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FDA pushes Daiichi Sankyo’s quizartinib approval date by three months

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. AML makes up 23.1% of total leukaemia cases globally.

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Is DTC effective?

World of DTC Marketing

Among the 26% of respondents who talked to a health care provider about a specific prescription drug they saw advertised, 16% said they received a prescription for the advertised drug. Online research is used to evaluate new prescription drugs. The FDA can be myopic when researching how consumers view and react to DTC.

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Negative FDA AdCom vote for Intercept’s obeticholic acid in NASH

Pharmaceutical Technology

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

FDA 52
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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. Citizen Petitions before the FDA. 2 Submission of a Citizen Petition to the FDA obligates the regulator to address the arguments raised. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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GSK, Sanofi and Haleon ‘facing billions of dollars in Zantac liability’

pharmaphorum

GSK, its consumer health spin-off Haleon and Sanofi could be on the hook for billions of dollars in potential damages over Zantac, a gastrointestinal drug pulled from the market in 2020 after it was linked to cases of cancer. Some voluntarily took their products off the market as soon as the NDMA finding was reported by the FDA.

Sales 96
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Thursday pharma headlines

World of DTC Marketing

prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 million in 2020, more than double the number in 2015, according to health data company IQVIA. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S. Annual U.S.

Pharma 180
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10 New Solutions, Strategies, and Devices to Boost Adherence

PM360

According to an August 2021 report from the Business Research Company , after experiencing a decline in 2020 due to pandemic, the medication adherence market is expected to recover and grow at a compound annual growth rate (CAGR) of 11.4% This solution addresses the most common and costly reasons behind prescription abandonment.