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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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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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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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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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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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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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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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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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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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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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 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+: 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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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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FDA Approves Updated Label for Altuviiio for Effective Bleed Protection in Children Younger than 12 Years
Drug Topics
MAY 13, 2024
Altuviiio was first granted approval by the FDA in February 2023.
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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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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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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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FDA blesses atopic dermatitis label expansions for Organon's Vtama, Galderma's Nemluvio
Fierce Pharma
DECEMBER 16, 2024
Vtamas label expansion came just three days after the FDA gave a thumbs up to Galdermas Nemluvio, which was previously endorsed by the FDA for prurigo nodularis. . | The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD).
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Pharmacy Education Must Keep Pace With Changing Health Care Landscape | ACCP 2024
Drug Topics
OCTOBER 16, 2024
Posters presented at ACCP 2024 revealed gaps in pharmacy students’ understanding of off-label drug applications and identified strengths and weaknesses among pharmacy graduates.
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FDA Approves Updated Label for Bempedoic Acid, Ezetimibe Tablets
Pharmacy Times
DECEMBER 14, 2023
The update also removed the maximally tolerated qualifier for statin use and the statement that said morbidity and mortality was not yet determined.
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FDA Expands Label for Bempedoic Acid to Reduce Cardiovascular Risk, With or Without Statins
Pharmacy Times
MARCH 22, 2024
Bempedoic acid (Nexletol; Esperion) and bempedoic acid and ezetimibe (Nexlizet; Esperion) are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
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Trio of Indian drugmakers issue recalls tied to impurity, labeling issues
Fierce Pharma
DECEMBER 18, 2024
Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling. Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling.
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Floreo nabs FDA breakthrough label for its VR software
Fierce Healthcare
DECEMBER 11, 2023
Floreo, maker of virtaul reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation. | Floreo says it seeks full market authorization to further recognize its effectiveness and to open up reimbursement pathways for its tech to reach more families.
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15 Antibiotic Myths To Beware
IDStewardship
OCTOBER 27, 2022
Myth 9: Penicillin allergy labels are not a big deal. Approximately 10% of the US adult population has a penicillin allergy label and only about 10% of those labels represent true allergies. Inappropriate penicillin allergy labels are a scourge on our society and force us to use second- or third-line treatments.
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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)
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FDA clears Wegovy’s label to include heart health benefits
pharmaphorum
MARCH 11, 2024
Novo Nordisk’s Wegovy has been given a first-in-class approval by the FDA to reduce the risk of serious cardiovascular conditions in people who are overweight or obese
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SpartanNash unveils Finest Reserve premium private label brand
Drug Store News
FEBRUARY 23, 2024
The collection is currently a curated offering of artisan-crafted frozen pizzas, upscale pastas, sauces, dressings, premium and more.
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How Do White Label Products Work for Pharmacies?
PioneerRx
SEPTEMBER 17, 2024
As you well know, there are countless ways to make more money for your pharmacy. From leveraging your pharmacy technology to expanding your clinical services.
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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.
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Lantidra Cell Therapy for Type 1 Diabetes Approved by FDA
Drug Topics
JUNE 29, 2023
The approval was based on safety and efficacy data from 30 participants in 2 open-label, single-arm studies that received 1 to 3 infusions of donislecel.
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J&J bids to add smouldering myeloma to Darzalex label
pharmaphorum
NOVEMBER 10, 2024
Johnson & Johnson looks on course to make Darzalex the first approved drug therapy for smouldering multiple myeloma, after a phase 3 win
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JPM24: Riding label expansions and launches, AZ plots course toward 'industry-leading growth' by 2030
Fierce Pharma
JANUARY 10, 2024
With a late-stage pipeline spanning more than 120 clinical trials and a firm grasp of five major disease areas, AstraZeneca appears confident heading into 2024. | In AZ's push to reach industry-leading growth by 2030, confidence is key, chief financial officer Aradhana Sarin said at the J.P. Morgan Healthcare Conference.
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Online Pharmacies Are Illegally Selling GLP-1s Without Prescriptions
Drug Topics
AUGUST 5, 2024
A study found that test products purchased from illegal online pharmacy operations had lower purity levels and significantly more semaglutide content than what was advertised on the label.
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Calliditas wins over FDA for full approval, broader label on kidney disease drug Tarpeyo
Fierce Pharma
DECEMBER 20, 2023
Two years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics has
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FDA expands Novartis’ Kisqali label to include early breast cancer patients
Pharmaceutical Technology
SEPTEMBER 18, 2024
Kisqali generated $2bn in sales last year, with broader approvals forecasting sales of over $8bn by 2030, per GlobalData analysis.
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Eli Lilly rolls out direct patient access to weight loss star Zepbound—at a deep discount
Fierce Pharma
AUGUST 27, 2024
Eli Lilly has come up with a new way of supplying its popular weight-loss drug Zepbound that the company hopes could expand access while addressing other issues such as high prices and off-label co | Eli Lilly is offering its popular weight-loss drug Zepbound directly to consumers at a discount through its own online pharmacy.
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In label expansion bid, AbbVie and Roche's Venclexta falls short in multiple myeloma subset
Fierce Pharma
SEPTEMBER 29, 2023
After establishing Venclexta as a treatment for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML), AbbVie and Roche were hoping to demonstrate the med's promise in a subset of mul | Despite the trial missing its primary endpoint of progression-free survival, the companies will soon discuss the "potential favorable trends" (..)
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FDA Approves Updated Label for Altuviiio to include Full Data on Pediatric Patients With Hemophilia A
Pharmacy Times
MAY 13, 2024
Antihemophilic factor (recombinant) Fc-VWF-XTEN fusion protein-ehtl was initally approved in February 2023 for adults and children with hemophilia A for prophylaxis and on-demand treatment to control bleeding.
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Noom to offer compounded GLP-1 drug to rival pricey branded weight loss meds
Fierce Healthcare
SEPTEMBER 17, 2024
Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers. Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers.
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Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder
Fierce Pharma
APRIL 16, 2024
Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.
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AbbVie touts Rinvoq win in giant cell arteritis, potentially teeing up another label expansion
Fierce Pharma
APRIL 18, 2024
Less than a year ago, AbbVie's star immunology drug Rinvoq picked up its seventh FDA approval< | AbbVie's Rinvoq has racked up seven FDA approvals in recent years, and another expansion into giant cell arteritis could be in the cards after a positive trial.
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