Labelling - Pharmacist Digest

STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label

STAT

MARCH 8, 2024

regulators approved a label expansion for Novo Nordisk’s obesity drug Wegovy to tout its benefits for the heart, a move that could boost demand and insurance coverage for the already highly popular treatment. Novo said it has also filed for a label expansion in Europe and a decision is expected this year.

Labelling

STAT+: ‘Skinny labels’ on generic medicines saved Medicare $15 billion over a recent six-year period

STAT

APRIL 30, 2024

The provision is known as skinny labeling, which refers to a move by a company that seeks regulatory approval to market a generic or biosimilar medicine for a specific use, but not for other patented uses for which the brand-name drug is prescribed. In short, this is a so-called carve-out.

Labelling

Labelling Generic Medicine Biosimilars

STAT+: FDA alters warning label for Carvykti CAR-T, although link to secondary cancers is unclear

STAT

DECEMBER 22, 2023

The Food and Drug Administration issued a change to the warning label for Legend Biotech and Janssen’s myeloma CAR-T, Carvykti or cilta-cel, adding that some secondary blood cancers have occurred following treatment for multiple myeloma with the cell therapy.

Labelling

Labelling Chemotherapy

AI in packaging and labelling processes

Express Pharma

MAY 15, 2024

Packaging and labelling, being an integral part of the products, are also transforming by adopting such contemporary technologies to remain at par with the industry standards across the globe. Artwork and Artwork Management System (AMS) are part of labelling which is an integral part of packaging.

Packaging

Packaging Labelling

STAT+: The FDA is testing new nutrition labels on the front of food packages

STAT

JUNE 20, 2023

Much of the Americas already has so-called front of package labels — small symbols printed on packaged foods that alert consumers when a food is high in certain unhealthy nutrients like sodium or saturated fat. Now, the Food and Drug Administration is embarking on a major study to test front of package labels here in the U.S.,

Packaging

Packaging Labelling Grocery Stores

STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access

STAT

MARCH 30, 2023

Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. solicitor general urged the U.S.

Labelling

Labelling Drug Pricing

Kellogg’s is going to war over Mexico’s nutrition label rules. A similar fight is coming to the U.S.

STAT

AUGUST 21, 2023

A 2019 policy requires companies that make unhealthy foods to include warning labels on the front of any boxes they sell in Mexico to educate consumers about things like excess sugar and fat. MEXICO CITY — Kellogg’s is waging a war here over Tigre Toño and Sam el Tucán.

Labelling

Labelling Packaging

National Academies calls for transforming use of racial and ethnic labels in genetics research

STAT

MARCH 14, 2023

Saying genetics researchers inconsistently and inappropriately use racial and ethnic labels that fail to capture the complex patterns of human genetic variation, the National Academies of Sciences, Engineering, and Medicine issued a report Tuesday calling for a transformation in how such descriptors are used.

Labelling

STAT+: U.S. Supreme Court declines bid by Teva to hear ‘skinny labeling’ case with implications for generic drug access

STAT

MAY 15, 2023

At issue is skinny labeling, which happens when a generic company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. And skinny labeling, which amounts to a carve-out, is one way that Congress attempted to foster more competition to benefit consumers.

Labelling

Labelling Drug Pricing

FIP argues for ‘approved format’ in e-labelling of medicines

The Pharmacist

APRIL 16, 2024

Various formats for the e-labelling of medicines may hinder patient access to information, a new report has warned.

Labelling

US FDA updates Sanofi’s Dupixent label for atopic dermatitis

Pharmaceutical Business Review

JANUARY 17, 2024

This label update is based on findings from the Phase III LIBERTY-AD-HAFT trial, the first to evaluate a biologic for this patient group. The post US FDA updates Sanofi’s Dupixent label for atopic dermatitis appeared first on Pharmaceutical Business review. It is not an immunosuppressant.

