Labelling - Pharmacist Digest

STAT+: Lawmakers want FTC to probe big PBMs over private-label biosimilar deals

STAT

OCTOBER 2, 2024

In reality, the arrangements actually resemble private-label distribution, but the lawmakers worry these agreements could cause consumers to pay higher prices. These new business units have since used these deals as springboards to market the medications to health plans.

Labelling

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

Off-label treatment for alcohol use disorder is linked to slower liver decline, study suggests

STAT

MAY 22, 2024

But a different medication, one frequently used off-label for the condition, could provide greater benefit to patients with alcohol-associated liver disease, a new study suggests. WASHINGTON — There are three FDA-approved drugs for treating alcohol use disorder.

Labelling

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Skinny-Label Lives to See Another Day

FDA Law Blog: Biosimilars

OCTOBER 16, 2024

Koblitz — Further talks of the Skinny Label’s demise may be premature, as demonstrated by a new decision from the District Court for the District of Columbia upholding FDA’s interpretation of the “same labeling” provisions of the Hatch-Waxman Amendments. Teva and Amarin v. Citing to “[b]inding Circuit law” in Bristol-Myers Squibb v.

Labelling

Labelling Hospitals

STAT+: New Wegovy analysis could boost Novo Nordisk’s bid to expand drug’s label in heart failure

STAT

AUGUST 30, 2024

Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment. of those who received placebo.

Labelling

Labelling Hospitals

STAT+: Pharmalittle: We’re reading about a Merck drug-label controversy, Astellas pulling an application, and more

STAT

OCTOBER 28, 2024

The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population. As the original brand-name manufacturer, however, Merck continues to have legal responsibility for the labeling, which means that all available versions lack the details.

Labelling

Labelling Chemotherapy

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

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+: 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

AYUSH, PHD Chamber of Commerce and Industry organise conference on labelling and packaging provisions for ASU products

Express Pharma

AUGUST 9, 2024

AYUSH Committee, PHD Chamber of Commerce and Industry organised a Conference on Labelling and Packaging Provisions for ASU products recently at PHD House, New Delhi. He further urged bigger Industry players to kindly create awareness about the labelling and packaging procedures.

Packaging

Packaging Labelling Communication

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

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

Reducing Medication Errors Through Product Label Changes

PharmExec

OCTOBER 9, 2024

Laura Johnson, senior director, sales, life sciences, Loftware, discusses innovations in label design that could lead to improved patient outcomes and less medical errors.

Labelling

Ensuring That Product Labels Are Easily Understood

PharmExec

OCTOBER 7, 2024

Laura Johnson, senior director, sales, life sciences, Loftware, discusses ways to ensure that product labels are easily understood universally.

Labelling

Sarepta bags key expansion to DMD gene therapy label in US

pharmaphorum

JUNE 20, 2024

Sarepta gets best-case approval from the FDA for an expansion to the label for its Duchenne muscular dystrophy gene therapy Elevidys.

Labelling

Challenges of Unclear Product Labeling on Patient Outcomes

PharmExec

OCTOBER 8, 2024

Laura Johnson, senior director, sales, life sciences, Loftware, discusses scenarios where unclear labeling led to challenges for patient outcomes.

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

What’s in a drink? U.S. regulators consider new alcohol label, but health advocates want even more

STAT

AUGUST 12, 2024

If you twirl a bottle of alcohol and squint, you might see a text box with a warning. Usually in black and white, with letters two to three millimeters high, it reads: GOVERNMENT WARNING: (1) According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects. (2)

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

The Challenges of Prescription Labeling for the Pharmaceutical Industry

PharmExec

OCTOBER 2, 2024

Laura Johnson, senior director, sales, life sciences, Loftware, discusses issues faced by the pharmaceutical industry when it comes to proper drug labeling.

