Bioequivalency Development Licensing 
Drug Patent Watch
DECEMBER 12, 2024
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
Camargo
NOVEMBER 11, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. for patients with NTRK fusion cancer across all solid tumors.
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Camargo
DECEMBER 13, 2021
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).
pharmaphorum
JANUARY 18, 2023
Recently-listed NewAmsterdam is trying to succeed where a number of much larger drugmakers have failed – including Merck & Co , Pfizer, Eli Lilly, and Roche – which have all scrapped CETP development programmes following safety or efficacy issues. Amgen licensed the rights to NewAmsterdam in 2020.
FDA Law Blog
FEBRUARY 26, 2024
On February 23—the same day that the Agency licensed SIMLANDI (adalimumab-ryvk) Injection , the first interchangeable high-concentration, citrate-free biosimilar to HUMIRA, and that qualifies for First Interchangeable Exclusivity (“FIE”)—FDA denied the Boehringer Petition. FDA explained that its bioequivalence regulations at 21 C.F.R.
The Pharma Data
DECEMBER 17, 2020
With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. Patient enrollment of EXCELLENCE pivotal trial reaches 98%. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.
The Pharma Data
AUGUST 5, 2020
In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. J Neurol Sci. 2003;206(2):165–71.
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