Labelling

PDURS explained: The FDA’s new framework for adding software to drug labels

pharmaphorum

MAY 20, 2024

In this fireside chat webinar, experts break down the FDA's new PDURS framework for adding software to drug labels. Learn how it impacts pharma and what you need to know. Join us on Tuesday 9th July @ 07:00am PDT / 10:00am EDT / 15:00pm BST / 16:00pm CEST.

Labelling

STAT+: ‘Skinny labels’ on biosimilar medicines saved Medicare $1.5 billion over a recent five-year period

STAT

NOVEMBER 28, 2022

The provision is known as skinny labeling , which refers to a move by a company that seeks regulatory approval to market a generic or biosimilar medicine for a specific use, but not for other patented uses for which the brand-name drug is prescribed. billion from 2015 to 2020 — or nearly 5% of the $30.2

Labelling

Labelling Biosimilars Drug Pricing

FDA revises biosimilar guidelines for clearer drug labelling

Pharmaceutical Technology

SEPTEMBER 18, 2023

The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.

Labelling

Labelling Biosimilars

Millions wrongly labelled allergic to penicillin, warns RPS

The Pharmacist

SEPTEMBER 29, 2023

The warning comes from the Royal Pharmaceutical Society (RPS) as it launches a new checklist for pharmacists to help inform conversations with patients about penicillin allergy. […] The post Millions wrongly labelled allergic to penicillin, warns RPS appeared first on The Pharmacist.

Labelling

Labelling Hospitals

Opinion: FDA’s plan to define “healthy” for food packaging: Better than the existing labeling anarchy, but do we really need it?

STAT

OCTOBER 7, 2022

” The proposed rules are a lot better than the labeling anarchy that currently exists. The FDA has announced the set of rules it proposes to enforce for manufacturers to claim that a food product is “healthy.” But here’s my bottom line: health claims are not about health. They are about selling food products.

Labelling

Labelling Packaging

Pharmaceutical packaging companies and labelling machines

Pharmaceutical Technology

MARCH 25, 2024

Download our extensive, free list of the leading pharmaceutical packaging companies and labelling machine manufacturers today.

Packaging

Packaging Labelling

Defending Against Label-Based Lawsuits

PharmExec

JANUARY 11, 2024

Best practices for defending against lawsuits based on pharmaceutical labeling, including avenues for early resolution of the case and, as necessary, strategies for developing the best evidence for defense.

Labelling

FDA cracks down on off-label drug use messaging

Pharmaceutical Technology

OCTOBER 24, 2023

The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.

Labelling

Labelling Communication

Samsung seeks 'interchangeable' label for Humira biosimilar

pharmaphorum

AUGUST 2, 2023

Samsung seeks 'interchangeable' label for Humira biosimilar Phil.Taylor Wed, 02/08/2023 - 10:37 Bookmark this

Labelling

Labelling Biosimilars

Angelini gets grant for method for labelling reels using robot and application roller

Pharmaceutical Technology

MARCH 29, 2024

Revolutionize your labeling process with Angelini Spa's patented method using a robot and label printer to efficiently attach printed labels to reels. Patent Publication Number: US11884443B2.

Labelling

Labetalol batch recalled due to wrong dosage labelling

The Pharmacist

JULY 10, 2023

A batch of Labetalol 200mg tablets has been recalled as they are incorrectly labelled as 100mg tablets on the foil blister packaging. Pharmacists have been instructed to immediately stop […] The post Labetalol batch recalled due to wrong dosage labelling appeared first on The Pharmacist.

