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The FDA and Aduhelm: WTF?

World of DTC Marketing

One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. Therefore, I find it hard to understand how so many physicians could show “strong interest” in prescribing a drug with so many questions vs. answers. government.

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Is it too late for Biogen?

World of DTC Marketing

Never mind that physicians have turned against the drug Biogen wants to fight the decision because of their business needs. While some doctors have been eager to start prescribing the newly approved drug, others had criticized the FDA for clearing the drug before studies proved it works. Top researchers who advised the U.S.

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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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Wegovy hype driving demand

World of DTC Marketing

The demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. There are also several physicians chiming in with their concerns over the long-term use of the drug. I reached out to some physicians to ask their opinion, and it varied. Unfortunately, the hype is going to exceed reality.

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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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EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory GERD

Legacy MEDSearch

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

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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. During the two-year project, the companies will assess the mental health side effects of the asthma drug, montelukast.

Safety 59