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. 

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Labelling Chemotherapy 312

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.

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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.

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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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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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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 246

Drug Channels

JANUARY 22, 2025

As youll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace. For 2025, the Big Three PBMs shifted national formularies to favor their private-label biosimilars over Humira and its many biosimilar competitors.

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Biosimilars Labelling 98

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 246

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.

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RX Note

DECEMBER 25, 2024

Labelling Requirements A ll dispensed medicine should be labelled according to the requirement stated by the law. NOTE: It is advisable for labels to be printed. Consequently, a patient-centred label strategy is introduced to promote appropriate medication use and adherence. Suggestions include Use larger font sizes (e.g.

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Labelling Dosage Packaging Communication 52

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

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Labelling Biosimilars Drug Pricing 255

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)

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Labelling 362

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.

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Labelling Packaging 246

STAT

JANUARY 15, 2025

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.    Sign up here. Yesterday, I read a dispassionate explanation in the New York Times of how to become a better swimmer. I’m already a proficient swimmer, so I knew all of the lessons. Keep your head looking down , guys!)

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Labelling 283

STAT

JUNE 17, 2024

United States Surgeon General Vivek Murthy wants to add a warning label on social media.

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Labelling 348

pharmaphorum

DECEMBER 3, 2024

The MHRA has reminded pharma companies that from 1st January all medicines sold in the UK will have to comply with new labelling requirements

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Labelling 124

STAT

SEPTEMBER 4, 2024

Oddly, he thought, a different number labeled “if not African American” read even lower: 31. The words sat next to a number estimating how badly Cannon’s kidneys were failing. And they were definitely failing. His number read 37, less than half of what is considered normal for adults. Read the rest…

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Labelling 343

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.

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Labelling 364

STAT

JUNE 18, 2024

It’s a new labeling system for the NWS, which launched the experimental rating at the end of April with the Centers for Disease Control and Prevention in response to the growing danger of extreme heat.

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Labelling 361

STAT

SEPTEMBER 18, 2024

But analysts and Organon see the real potential in Dermavant’s standing application with the Food and Drug Administration to expand the drug’s label to include atopic dermatitis, another chronic skin condition that affects around 25 million children and adults in the U.S. 

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Labelling 297

STAT

AUGUST 2, 2024

Researchers from the University of San Diego and the University of Pécs in Hungary found that semaglutide ordered from these illegal sites contained significantly more of the drug than labeled. One sample also contained signs of potential bacterial contamination during manufacturing. Read the rest…

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Online Pharmacies Labelling Compounding Diabetes 360

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.

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Labelling 119

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.

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Labelling 111

STAT

NOVEMBER 7, 2023

1 letter, the AGs noted that it had been a year since the FDA convened a public meeting of experts , who called for clearer labeling and more rigorous testing of the devices, and that no action had been taken. Read the rest…

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Labelling 363

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.

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Packaging Labelling Communication 105

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.

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Labelling Hospitals 115

STAT

JULY 2, 2024

With no FDA-approved treatment effective for Savannah’s condition, the family tried nearly 30 off-label medications in their search for relief. None worked. Read the rest…

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Labelling 339

STAT

JUNE 24, 2024

This outcome included up to six months of data from an open-label extension that followed the blinded period of the trial. Additionally, vutrisiran cut the risk of all-cause death, a secondary endpoint, by 36% in the overall population and 35% in the monotherapy group. Continue to STAT+ to read the full story…

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Labelling 362

STAT

NOVEMBER 21, 2023

Nearly 25 million Americans — from Hmong to Laotians, and Koreans to Indonesians — have been given the same label by the U.S. Yet in medical research and public health in the United States, people with Asian ancestry are almost always grouped into a single racial category.

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Labelling 364

STAT

MAY 16, 2023

Oh, what a beautiful morning! Pardon the cliché, but crystal clear blue skies and deliciously cool breezes are encompassing the Pharmalot campus today. So we will celebrate our good fortune with a delightful cup of stimulation. Our choice today is toasted hazelnut. As always, you are invited to join us, or grab a water bottle if you prefer.

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Labelling Drug Development 243

STAT

MARCH 14, 2024

Wegovy’s new label indicates that the drug can be used to reduce the risk of major heart complications for people who are overweight or obese and have existing heart disease, Novo said in a statement Friday.

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Labelling 363

STAT

OCTOBER 16, 2024

  In a perspective paper published with the National Institutes of Health this week, the agency labeled the effort to help Americans quit smoking a top priority and said it was willing to consider broader endpoints in clinical trials of smoking cessation products. 

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Labelling 297

STAT

DECEMBER 11, 2023

Not only is Lyfgenia significantly more expensive, but its prescribing label carries a “black box” safety warning, which requires patients undergo regular blood monitoring for cancer risk. Bluebird priced Lyfgenia at $3.1 Casgevy has no similar monitoring requirement. Continue to STAT+ to read the full story…

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Labelling 355

STAT

APRIL 18, 2024

And Charles River was also accused of falsely labeling the monkeys in sales made to its research clients. The company, one of the largest clinical research organizations, was accused of failing to disclose purchases of thousands of non-human primates that should not have been imported into the U.S.

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Labelling Pharmaceutical Companies Pharmaceutical Companies Drug Development 351

STAT

SEPTEMBER 29, 2022

” The proposed label rule aims, in part, to address a question as old as medicine: What does it mean for a food to be healthy? It would update the “healthy” label guidelines from 1994 to match up-to-date nutrition research — a notoriously messy and heavily debated field.

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Labelling 255

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.

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Labelling 103

STAT

OCTOBER 28, 2024

Today we take note of the antagonism between gene-editing players Prime Medicine and Tessera Therapeutics, consider the issue of whether the label should be updated on a Merck drug, and more.   Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox. 

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Labelling Drug Pricing Drug Development 263