Dosage

Dosage Labelling Packaging

CVS Health launches private label biosimilars unit

pharmaphorum

AUGUST 25, 2023

CVS Health launches private label biosimilars unit Phil.Taylor Fri, 25/08/2023 - 08:07 Bookmark this

Labelling

Labelling Biosimilars

AZ first to AKT finish line, but FDA clears narrow label

pharmaphorum

NOVEMBER 17, 2023

AZ first to AKT finish line, but FDA clears narrow label Phil.Taylor Fri, 17/11/2023 - 09:46 Bookmark this

Labelling

Off-label Use

RX Note

JULY 29, 2023

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

Labelling

Labelling Dosage Immunity Immunization

AbbVie, Genmab eye label expansion for Epkinly

pharmaphorum

JUNE 28, 2023

AbbVie, Genmab eye label expansion for Epkinly Phil.Taylor Wed, 28/06/2023 - 13:04 Bookmark this

Labelling

Gilead’s Vemlidy expands label to treat paediatric chronic HBV

Pharmaceutical Technology

MARCH 29, 2024

Its label was expanded in 2022 for use in patients 12 years and older. Vemlidy was first approved to treat adults with HBV in 2016.

Labelling

Labelling Drug Development

Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog: Biosimilars

MAY 11, 2023

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

Labelling

Labelling Documentation Communication

J&J seeks label expansion for Tremfya in ulcerative colitis

Pharmaceutical Technology

MARCH 12, 2024

Johnson & Johnson’s Tremfya is approved for plaque psoriasis and active psoriatic arthritis, with a label for ulcerative colitis now on the horizon.

Labelling

Sartorius – Octet Label free detection system

Express Pharma

JULY 26, 2023

Real-Time, Label-Free, Stress Free Protein Analysis. The Sartorius Octet® systems, built using label-free Bio-Layer Interferometry (BLI) optical technology, offer a fast, robust and fluidics-free approach to protein analysis. Download the brochure and learn more about the Octet® R Series Systems.

Labelling

ASCO: Enhertu data sets up tumour-agnostic label bid

pharmaphorum

JUNE 6, 2023

ASCO: Enhertu data sets up tumour-agnostic label bid Phil.Taylor Tue, 06/06/2023 - 08:26 Bookmark this

Labelling

FDA Issues Guidance on Biosimilar Labeling

Pharmaceutical Commerce

SEPTEMBER 19, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Labelling

Labelling Biosimilars Documentation

FDA Issues Guidance on Biosimilar Labeling

PharmaTech

SEPTEMBER 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Labelling

Labelling Biosimilars Documentation

Establishing a Framework for Reliable Pharma Labeling

PharmaTech

DECEMBER 2, 2023

By taking a strategic and evidence-based approach, companies can leverage the insights gained from stability studies to establish robust labeling.

Labelling

Traditional Meat Industry’s Beef With Alternative Protein Continues with the FAIR on Labels Act

FDA Law Blog: Biosimilars

MARCH 5, 2024

Many individual states have pursued some type of legislation to restrict the use of traditional meat terminology for the labeling of APPs. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims.

Labelling

FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

Labelling

FDA rejects label expansion for Dynavax’s hepatitis B vaccine

Pharmaceutical Technology

MAY 15, 2024

The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.

Vaccines

Vaccines Labelling

IQVIA Unveils New Labeling Solution

Pharmaceutical Commerce

JULY 10, 2023

Platform is expected to streamline the label management process.

Labelling

FDA approves label update of Novartis’ Leqvio to treat high LDL-C

Pharmaceutical Business Review

JULY 11, 2023

The label update reinforces the safety and effectiveness data of Leqvio generated by the VictORION clinical trial programme, claimed the company. Among the other updates to the label include the removal of the Limitations of Use statement. Leqvio was initially approved by the FDA in December 2021.

Labelling

Current Innovations in Global Pharma Labeling

PharmExec

JULY 31, 2023

Insights into current practice of global pharma labeling, including shortcomings and potential improvements.

Labelling

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

Labelling

Labelling Vaccines Communication

Tracking bird flu virus changes in cows is stymied by missing data, scientists say

STAT

MAY 2, 2024

All are simply labeled with “USA” and “2024.” Like a large tranche of sequences that the USDA uploaded to a public database on April 21, this week’s data dump did not include information about where and when the sequenced samples were obtained from cows or other sequenced animals.