Labelling

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

Latin labelling on cosmetics is a risk to food allergy sufferers, says MP

The Guardian - Pharmaceutical Industry

OCTOBER 19, 2024

Becky Gittins calls for cosmetic firms to list ingredients in English, saying current labelling is ‘absolutely bonkers’ Cosmetic companies need to stop forcing people with food allergies to learn Latin to safeguard their health and display warnings written in plain English, according to an MP with a history of severe allergic reactions who is demanding (..)

Labelling

FDA widens label for BMS’ cancer drug Augtyro

pharmaphorum

JUNE 14, 2024

FDA widens label for BMS’ cancer drug Augtyro Phil.Taylor Fri, 14/06/2024 - 08:17 Bookmark this

Labelling

EMA CHMP recommends label update to Novo Nordisk’s Wegovy

Pharmaceutical Technology

SEPTEMBER 20, 2024

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended an update to Novo Nordisk’s Wegovy label.

Labelling

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

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

Drugs prescribed off-label may do more harm than good

World Pharma News

SEPTEMBER 9, 2024

A new study from King's College London shows that off-label prescriptions of a common antidepressant doesn't help breathlessness in patients with respiratory disease - and may cause side effects.

Labelling

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

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

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

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

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

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

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 Immunization Immunity

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

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

Thinking outside of the box: Digitising pharmacy dispensing labels

Pharmaceutical Technology

JUNE 12, 2024

Written Medicine is a digital solution that provides bilingual dispensing labels, described in a presentation at the NHS ConfedExpo conference in Manchester.

Labelling

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

STAT+: Drug may make chemotherapies less effective in cancer patients with obesity — but many doctors are in the dark

STAT

OCTOBER 28, 2024

The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population. As the original brand-name manufacturer, however, Merck continues to have legal responsibility for the labeling, which means that all available versions lack the details.

Chemotherapy

Chemotherapy Labelling

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

STAT+: Lawmakers want FTC to probe big PBMs over private-label biosimilar deals

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

Webinars

Trending Sources

Off-label treatment for alcohol use disorder is linked to slower liver decline, study suggests

Webinars

Skinny-Label Lives to See Another Day

STAT+: New Wegovy analysis could boost Novo Nordisk’s bid to expand drug’s label in heart failure

STAT+: Pharmalittle: We’re reading about a Merck drug-label controversy, Astellas pulling an application, and more

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

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

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.

AYUSH, PHD Chamber of Commerce and Industry organise conference on labelling and packaging provisions for ASU products

AI in packaging and labelling processes

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

Reducing Medication Errors Through Product Label Changes

Ensuring That Product Labels Are Easily Understood

Sarepta bags key expansion to DMD gene therapy label in US

Challenges of Unclear Product Labeling on Patient Outcomes

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

What’s in a drink? U.S. regulators consider new alcohol label, but health advocates want even more

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

The Challenges of Prescription Labeling for the Pharmaceutical Industry

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

US FDA updates Sanofi’s Dupixent label for atopic dermatitis

Latin labelling on cosmetics is a risk to food allergy sufferers, says MP

FDA widens label for BMS’ cancer drug Augtyro

EMA CHMP recommends label update to Novo Nordisk’s Wegovy

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

FDA revises biosimilar guidelines for clearer drug labelling

Drugs prescribed off-label may do more harm than good

Millions wrongly labelled allergic to penicillin, warns RPS

Labetalol batch recalled due to wrong dosage labelling

Samsung seeks 'interchangeable' label for Humira biosimilar

FDA cracks down on off-label drug use messaging

CVS Health launches private label biosimilars unit

Defending Against Label-Based Lawsuits

Off-label Use

AbbVie, Genmab eye label expansion for Epkinly

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

Thinking outside of the box: Digitising pharmacy dispensing labels

Skinny Label and Induced Infringement: The Saga Continues

STAT+: Drug may make chemotherapies less effective in cancer patients with obesity — but many doctors are in the dark

Pharmaceutical packaging companies and labelling machines

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