Putting Patients First Blog

JULY 2, 2024

1 And we appreciated CMS’ thorough responses to comments for IPAY 2026 and hope the Agency will replicate this for this comment opportunity. These elements were previously highlighted in our comments in response to the IPAY 2026 guidance, and we continue to stress their importance for the 2027 draft guidance.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

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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Labelling Drug Pricing Compounding Payment Processing 105

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. link] duals-rfi/.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

Pharmaceutical Technology

JULY 26, 2022

There are two branded miglustat therapies available across the 3MM, with the US market having Johnson and Johnson’s (J&J, US) Zavesca and also generic miglustat available, but neither of these are approved for the treatment of NPC, so physicians prescribe this therapy off-label.

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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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Vaccines Labelling 64

FDA Law Blog: Biosimilars

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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Labelling Packaging Documentation 59

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.

Labelling 64

Labelling 64

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.

Labelling 52

Labelling 52

FDA Law Blog: Biosimilars

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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Labelling Communication Documentation 64

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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Labelling Immunity Immunization 52

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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Labelling Immunity Immunization Vaccines 52

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

Packaging 52

Packaging Labelling 52

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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Diabetes Labelling 59

Big Molecule Watch

DECEMBER 28, 2023

Coya later reported its 48-week clinical data for a proof-of-concept open-label study in 4 patients with amyotrophic lateral sclerosis (ALS) demonstrating that treatment with COYA 302 appeared to ameliorate disease progression. Dr. Reddy’s will have exclusive rights to the same in areas outside of these territories.

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Biosimilars Labelling 69

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.

Labelling 52

Labelling Hospitals 52

Big Molecule Watch

JANUARY 10, 2025

These new prices will take effect starting January 1, 2026. pharmacies in 2023, and with the PBMs operating in a system from the drug private labeler all the way down to the pharmacy and health insurer. The reductions in price ranged from 38 to 79 percent of the 2023 listed prices for the drugs.

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Biosimilars Drug Pricing Labelling Communication 45

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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Biosimilars Labelling Diabetes Compounding 52

FDA Law Blog: Biosimilars

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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Labelling Communication 64

Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

Big Molecule Watch

AUGUST 25, 2023

The MFP will then be published on September 1, 2024, and will take effect on January 1, 2026. The MFPs for this first round of drugs will take effect starting January 1, 2026. Negotiations will take place over the course of the following year, ending on August 1, 2024. For the first year, CMS will select 10 drugs.

Drug Pricing 40

Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

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.

Dosage 56

Dosage Labelling Immunity Immunization 56

Safe Biologics

MAY 10, 2024

1 and go into effect in 2026. Now it’s time to go further and give Medicare the power to negotiate lower prices for 500 drugs over the next decade. CMS is currently working to set prices for 10 drugs, with the final prices set to be announced by Sept.

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Biosimilars Drug Pricing Documentation Labelling 130

Safe Biologics

APRIL 10, 2023

Significantly for the INN group, a 2020 WHO report identified inconsistent nomenclature as a remaining challenge as it is clear that naming and labelling are both very important for pharmacovigilance and prescribing.

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Biosimilars Drug Pricing Diabetes Labelling 130

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).

Labelling 52

Labelling Communication Vaccines 52

FDA Law Blog: Biosimilars

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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Documentation Labelling Method Validation Communication 71

FDA Law Blog: Biosimilars

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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Labelling Communication 102