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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. Source: STAT News Our healthcare system can’t continue to support drugs that don’t have good clinical outcomes behind them. Not to mention the $56,000 annual price tag.

Drugs 218
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Immunocore’s Kimmtrak Gets FDA Approval as First Treatment for Rare Eye Cancer and First T Cell Receptor Therapeutic

XTalks

The company is expecting approval from the European Medicines Agency (EMA) soon as it prepares for a European launch in the second quarter of this year. Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose. The median treatment time is about 23 weeks (or 5.3

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Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

XTalks

Consequently, there is a critical role for diagnostics to play in addressing this global health challenge,” said Matt Sause, CEO of Roche Diagnostics, in the company’s news release. “We “The incidence of dementia is growing worldwide, with 75 percent of cases remaining undiagnosed.

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Merck KGaA raises full-year forecast; Perlmutter’s new gig tackles ‘undruggable targets’

The Pharma Data

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. . cases, vaccinations continue to drop as White House sets new inoculation goal ( CNBC ). New Scottish Agency Would Ensure Supply Of Cost-Effective Drugs ( Pink Sheet ). Posted 05 May 2021 | By Kari Oakes .