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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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 Checkup by Singlecare

AUGUST 1, 2024

holds the patent for Trintellix, which is expected to expire in 2026, when a generic version may become available. In addition, insurance plans may only provide coverage for on-label uses, which are uses approved by the FDA. As a brand-name drug, Trintellix may be more expensive than generic alternatives. Takeda Pharmaceuticals Inc.

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The Checkup by Singlecare

FEBRUARY 10, 2025

No generic version of Januvia is available in the United States, but this could change in 2026 when the main patent expires. The first patent, covering the dihydrogen phosphate salt of sitagliptin, expires on November 24, 2026. Polycystic ovary syndrome (PCOS) Januvia can also be prescribed off-label to treat PCOS.

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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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pharmaphorum

JULY 8, 2021

If approved, TSLP inhibitor tezepelumab could reach the market with a broader label than currently-used asthma antibodies, which are approved to treat patient with severe asthma characterised by high levels of eosinophils – a type of white blood cell.

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The FDA Law Blog

JULY 7, 2024

10] Performance specifications “include all claims made in the labeling for the device,” and “the intended performance of a device refers to the intended use for which the device is labeled or marketed.” [11] With respect to the UDI requirement, FDA regulations require them to be placed on the device “label.”

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pharmaphorum

APRIL 23, 2021

At the moment, IgAN is controlled using blood pressure medication to limit damage to the kidney, with immunosuppressants such as corticosteroids used off-label in some cases to suppress the autoimmune response. It is usually diagnosed after patients see blood in their urine and undergo a kidney biopsy.

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

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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

MAY 9, 2023

The 5th Panel of the Federal Court of the 1st Region (Tribunal Regional Federal da 1ª Região, TRF-1) upheld the existing expiry dates of two patents—one for semaglutide itself (2026), and the other for the delivery mechanism for the oral formulation of the drug, Rybelsus (2031). None of the three are currently publicly reimbursed.

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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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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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The FDA Law Blog

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026.

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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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DiversifyRx

JULY 11, 2024

The exemption will last until November 27, 2026, for those small dispensers who qualify. On June 12, 2024, the FDA released a notice stating that it is issuing exemptions from specific requirements of the DSCSA to small pharmacies to go into effect on 11/27/2024 to ensure patient access.

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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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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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The FDA Law Blog

FEBRUARY 13, 2025

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

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The FDA Law Blog

FEBRUARY 20, 2025

FDA had been scheduled to hold a webinar on the Stage 2 (May 2026) requirements related to the investigational device requirements for LDTs later this month. In fact, FDA has three guidances on its A list planned for this fiscal year that are specifically related to the LDT Rule or IVD (which FDA says includes LDTs) labeling (see here ).

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