pharmaphorum

AUGUST 2, 2023

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

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Labelling 98

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.

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Labelling 97

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.

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Labelling 92

Drug Store News

JULY 26, 2023

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

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Labelling 98

pharmaphorum

JUNE 28, 2023

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

Labelling 98

Labelling 98

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.

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Labelling Packaging FDA 98

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.”

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Labelling FDA Documentation Communication 72

Drug Topics

JULY 12, 2023

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

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Labelling 98

The FDA Law Blog

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.

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FDA Labelling Vaccines Communication 40

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.,

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FDA Labelling Packaging Grocery Stores 89

Pharmaceutical Technology

MARCH 22, 2023

What lies ahead for RFID and smart labelling Volpe says “the future is bright” for smart technologies that identify, monitor, and track medications through the supply chain. RFID is an important facet of smart labelling and its evolution, but not the only one.

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Labelling FDA Pharmaceutical Companies Pharmaceutical Companies 105

Roots Analysis

SEPTEMBER 13, 2023

The conjugation of biomolecules is also referred to as biomolecule labeling when the modification with conjugates lead to detection ( direct / indirect ) for bioimaging and immunoassays. The below figure highlights the different types of molecular conjugates and labels that can be conjugated with various molecules.

Labelling 40

Labelling 40

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

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Labelling FDA Communication 98

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.

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Labelling 98

Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age.

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Labelling FDA 98

Pharmaceutical Commerce

JULY 10, 2023

Platform is expected to streamline the label management process.

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Labelling 73

Fierce Pharma

MAY 15, 2023

UPDATED: After Supreme Court rejection, Teva mulls options in GSK 'skinny label' feud fkansteiner Mon, 05/15/2023 - 10:59

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Labelling 106

PharmExec

JULY 31, 2023

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

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Labelling 52

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.

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Labelling FDA Dosage Pharmaceutical Companies 52

pharmaphorum

JUNE 6, 2023

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

Labelling 97

Labelling 97

Pharmaceutical Technology

MARCH 16, 2023

Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care. One of the reasons why organisations, including pharma companies, do not enter this debate is because these drugs are used off label, says Horowicz.

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Labelling Pharmaceutical Companies Pharmaceutical Companies Patient Care 144

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.

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Labelling Pharmaceutical Companies Pharmaceutical Companies 98

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.

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Labelling 98

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.

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Labelling 105

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.

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Labelling Communication Packaging 52

PharmExec

AUGUST 23, 2023

Five industry experts discuss labeling challenges and trends in modernization.

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Labelling 52

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.

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Labelling FDA 123

The Checkup by Singlecare

JANUARY 26, 2023

If you’ve worked in a community pharmacy, you’ve likely had the same frustrating conversations about prescription labels over and over. Due to variability in health literacy, studies show that Americans’ level of understanding of prescription label instructions ranges from 53% to 89%.

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Labelling Community Pharmacies Dosage Packaging 52

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

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Labelling Packaging Dosage Documentation 52

Pharmaceutical Commerce

JULY 27, 2023

Purchase helps expands business’ label and packing services.

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Labelling 52

Fierce Pharma

JANUARY 4, 2023

Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord. Wed, 01/04/2023 - 11:35.

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Labelling 98

Pharmaceutical Technology

AUGUST 18, 2023

As restrictions on abortion drug mifepristone loom, doctors and patients are looking to off-label misoprostol as an alternative.

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Labelling 52

The FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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Labelling FDA Documentation 52

Fierce Pharma

DECEMBER 19, 2022

AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression. Mon, 12/19/2022 - 11:13.

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FDA Labelling 104

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

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FDA Labelling 52

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.

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Labelling 96

Fierce Pharma

MARCH 20, 2023

Novo Nordisk, Eli Lilly replenish Type 2 diabetes stars Ozempic, Mounjaro after off-label weight-loss boom fkansteiner Mon, 03/20/2023 - 10:09

Labelling 101

Labelling 101