Labelling - Pharmacy Technician Pulse

Gluten in Medications: Why Labeling Matters for Patients With Celiac Disease

Drug Topics

OCTOBER 3, 2023

Despite pleas from celiac disease advocates, the FDA still does not require drug manufacturers to note on the label whether a medication contains gluten.

Labelling

Labelling FDA

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

Labelling Insurance Coverage Insurance FDA

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

Can Patient-Centered Prescription Labels Increase Medication Adherence?

Drug Topics

FEBRUARY 9, 2023

Researchers evaluated how changes in USP labeling standards have affected adherence across multiple classes of drugs.

Labelling

Novo's obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion

Fierce Pharma

MARCH 8, 2024

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. |

Labelling

Labelling FDA

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 FDA Patient Care

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The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.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

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

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

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 FDA Communication

Sarepta details Elevidys launch progress while awaiting key FDA decision on label expansion

Fierce Pharma

FEBRUARY 29, 2024

Despite a restricted FDA label, Sarepta Therapeutics has seen early commercial success with its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. | The company is quickly moving through Elevidys' eligible patient population while awaiting the FDA's decision on a broader label.

Labelling

Labelling FDA

Sarepta enjoys early sales ramp for DMD gene therapy, maintains confidence in label expansion

Fierce Pharma

NOVEMBER 2, 2023

Even before a potential label expansion, the gene therapy Elevidys has raked in around $69 million since its launch. But Sarepta plans to seek a label expansion for the DMD gene therapy anyway. Earlier this week, the company said that a pivotal trial on the medicine failed to reach its primary endpoint.

Labelling

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

Clinicians Use SSRIs Off- Label in Many Conditions

Pharmacy Times

JANUARY 19, 2024

As the body of data has grown, clinicians’ propensity to use selective serotonin reuptake inhibitors off-label has increased

Labelling

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

Merck's Keytruda aims for updated stomach cancer label with positive data

Fierce Pharma

JUNE 16, 2023

Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study.

Labelling

Penicillin allergy labels can be safely removed for most patients, study suggests

Hospital Pharmacy Europe

MARCH 26, 2024

It is likely to be safe for penicillin allergy labels (PALs) to be removed for most patients, a study from the University of Birmingham has found. Some 97% of participants labelled with PALs were shown to have no allergy. However, a large body of evidence suggests that 90-95% of PALs are inaccurate.

Labelling

Labelling Hospitals

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

Labelling FDA

Southeastern Grocers debuts Know & Love private label line

Drug Store News

JULY 6, 2023

Know & Love will offer a wide range of affordable and clean-label products, including food, beverage and household items.

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

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 FDA

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

Dollar General expands Clover Valley private label line

Drug Store News

JULY 26, 2023

Dollar General is debuting more than 100 new items in its Clover Valley private label line in 2023.

Labelling

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

Skinny Label and Induced Infringement: The Saga Continues

The FDA Law Blog

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 FDA Documentation Communication

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

The FDA Law Blog

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

Labelling FDA

Bristol Myers banks on 25-plus label expansions to help weather IRA, Revlimid generics and more

Fierce Pharma

SEPTEMBER 15, 2023

With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of | With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from (..)

Labelling

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

Leqvio Gets Label Update For Earlier Use in Patients with Heart Disease

Drug Topics

JULY 12, 2023

Recent safety data also allowed four adverse events to be removed from the label.

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 Documentation FDA

FDA Issues Guidance on Biosimilar Labeling

BioPharm

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 Documentation FDA

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 Approves 2 Label Changes to Levothyroxine Sodium for the Treatment of Hypothyroidism

Pharmacy Times

DECEMBER 5, 2023

The approval marks levothyroxine sodium as the only FDA-granted LT4 therapy that does not have a labeled interaction with PPIs and can be taken 15 minutes prior to eating breakfast.

Labelling

Labelling FDA

On heels of FDA approval, trial results set up GSK's RSV vaccine for label expansion

Fierce Pharma

OCTOBER 25, 2023

Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy. The company has revealed that a study investigating Arexvy’s effectiveness in adults ages 50 to 59 has achieved its two primary objectives.

Labelling

Labelling Vaccines FDA

Lannett sells discontinued generics, inks private label deal for others

Drug Store News

OCTOBER 19, 2022

Lannett's deal call for another pharmaceutical company to purchase and distribute under a private label a limited number of certain other Lannett owned generic drug products.

