© 2022 MJH Life Sciences and Pharmacy Times – Pharmacy Practice News and Expert Insights. All rights reserved.
© 2022 MJH Life Sciences™ , Pharmacy Times – Pharmacy Practice News and Expert Insights. All rights reserved.
November 16, 2013
Steven Lucio of Novation discusses how Teva's Granix (tbo-filgrastim), which was filed through a 351(a) pathway, was approved for only 1 indication--and it was not the indication considered to be the "most definitive" for that particular product.
Aimee Tharaldson of Express Scripts explains why some hepatitis C patients who do not have signs of active disease may want to wait to receive treatment until later this year and early next year, when the FDA is expected to approve sofosbuvir and simeprevir for the treatment of this condition.
November 15, 2013
Manufacturing patents will play a larger role than molecule patents within the biologics development process, and these will also be a factor in terms of bringing complex products to market, argued Steven Lucio, senior director, Clinical Solutions and Pharmacy Program Development at Novation.
November 14, 2013
Dr. Morrow spoke on a panel last month with other representatives from Pharma at the Therigy Specialty Pharmacy Congress in Orlando, Florida. Here are some of the most notable comments he contributed to the discussion surrounding pharmaceutical manufacturers' outlook on specialty pharmacy.
Last year there were 11 new cancer drugs approved, and so far this year, 6 oncology medications have been approved, notes Aimee Tharaldson, PharmD, senior clinical consultant, Emerging Therapeutics, Express Scripts.
The process of adding biosimilars to formularies will be much more rigorous than what the industry is accustomed to seeing in the generic molecule space, asserted Steven Lucio, senior director, Clinical Solutions and Pharmacy Program Development at Novation.