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.

Development 242

Development Bioequivalency Generic Drugs Production 242

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.”

Production 59

Production Bioequivalency Drugs Containment 59

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.

Development 161

Development Production Immune Response Licensing 161

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.

Trials 52

Trials Medicine Production Containment 52

Druggist

MARCH 25, 2021

Do generic, and branded drugs produce exactly the same effect? . Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen).

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

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. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. SOUTH SAN FRANCISCO, Calif.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40