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September 2023 Newsletter

Safe Biologics

View the full webinar here or watch individual segments linked below. 6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. Thanks to the IRA’s price controls, medical marvels like Keytruda will now be even more difficult to achieve. However, S.6

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November 2023 Newsletter

Safe Biologics

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars. Learn more about ACR Convergence 2023 here.

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October 2023 Newsletter

Safe Biologics

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. Watch clips from the webinar here.

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The rise of GLP-1 drugs: Transforming weight loss treatment

BioPharma Dive

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales.

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FDA approves KalVista’s Ekterly for hereditary angioedema

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.

Packaging 122
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Uruguay progresses towards developing its first regulatory agency

Pharmaceutical Technology

Advocates for the agency argue that while the opposing approach would streamline drugmakers’ access to the local market, it would not affect drug pricing, improve pharmacovigilance, bolster local manufacturing capacity or advance specific public health priorities. How will RFK Jr’s American dream for vaccines play out?

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Vertex wins European approval for Alyftrek, bolstering cystic fibrosis stronghold

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.