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. There are around 5,000 people with CAD in the US, according to Sanofi.

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pharmaphorum

AUGUST 27, 2020

Blenrep (belantamab mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can be used to treat the blood cancer in adult patients who have received at least four prior therapies. billion in 2026.

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The Checkup by Singlecare

MARCH 21, 2024

These findings have spurred further research, with ongoing clinical trials set to conclude in October 2026. Always consult a healthcare provider for the appropriate dosage, and closely follow their instructions for maximum safety and effectiveness, especially if you’re using the medication off-label for a condition other than diabetes.

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pharmaphorum

OCTOBER 1, 2020

Undeterred, CTI argued that it should move ahead with a filing based on additional data from an open-label study called PAC203, whilst also starting another phase 3 trial – PACIFICA – to bolster the data. Shortly after, Shire (now part of Takeda) ducked out of a $172 million partnership for the drug. Jakafi had sales of more than $1.1

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Pharmaceutical Technology

MARCH 7, 2023

Zulresso contains brexanolone, which is chemically identical to allopregnanolone, as per the drug’s label. With an estimated completion date of May 2026, the study strives to utilise the endocrine biology of perimenopause to explain the behavioural and neurobiological features of depression in perimenopausal women.

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Pharmaceutical Technology

JANUARY 10, 2023

Specifically, across all the major classes there are significant developments, label updates, and biosimilar launches that are driving their growth.

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ISPE

SEPTEMBER 29, 2023

By 2026, the site will produce 80% of its electricity consumed on-site and aims to be a net-zero greenhouse gas emissions site by 2030. Takeda has reduced CO2 emission by 861 tons. Over the past five years the entire Lessines production site has reduced its operational carbon footprint by 45% or the equivalent of 5,500 tons of CO2.

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European Pharmaceutical Review

NOVEMBER 24, 2022

With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.” Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

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The FDA Law Blog

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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The FDA Law Blog

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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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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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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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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