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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. Broad label questioned. ICER points to brain swelling and potential bleeding seen in approximately 30% of patients treated with aducanumab.

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Biogen tweaks confirmatory trial of Alzheimer’s drug Aduhelm

pharmaphorum

Biogen and Eisai have increased the earning potential of their Alzheimer’s drug Aduhelm by expanding the post-marketing trial of the drug required by the FDA – which could be the primary source of income for the drug.

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What are authorized generics?

The Checkup by Singlecare

Food and Drug Administration (FDA), generic medications cost 80%-85% less than brand-name drugs. Chances are, you’ve taken a generic or authorized generic medication, and for good reason—according to the U.S. An estimated 90% of prescriptions filled in the United States are for commonly prescribed generic drugs.

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Transition Plans for Covid-19 Products are Amongst CDRH FY2023 Priorities

The FDA Law Blog

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. FDA published draft guidances for these topics in December 2021 ( here and here ).

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Does Zyrtec make you drowsy?

The Checkup by Singlecare

Food and Drug Administration (FDA) when proper dosage is followed. Always follow the instructions on the label for accurate dosing. Food and Drug Administration (2003) The post Does Zyrtec make you drowsy? How to use Zyrtec safely Zyrtec is considered safe by the U.S. appeared first on The Checkup.

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Is Mounjaro covered by Medicaid?

The Checkup by Singlecare

Mounjaro (tirzepatide) is an injectable medication prescribed for Type 2 diabetes mellitus, which some doctors may prescribe off-label for weight loss. Legislation passed in 2003 prohibits Medicare from covering drugs prescribed specifically for weight loss, and while Medicaid has more flexibility here, not every state will cover them.

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Does Medicare cover Ozempic?

The Checkup by Singlecare

Yet the Food and Drug Administration (FDA) hasn’t approved this GLP-1 agonist injection for weight loss. Instead, it’s FDA approved to improve glycemic control in adults with Type 2 diabetes and to reduce the risk of adverse cardiovascular events in adults with Type 2 diabetes and known heart disease.