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Biden Infrastructure Plan Offers Biopharma R&D Carrot, Tax Stick

Tens of billions would go to fund R&D, including Phase I and Phase II development of vaccines. But the plan would also crack down on inversions and offshoring.

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Aducanumab Review: Looking For Precedents – Long Ago And Far Afield

The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.

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Spike In Drug Recalls Expected As US FDA Resumes Inspections, Targeting COVID-19-Related Problems

Attorneys and recall consultants say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.

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Experts Predict Spike In Drug Recalls As US FDA Inspections Resume

Legal experts say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.

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