The FDA Law Blog

OCTOBER 10, 2022

Certainly we would expect clinical communications, as well as HCP-patient communications, to include discussions of test results over time as these would seem highly relevant to clinical decision making. The final guidance focuses on labeling as a means to effectuate Criterion 4. software or labeling.

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Pharmaceutical Technology

DECEMBER 16, 2022

This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19. By downloading this Whitepaper, 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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Labelling Communication FDA 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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Labelling Pharmaceutical Companies Pharmaceutical Companies Communication 144

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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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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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 FDA Communication 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%

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Insurance Labelling Communication FDA 105

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%

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Insurance Labelling Communication FDA 98

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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Vaccines Labelling Communication 69

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 FDA Vaccines Labelling 59

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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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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Labelling Communication Hospitals FDA 104

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 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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