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Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

Fierce Pharma

Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more (..)

Safety 249
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Microsoft’s Healthcare AI Efforts Holds Huge Promise for Patients

MedCity News

Called Microsoft Fabric, which was rolled out broadly in May, the announcement on October 10 marks the availability of Fabric’s capabilities specifically for the healthcare vertical – to clinicians, administrators but perhaps, most importantly, to patients. Lungs hyperinflated to clear. No pneumothorax or pleural eltusion.

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Do patients care about accelerated approval drugs?

World of DTC Marketing

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. Do patients care? The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012.

Patients 200
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Alzheimer’s drug requires strengthened pharmacovigilance approach

European Pharmaceutical Review

A paper published by the Drug Safety Research Unit (DSRU) in the British Journal for Clinical Pharmacology , has asserted the need for ongoing assessment of the safety and effectiveness of the Alzheimers drug lecanemab in the real-world clinical setting.

Safety 59
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FDA issues first recommendations on AI for drug development

European Pharmaceutical Review

The guidelines address the safety, effectiveness or quality of these medicines. With the appropriate safeguards in place, artificial intelligence has transformative potential to advance clinical research and accelerate medical product development to improve patient care.

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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. In this Q&A, EPR caught up with CEO James Short and Managing Director Arthur Wakeley from Celadon, to learn more about the company’s experience moving through, and progressing, the strict regulatory process for medicinal cannabis.

Medicine 132
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European authorities recognised for leading medicine regulatory oversight

European Pharmaceutical Review

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.