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FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The reason for this review extension was undisclosed in the announcement. people per every 100,000 individuals in the US.

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The internet enables misinformation on COVID

World of DTC Marketing

While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. A big source of mistrust in the COVID-19 vaccine comes from the speed at which it was produced.

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How Pharmacogenomics may finally realise its promise

pharmaphorum

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. The best way to do that is to target specific sub-populations, which will serve as a natural lead into personalised medicine becoming more mainstream. billion in the United States alone.

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FDA accepts review of SeresTx BLA for oral microbiome therapeutic

pharmaphorum

Additionally, SeresTx’s BLA has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) target date of 26 th April 2023. In July 2021, Swiss food giant Nestle paid $175 million upfront for North American co-marketing rights to SER-109.

FDA 44
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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

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Two Key Questions About Adherence/Compliance in 2022

PM360

Furthermore, when providers rely on self-reporting, they may be receiving inaccurate data, such that providers may erroneously acknowledge a patient’s filled prescription as evidence of adherence. Measuring and monitoring adherence in clinical trials would add valuable information about the effectiveness and safety of drugs.

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The key to better patient journey mapping: Breaking down data silos

Clarify Health

For the patient, this can lead to improved patient experience, better-informed patient outreach efforts, and a higher-quality care experience overall. After the fact, they also have to navigate obtaining any follow-up referral appointments, filling prescriptions, and paying their bill. Ensuring interoperability.