Remove tag clinical-documentation
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Drug-resistant epilepsy drug Ontozry backed by NICE

pharmaphorum

NICE notes in its final appraisal document (FAD) for the drug that many patients with this form of epilepsy may have to try a range of medicines, both alone and in combination, in order to control seizures. An opinion from the Scottish Medicine Consortium (SMC) on the use of the drug by NHS Scotland is expected to be published early in 2022.

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NICE says yes to Novartis’ multiple sclerosis therapy Kesimpta

pharmaphorum

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. While it requires a clinic visit, Ocrevus only has to be administered twice a year. billion in sales in 2028.

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NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group

pharmaphorum

” NICE asks for comments on its Appraisal Consultation Document (ACD) for #Risdiplam : [link] pic.twitter.com/SILXW9QFhZ. million price tag make it is the most expensive treatment ever approved for NHS funding, as it provides “exceptional benefit” to babies with the disease.

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Mounjaro (tirzepatide) alternatives: What can I take instead of Mounjaro?

The Checkup by Singlecare

Other GLP-1 receptor agonists (with indication for diabetes) If the price of Mounjaro or insurance coverage is not sustainable, the first move might be to find a GLP-1 drug with a lower price tag or better coverage on an insurance plan. There are limited clinical studies evaluating these effects. Novo Nordisk Inc.

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Moving to component management & traceability: progress, barriers, and the way forward

pharmaphorum

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them.

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Sanofi offers refunds for Cablivi in novel model for rebates

Pharmaceutical Technology

In an email to Pharmaceutical Technology , he further described the therapy as “the most important advance for treatment of TTP since the documentation of effectiveness of plasma exchange in 1991”. With these therapies, there is the possibility of there being no clinical benefit and an emergence of adverse events.

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How data is crucial to the relaunch of the Cancer Moonshot

pharmaphorum

During the first stage of the initiative, more than 2,000 research papers were published, 49 clinical trials were carried out, and more than 30 patents were filed through the support of the US National Cancer Institute (NCI). These datasets are critical as a means to identify how molecular information affects clinical outcomes.”