pharmaphorum

MARCH 30, 2021

There’s definitely the need to think more creatively and adaptively because the claim you want to put on your label may not be as straightforward to establish as it is for more traditional therapies.”. Read: Adelphi’s Transformational Value: Preparing for a Decade of Radical Change white paper. About the interviewees.

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ISPE

JULY 19, 2023

™” is becoming an increasingly rhetorical one, particularly in view of the growing momentum in the pharmaceutical industry and in various statements and white papers from key regulatory agencies. And finally, it should be acknowledged that the discussion of “why Pharma 4.0™” The upcoming Pharma 4.0™

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The FDA Law Blog

JANUARY 4, 2023

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.

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ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Table 1: Linkage among patient consideration, product design, target attributes and CQAs.

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ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Table 1: Linkage among patient consideration, product design, target attributes and CQAs.

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pharmaphorum

JANUARY 14, 2021

As interactive time with HCPs is likely to be scarce, companies need to be even more ruthless in prioritising content and in deciding what content to generate in the first instance – for example, in Real World Evidence, as outlined in IQVIA’s white paper, ‘Excellent Launches are winning the Evidence battle’ CNS (re) emerges.

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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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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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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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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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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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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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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

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

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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