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Deucravacitinib Shows Joint, Skin Symptom Improvements in Psoriatic Arthritis

Drug Topics

POETYK PsA-1 is a randomized, double-blind, placebo-controlled phase 3 trial evaluating the efficacy and safety of deucravacitinib compared to placebo in adult patients with PsA who are naïve to biologic disease-modifying anti-rheumatic medications. of patients who received placebo. References 1.

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Significant Knowledge Gap Exists in Patient Awareness of Psoriatic Disease

Drug Topics

Significantly linked with psoriasis, PsA is a chronic skin and nail disease 3 that impacts up to 30% of patients with psoriasis. 5 Despite these advancements in treatment options, the management of PsD remains a challenge for providers looking to improve their patients’ QOL. References 1. Albreiki F, Alfalasi A, Al-Otaibi M, et al.

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Ardelyx’s ambition to revolutionise kidney treatment

pharmaphorum

The company’s lead candidate Tenapanor is a targeted, small molecule therapy currently under FDA review. As the pandemic surged this year, the disruption of healthcare systems posed a significant challenge for patients receiving kidney care. Patients who undergo dialysis are some of the most fragile.

FDA 104
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DSCSA Postponement And What It Means For Independent Pharmacies

DiversifyRx

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

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CDRH Seeks Public Comment on How to Increase Patient Access to At-Home Use Medical Technologies

The FDA Law Blog

As acknowledged in the Strategic Priorities document, certain demographic groups may have limited access to necessary treatments and diagnostics. FDA defines a Home Use Device as “a medical device intended for users in any environment outside of a professional healthcare facility.

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How common are changes to the primary endpoint in oncology RCTs?

Hospital Pharmacy Europe

A recent analysis suggests changes to primary endpoints occur frequently in randomised clinical trials in oncology, representing a risk of suboptimal – or even potentially harmful – patient care, together with outcome reporting bias. Rod Tucker investigates what this means for clinicians.

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How a new investment is powering a revolution in clinical trial operations

pharmaphorum

We’re trying to register lifesaving therapies, but we have to collect the data manually, and often the FDA and EMA inspectors have to visit trial sites to validate the data. When I first started working in clinical trials, people were just moving from paper documentation to EDCs,” Peleg says. It’s simply a waste of resources.”.