Deadline looms for post-Brexit label changes for UK meds
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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FDA Adds Delayed Gastric Emptying as Adverse Event on Semaglutide Label
Pharmacy Times
NOVEMBER 14, 2024
The label includes postmarking reports showing rare instances of pulmonary aspiration for patients undergoing procedures that require general anesthesia or deep sedation.
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Skinny-Label Lives to See Another Day
The FDA Law Blog
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.
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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.
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HLTH24: Here’s a first look at a draft 'nutrition label' for health AI
Fierce Healthcare
OCTOBER 20, 2024
The Coalition for Health AI released a draft of their AI model card, or “nutrition label” for AI, filled out with information from AI imaging company Aidoc. LAS VEGAS—The Coalition for Health AI unveiled the first applied model card, completed by AI imaging company Aidoc. |
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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.
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Off-Label Semaglutide Linked to Deaths, Hospitalizations Calling for Compounding Regulation
Pharmacy Times
NOVEMBER 8, 2024
Off-label semaglutide has been linked to serious adverse effects, calling for increased regulation around compounding.
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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.
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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.
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Sarepta scores 'transformational' FDA label expansion for Duchenne gene therapy Elevidys
Fierce Pharma
JUNE 20, 2024
The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. |
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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.
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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.
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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.
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The Influence of PD-1 Inhibitor Label Restrictions on Future Studies
PharmExec
NOVEMBER 20, 2024
Ron Lanton, Partner, Lanton Law, ways that the recent FDA PD-1 inhibitor label restrictions could influence future drug development strategies.
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Potential Legal Action Against PD-1 Inhibitor Label Restrictions for Gastric Cancers
PharmExec
NOVEMBER 19, 2024
Ron Lanton, Partner, Lanton Law, discusses potential challenges that will come as a result of the FDA’s recent move to tighten label restrictions on PD-1 inhibitors for gastric cancers.
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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.
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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.
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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.
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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. |
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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.
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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.
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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
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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.
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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.
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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.
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AHA 2024: Lerodalciep provides promising results in open-label extension trial, LIBERATE-OLE
Pharmaceutical Technology
NOVEMBER 18, 2024
At AHA 2024, clinical trial results were presented from the ongoing open-label extension trial, LIBERATE-OLE, involving lerodalciep.
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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.
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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.
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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.
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Incyte looks to widen Monjuvi's net with label expansion bid after phase 3 lymphoma win
Fierce Pharma
AUGUST 16, 2024
Months after securing the full rights to anti-CD19 antibody Monjuvi (tafasitamab) from partner MorphoSys, Incyte has the data to potentially back a label expansion into lymphoma. | The company looks to file its drug for a follicular lymphoma indication as part of a later-line triple combo therapy by the end of the year.
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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.
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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
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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.
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8 common off-label uses of SSRIs
The Checkup by Singlecare
JUNE 20, 2024
This is called off-label prescribing , and SSRIs rank among the top use cases for off-label use. Pharmacists, in particular, should be familiar with off-label uses of SSRIs, as you may come across off-label prescriptions in everyday practice. These are some of the common off-label uses for SSRIs.
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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
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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.
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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 (..)
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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.,
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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.
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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
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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.
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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
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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.
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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.”
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