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Cerner Enviza and FDA partner to develop AI drug safety tools

Pharmaceutical Technology

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies. Together, Cerner Enviza and John Snow Labs have all the right expertise, data and technology to make it happen.”

Safety 59
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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. They research the drug online and ask their physician about it if they decide it’s a treatment option. ” Patients want to understand how the drug works and the potential side effects before starting therapy. DTC ads do NOT lead to unnecessary Rxs.

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.

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MHRA warns of serious eye-related adverse events after Dupixent use

Pharmaceutical Technology

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

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FDA blocks early nod for Lilly’s Alzheimer’s drug donanemab

pharmaphorum

Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer’s disease therapy donanemab based on mid-stage clinical results, but says it remains on track to file a traditional submission around the middle of this year. Final results from CLARITY-AD are also due in the first half of this year.

FDA 62
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Is DTC effective?

World of DTC Marketing

How do physicians feel about patients asking for a new drug via a telehealth visit, and can the prescriber evaluate whether a patient is a good candidate or a new drug? What are the side effects? The FDA can be myopic when researching how consumers view and react to DTC. Is TV the best channel?

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Candela Medical Receives FDA Clearance for Vbeam 595 nm Pulsed Dye Laser, a Treatment for Port Wine Stains and Hemangiomas in Pediatric Cases

Legacy MEDSearch

3,6 It stops hemangioma growth, reduces the lesion, and accelerates hemangioma regression, especially in the superficial IH, without serious side effects. Port wine stains affect 1 in every 300 infants, and over time usually get darker and thicker, making early onset treatment critical for optimal results. Geronemus, M.D.,

Medical 52