Labelling

Labelling Pharmaceutical Companies Pharmaceutical Companies

12 Medications With Off-Label Uses

BuzzRx

JANUARY 27, 2023

The term “on-label use” of a drug may seem unfamiliar to most people. In short, this practice is referred to as “off-label” drug use. Surveys have shown that approximately 1 in 5 prescriptions in the US are for off-label use. In certain populations of patients, off-label drug use is even higher.

Labelling

Labelling FDA Dosage Pharmaceutical Companies

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 FDA

Delaware's Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

Fierce Pharma

SEPTEMBER 1, 2023

When it comes to heart failure medication, a labeling mix-up can have dire consequences. Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg mg dose, and vice versa.

Labelling

L’Oréal educates consumers on product environmental impact with labeling system

Drug Store News

DECEMBER 7, 2022

L’Oréal’s Product Impact Labeling gives items a ranking on a scale from A to E by considering 14 planetary impact factors.

Labelling

PLMA to hold annual Private Label Trade Show in Chicago in November

Drug Store News

JULY 6, 2023

Several beauty trends will be revealed at PLMA’s 2023 annual Private Label Trade Show, Nov. 12-14 in Chicago.

Labelling

Smart pharmaceutical and healthcare labels: Lets trace medicines from its origin

Roots Analysis

MARCH 8, 2023

In recent years, the use of smart labels allows the developer to convey a greater amount of information about the product to the consumers, without the need for additional packaging space. Further, smart labels play a critical role in the manufacturing of pharmaceuticals.

Labelling

Labelling Communication Packaging

FDA Approves Label Update for Semaglutide, Allowing Use as First-Line Option for Adults with Type 2 Diabetes

Pharmacy Times

JANUARY 16, 2023

Label update removes a previous limitation that stated the medication should not be used as initial therapy for treating patients with type 2 diabetes.

Labelling

Labelling FDA

FDA Approves Label Update for Biktarvy as Treatment of HIV in Pregnant Adults

Pharmacy Times

APRIL 26, 2024

The approval is based on data from Study 5310, evaluating the pharmacokinetics, safety, and efficacy of Biktarvy (Gilead Sciences Inc) in pregnant individuals.

Labelling

Labelling FDA

Gluten in Medications: Why Labeling Matters for Patients With Celiac Disease

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

Trending Sources

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

Can Patient-Centered Prescription Labels Increase Medication Adherence?

Novo's obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion

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

FDA revises biosimilar guidelines for clearer drug labelling

Pharmaceutical packaging companies and labelling machines

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

Defending Against Label-Based Lawsuits

FDA cracks down on off-label drug use messaging

Sarepta details Elevidys launch progress while awaiting key FDA decision on label expansion

Sarepta enjoys early sales ramp for DMD gene therapy, maintains confidence in label expansion

Samsung seeks 'interchangeable' label for Humira biosimilar

Clinicians Use SSRIs Off- Label in Many Conditions

CVS Health launches private label biosimilars unit

Merck's Keytruda aims for updated stomach cancer label with positive data

Penicillin allergy labels can be safely removed for most patients, study suggests

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

Southeastern Grocers debuts Know & Love private label line

Gilead’s Vemlidy expands label to treat paediatric chronic HBV

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

AbbVie, Genmab eye label expansion for Epkinly

Dollar General expands Clover Valley private label line

J&J seeks label expansion for Tremfya in ulcerative colitis

Skinny Label and Induced Infringement: The Saga Continues

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

Bristol Myers banks on 25-plus label expansions to help weather IRA, Revlimid generics and more

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

Leqvio Gets Label Update For Earlier Use in Patients with Heart Disease

FDA Issues Guidance on Biosimilar Labeling

FDA Issues Guidance on Biosimilar Labeling

ASCO: Enhertu data sets up tumour-agnostic label bid

FDA Approves 2 Label Changes to Levothyroxine Sodium for the Treatment of Hypothyroidism

On heels of FDA approval, trial results set up GSK's RSV vaccine for label expansion

Lannett sells discontinued generics, inks private label deal for others

12 Medications With Off-Label Uses

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

Delaware's Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

L’Oréal educates consumers on product environmental impact with labeling system

PLMA to hold annual Private Label Trade Show in Chicago in November

Smart pharmaceutical and healthcare labels: Lets trace medicines from its origin

FDA Approves Label Update for Semaglutide, Allowing Use as First-Line Option for Adults with Type 2 Diabetes

FDA Approves Label Update for Biktarvy as Treatment of HIV in Pregnant Adults

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