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Dear FDA: WTF?

World of DTC Marketing

SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs. The post Dear FDA: WTF?

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Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

Legacy MEDSearch

Food and Drug Administration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. BabySat is a step forward in solving some of these exact challenges by bringing real-time medical grade infant monitoring into the home, while under the supervision of a physician. Are you hiring?

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The debate on DTC marketing is going to heat up again

World of DTC Marketing

SUMMARY: DTC marketing is not the reason why prescription drugs cost so much. The FDA needs to study what people do when they see a DTC ad. Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. DTC ads raise awareness around health conditions.

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FDA grants approval for Amylyx’s Relyvrio to treat ALS

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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US FDA accepts Optinose’s sNDA for chronic rhinosinusitis therapy Xhance

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.

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Edelman Trust Barometer raises questions

World of DTC Marketing

Trust, for example, in physicians is still relatively high. Most patients completely trusted their physicians “to put their needs above all other considerations” (69%). Physician trust in the U.S. Physician trust in the U.S. Even patients will still line up if a prescription drug shows promise.

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FDA approves Ipsen’s Bylvay for cholestatic pruritus due to ALGS

Pharmaceutical Technology

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). The therapy is being offered immediately through prescription for eligible ALGS patients.