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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

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.

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Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

The Pharma Data

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.

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Cerelle vs Cerazette: Are they really the same?

Druggist

Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). A box of Cerelle or Cerazette pills comes with three blister blisters, each of which contains 28 mini-pills (note you may be prescribed just one blister = 28 pills). Both pills are taken in the same way.

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TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

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.