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As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

Fierce Pharma

But these immunotherapies also come with various potentially dangerous side effects. | A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions.

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Unfair balance

World of DTC Marketing

It’s time to admit that the FDA is completely out of touch regarding DTC advertising. I just finished an analysis of a pharma clients website using their analytics. Who could blame them when the safety information sounds like a medical journal? For some reason, the FDA still requires fair balance on website home pages.

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Thursday pharma headlines

World of DTC Marketing

The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S. COVID Dashboards.

Pharma 180
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Elements of a great pharma website

World of DTC Marketing

6ix: Safety information needs context. In clinical trials, how many people experienced a listed side effect? They understand that patient content could be edited to meet FDA requirements, but they like reading others’ experiences managing their health issues. 9ine: “Why aren’t pharma websites updated?”

Pharma 180
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Navigating the Regulatory Environment of Pharmaceutical Marketing: Balancing Patient Safety and Industry Innovation

Pharma Marketing Network

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

Safety 52
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The debate on DTC marketing is going to heat up again

World of DTC Marketing

The FDA needs to study what people do when they see a DTC ad. 3hree: DTC marketing minimizes the side effects of prescription drugs – One of the top pages within prescription drug websites continues to be “safety information.” SUMMARY: DTC marketing is not the reason why prescription drugs cost so much.

Marketing 285
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FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Pharma Leaders

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.