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Latest From Vyera Pharmaceuticals, LLC

Anticompetitive Drug Rebates May Need FTC Rulemaking For Timely Reform, Commissioners Say

‘Rebate walls’ report heads to US Congress, but Democratic commissioners suggest FTC’s typical approach to curtailing such practices is too time consuming.

Legal Issues Legislation

FTC Commissioner Changes Could Impact Pharma Mergers, Scrutiny Of Biosimilars Uptake

President Biden’s picks to fill two commissioner posts may shift dynamics on pharmaceutical industry enforcement. Rohit Chopra’s nomination to Consumer Financial Protection Bureau removes strong critic of pharma mergers.

Enforcement Politics

CytoDyn's Leronlimab Suffers Refuse To File Letter; US FDA Concerned About Dosing, Manufacturing

US FDA declines to review the CCR5 antagonist for use in highly treatment-experienced HIV patients. Safety data from an ongoing study should be sufficient to address the agency’s concerns about the higher 700mg dose, CytoDyn management says, but FDA also has questions about the production of the self-injectable syringes.

Drug Review Infectious Diseases

FDA Approves First Generic Of Daraprim

Daraprim, which saw its price jacked up by 4,000% by former drug company executive Martin Shkreli, now has a competitor with the US Food and Drug Administration’s approval of the first generic version of the nearly seven-decade-old drug used to treat a life-threatening parasitic infection known as toxoplasmosis.

Generic Drugs Approvals
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