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In the News: October Regulatory and Development Updates

Camargo

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

Camargo

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. Product Type-Specific Analysis.

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NewAmsterdam’s CETP renaissance gathers pace

pharmaphorum

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.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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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

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. Poster presentation at: ACTRIMS; February 2020; West Palm Beach, FL.

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Cerelle vs Cerazette: Are they really the same?

Druggist

Do generic, and branded drugs produce exactly the same effect? . In terms of prescribing, both contraceptives are regarded as the same drug. . As with other drugs, once a patent expires, other manufactures start to produce generic or new brands of the same pill (desogestrel). Can I still request a doctor to prescribe Cerazette?

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

The Pharma Data

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.