Bioequivalency Drugs 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
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.
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Camargo
DECEMBER 13, 2021
Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.
pharmaphorum
JANUARY 18, 2023
NewAmsterdam Pharma’s bold play to resurrect an all-but defunct cholesterol-lowering drug class has been rewarded with a positive phase 2 trial of its oral CETP inhibitor obicetrapib. Amgen licensed the rights to NewAmsterdam in 2020. The post NewAmsterdam’s CETP renaissance gathers pace appeared first on.
FDA Law Blog
FEBRUARY 26, 2024
Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”
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. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.
The Pharma Data
AUGUST 5, 2020
The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults . Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. J Neurol Sci. 2003;206(2):165–71. 3. Bar-Or A, Fox E, Goodyear A, et al.
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