epicur

FEBRUARY 23, 2023

Accurate Ingredient Labeling Accurate labeling also applies more in 503A pharmacies than 503B outsourcing facilities due to stricter regulations on 503B manufacturers. 503A pharmacies have less testing, or sometimes no testing, to verify their label claims. Our blog gives you a comprehensive look at the two. Read the Blog 3.

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Compounding Pharmacies Compounding Labelling Dosage 52

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In a Phase II study, CagriSema achieved a numerically higher body weight reduction of 15.6%

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98

Pharmaceutical Technology

JANUARY 15, 2023

In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children. The EMA also expanded the label of AbbVie’s Skyrizi (risankizumab) to include its use to treat moderate-to-severe Crohn’s disease.

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Labelling Packaging Communication Diabetes 52

Pharmaceutical Technology

DECEMBER 4, 2022

Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Others are made by big pharma giants like Boehringer Ingelheim , Novartis , or Pfizer , which has raised the expectations for a competitive market. .

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Biosimilars Labelling Communication Hospitals 104

Pharmaceutical Technology

JANUARY 6, 2023

Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

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Documentation Hospitals Dosage Drug Pricing 97

Pharmaceutical Technology

MARCH 20, 2023

Providing research companies with centralised distribution and procurement and the added value to rapidly move clinical trial material, manage biospecimen transportation, perform re-labelling and so on, will most definitely contribute positively to clinical supply chain outcomes,” comments van den Bergh.

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Communication Diabetes Labelling 52

Pharmaceutical Technology

DECEMBER 22, 2022

However, he did point out that the joint assessment could be a useful way of narrowing down typically broad EMA label content to specific patient populations. He believed that EUnetHTA’s conclusions will most likely influence the pricing and reimbursement decision of the drug at the national level.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Communication 52

Pharmaceutical Technology

JUNE 13, 2025

The US Food and Drug Administration (FDA) has approved the label expansion of AbbVie’s Mavyret (glecaprevir/pibrentasvir) for treating adults and paediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection. Credit: © AbbVie Inc. All rights reserved.

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Labelling Communication Hospitals Vaccines 52

Pharmaceutical Technology

JUNE 16, 2025

At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day.

Labelling 52

Labelling Communication Hospitals Vaccines 52

Pharmaceutical Technology

MARCH 6, 2023

Based on preclinical research for their impact on aging, well-known drugs like metformin and rapamycin are already being considered for off-label usage, due to their accepted safety profile and cost-effectiveness. Bellantuono worries that labeling aging as a disease indication could be “agist” and would have social implications.

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Labelling Communication Diabetes Pharmaceutical Companies 145

Pharmaceutical Technology

JANUARY 5, 2023

The pharmaceutical industry has long been labelled as a recession-proof—stable demand for medicines and new treatment options acts as a protective barrier. By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy.

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Drug Pricing Vaccines Labelling Communication 69

Pharmaceutical Technology

FEBRUARY 27, 2023

FDA decisions In December 2022, the FDA expanded the label for Novo Nordisk’s Wegovy (semaglutide), to include its use as an anti-obesity drug in adolescents with an initial body mass index over a certain threshold. The demand for Wegovy has been rising in recent times, with several reports on the drug’s shortages.

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Packaging Chemotherapy Labelling Communication 52

Pharmaceutical Technology

MARCH 21, 2023

A few weeks later, the EC extended the approval label of AstraZeneca’s Forxiga (dapagliflozin) to include the treatment of symptomatic hearth failure. FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older.

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Packaging Vaccines Labelling Communication 59

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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Pharmaceutical Technology

JUNE 16, 2025

By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. We may still continue to send you service-related and other non-promotional communications. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

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Insurance Coverage and Processing Communication Hospitals Vaccines 98

Pharmaceutical Technology

JUNE 13, 2025

Vaccines under political pressure Whilst the label expansion reflects an easing in regulatory tension surrounding mRNA vaccines under the Trump administration, FDA approval does not automatically mean shots enter national immunisation schedules. It also gained FDA approval a year before mRESVIA, giving it first to market advantage.

Vaccines 52

Vaccines Insurance Coverage and Processing Labelling Communication 52

Pharmaceutical Technology

JUNE 6, 2025

Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. ADHD treatments were in the political crosshairs in the US recently.

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Communication Hospitals Drug Pricing Packaging 52