XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?

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Production Insulin Branding Generic Drugs 78

XTalks

JUNE 5, 2023

GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness. Patients and healthcare professionals should understand that certain semaglutide products may not contain the same active ingredient as FDA-approved semaglutide.

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XTalks

SEPTEMBER 28, 2023

This meant manufacturers could skip the FDA’s exhaustive safety review process, ensuring their products reached the market faster. Companies use the GRAS designation as a shortcut, introducing thousands of additives — some with known and unknown health risks — into American food products.

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Hormones Containment Production Cosmetics 52

XTalks

JANUARY 5, 2024

Related: Zepbound, Obesity Version of Eli Lilly’s Mounjaro, Finally Gets FDA Nod So far, LillyDirect provides support for 14 Lilly medicines, with 12 being different formulations and types of insulin. These updates may include new products, partners and services, such as programs to help patients with adherence to their medications.

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Drugs Pharmacy Cosmetics Insulin 59

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.

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Pharmacy Checkers

FEBRUARY 21, 2020

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

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Drugs FDA Approval Manufacturing Pharmacy 61

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. vs. $30 in the Canada.

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Pharmacy Drugs FDA Approval Licensing 41