FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug.

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pharmaphorum

FEBRUARY 7, 2022

At the moment CAD is managed using off-label therapies, including rituximab and corticosteroid drugs, and sutimlimab’s potential to improve treatment earned it a breakthrough designation from the FDA. It also abandoned an mRNA-based vaccine for COVID-19 and suffered delays to another COVID-19 shot partnered with GlaxoSmithKline.

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PharmaShots

FEBRUARY 21, 2023

threshold by 2026. FAP-2286 (labeled with lutetium-177), a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP), is the company’s lead asset amongst radiopharma products.

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Pharmaceutical Technology

MAY 25, 2023

The ongoing Phase 1/2a ( NCT04725331 ) study is a multicentre, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with the anti-PD-1 treatment, Keytruda. Analysis estimates that the oncolytic virus market will reach $1 billion by 2026. Keytruda for the trial is provided by MSD (Merck & Co).

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pharmaphorum

NOVEMBER 6, 2022

The antibody-based drug has been cleared by the European Commission with a broad label, covering both full-term and pre-term babies and those with a range of health conditions that could make the vulnerable to RSV, said the two pharma groups in a statement. It is the first approval for Beyfortus (nirsevimab) by any regulatory authority.

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