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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Development Bioequivalency Generic Drugs Production 242

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).

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Development Production Immune Response Licensing 161

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.

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Bioequivalency Trials Licensing Licensing 57

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.

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Production Bioequivalency Drugs Containment 59

XTalks

FEBRUARY 8, 2021

Last year, Biocon Biologics and Mylan announced they’d be seeking interchangeable status for their long-acting insulin product Semglee , developed to be an alternative to Sanofi’s Lantus (insulin glargine). Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product.

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Production Insulin Branding Generic Drugs 78

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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Trials Medicine Production Containment 52

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.

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