Labelling

FDA clears Wegovy’s label to include heart health benefits

pharmaphorum

MARCH 11, 2024

Novo Nordisk’s Wegovy has been given a first-in-class approval by the FDA to reduce the risk of serious cardiovascular conditions in people who are overweight or obese

Labelling

Panel Discussion on AI and automation: Revolutionising pharma packaging and labelling | PPL Conclave 2024

Express Pharma

MARCH 20, 2024

Material Sourcing (Strategic & Plant), Global Supply Chain Management, Dr Reddy’s Laboratories (Moderator) + Chandi Prasad Ravipati, Head-Packaging Development, Aurobindo Pharma + Santanu Chowdhury, Sr GM – Packaging Development, Sun Pharmaceutical Industries + Prabir Das, Pharma Expert + Dr Sajeev Chandran, VP – Pharma R&D, (..)

Packaging

Packaging Labelling

STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label

STAT+: ‘Skinny labels’ on generic medicines saved Medicare $15 billion over a recent six-year period

Trending Sources

STAT+: FDA alters warning label for Carvykti CAR-T, although link to secondary cancers is unclear

AI in packaging and labelling processes

STAT+: The FDA is testing new nutrition labels on the front of food packages

STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access

Kellogg’s is going to war over Mexico’s nutrition label rules. A similar fight is coming to the U.S.

National Academies calls for transforming use of racial and ethnic labels in genetics research

STAT+: U.S. Supreme Court declines bid by Teva to hear ‘skinny labeling’ case with implications for generic drug access

FIP argues for ‘approved format’ in e-labelling of medicines

US FDA updates Sanofi’s Dupixent label for atopic dermatitis

PDURS explained: The FDA’s new framework for adding software to drug labels

STAT+: ‘Skinny labels’ on biosimilar medicines saved Medicare $1.5 billion over a recent five-year period

FDA revises biosimilar guidelines for clearer drug labelling

Millions wrongly labelled allergic to penicillin, warns RPS

Opinion: FDA’s plan to define “healthy” for food packaging: Better than the existing labeling anarchy, but do we really need it?

Pharmaceutical packaging companies and labelling machines

Defending Against Label-Based Lawsuits

FDA cracks down on off-label drug use messaging

Samsung seeks 'interchangeable' label for Humira biosimilar

Angelini gets grant for method for labelling reels using robot and application roller

Labetalol batch recalled due to wrong dosage labelling

CVS Health launches private label biosimilars unit

AZ first to AKT finish line, but FDA clears narrow label

Off-label Use

AbbVie, Genmab eye label expansion for Epkinly

Gilead’s Vemlidy expands label to treat paediatric chronic HBV

Skinny Label and Induced Infringement: The Saga Continues

J&J seeks label expansion for Tremfya in ulcerative colitis

Sartorius – Octet Label free detection system

ASCO: Enhertu data sets up tumour-agnostic label bid

FDA Issues Guidance on Biosimilar Labeling

FDA Issues Guidance on Biosimilar Labeling

Establishing a Framework for Reliable Pharma Labeling

Traditional Meat Industry’s Beef With Alternative Protein Continues with the FAIR on Labels Act

FDA Releases Draft Labeling Guidance for Biosimilar Products

FDA rejects label expansion for Dynavax’s hepatitis B vaccine

IQVIA Unveils New Labeling Solution

FDA approves label update of Novartis’ Leqvio to treat high LDL-C

Current Innovations in Global Pharma Labeling

FDA-Approved Labeling: Is Enough Enough?

Tracking bird flu virus changes in cows is stymied by missing data, scientists say

FDA clears Wegovy’s label to include heart health benefits

Panel Discussion on AI and automation: Revolutionising pharma packaging and labelling | PPL Conclave 2024

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