13, 2014 | Regulation
ALPHABET SOUP: NEW DRUG APPROVALS Acronyms abound in the world of new drug approvals. Check out our cheat sheet below for help with some of the most common: BLA: Biologic Licensing Application Planning on developing a biologic drug? Would you like to bring it to...
