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FDA Enforcement Discretion: A Strategic Path to Market for Digital Health and Digital Therapeutics Companies

Nixon Gwilt Law

Healthcare delivery is changing, and digital health is revolutionizing healthcare, creating a burgeoning market opportunity for software-as-a-medical-device (SaMD) and digital therapeutic (DTx) products. The FDA regulates all medical devices, including SaMD and DTx, but recognizes that not all pose the same level of risk to patients.

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The four biggest challenges facing DTC marketers

World of DTC Marketing

DTC marketing has evolved. Challenge #1 – DIGITAL MARKETING. Pharma companies are increasing digital budgets, but they are wasting too much money because of internal staffing issues and inexperience with online marketing. Paid Media – The most commonly used KPI in marketing is essentially worthless.

Marketing 196
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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. The voices in Washington DC are once again calling for a moratorium on DTC marketing but lawmakers need to understand what DTC marketing actually does as upped to what people believe it does.

Marketing 285
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DTC marketing is an oxymoron

World of DTC Marketing

QUICK READ: More TV DTC spots are airing, but DTC marketers are losing the battle between awareness and conversion because of all the noise online. I’ve spent the last six months analyzing clients’ DTC marketing campaigns and they are, for most ineffective. One of the most underused tactics is your product website.

Marketing 265
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Regeneron touts launch of high-dose Eylea in battle with Roche's Vabysmo

Fierce Pharma

Roche’s surge in sales for its long-acting macular degeneration drug Vabysmo showed that patients in the market are open to switching to another treatment. After gaining FDA approval for its high-dose Eylea, Regeneron racked up $43 million in sales in the U.S.

Sales 220
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Research predicts 2029 small molecule oncology market leaders

European Pharmaceutical Review

Strong demand for small molecules as treatment for non-small cell lung cancer (NSCLC) in the eight major markets means that the small molecule treatment market for the disease is expected to reach over $15 billion by 2029. This represents approximately 40 percent of the total NSCLC market, stated GlobalData. percent by 2029.

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The FDA and Aduhelm: WTF?

World of DTC Marketing

sales alone, which is above consensus estimates of around $7 billion to $8 billion, the team said. One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. I, therefore, find the FDA’s decision to be puzzling. history.”

FDA 218