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In the News: October Regulatory and Development Updates

Camargo

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. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning.

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Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. billion, three biosimilar products in development targeting products with a market size of approximately $13.0

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The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products.

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Cerelle vs Cerazette: Are they really the same?

Druggist

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). In terms of prescribing, both contraceptives are regarded as the same drug. . Cerelle vs Cerazette: are they the same?

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

The Pharma Data

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches. Cautionary Note on Forward-Looking Statements. Source link.