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FDA approves Ipsen’s Bylvay for cholestatic pruritus due to ALGS

Pharmaceutical Technology

Bylvay is a once-a-day, non-systemic ileal bile acid transport inhibitor (IBATi) that acts locally in the small intestine and has minimal systemic exposure. The therapy is being offered immediately through prescription for eligible ALGS patients. More than 90% of patients who received treatment with odevixibat were pruritus responders.

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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. It emphasises its ability to make information interoperable with electronic health systems such as e-prescription and electronic health records. Therefore, POD is not a viable alternative to paper leaflets.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

They inform industrial scientists what is necessary to ensure that their product meets the safety and efficacy requirements to get a product approved in humans. They may be therapeutically as effective, but the safety aspect is a key concern in approving biosimilarity.”. Following QbD to guarantee a drug product's safety.

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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.

Medical 105
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Embedding the Patient Point of View in Everything You Do

PM360

People get tired of feeling that they are their sickness; they’re tired of carrying the baggage of being a “patient,” and they want to be seen and treated like the person they are, not the prescription they take. This is a tangible human challenge. Empathy needs to be a core strategic imperative for pharma brands.

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

Clarify Health

After the fact, they also have to navigate obtaining any follow-up referral appointments, filling prescriptions, and paying their bill. And the researchers found that older and sicker patients were twice as likely to find and report an error — which they said indicates even more severe safety and care quality implications.

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A Primer on Telepharmacy

Nixon Gwilt Law

North Dakota State University conducted a study in 2002, known as the North Dakota Telepharmacy Project, to evaluate the safety and efficacy of telepharmacy and found that it [telepharmacy] was as safe or safer than other forms of traditional pharmacy services. How Does Telepharmacy Work in Practice? Remote verification.

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