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Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline

Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.

Biologics Legislation

House Democrats Launch Price Negotiation Push: Extreme Plan Assures Strong Opposition

Pelosi is moving forward with a draconian plan to limit US prices to an international benchmark. For now, the “bill” is a three-page outline subject to considerable legislative drafting – and so extreme as to rule out bipartisan compromise for the time being.

Pricing Debate Legislation

Drug Product Hopping Bill Should Specify Anti-Competitive 'Window', Congress Advised

House bill in the works to deter brand product switches should specify what behavior would be unacceptable, legal experts testify at congressional hearing.

Legislation Legal Issues

Curative Gene Therapy Coverage May Need Government-Funded Risk Pools

Former US FDA commissioner Scott Gottlieb makes a case for regional or national risk pools to ensure pediatric patients get timely access to gene therapy like the upcoming treatments for sickle cell disease.

Pricing Debate Policy

EU Court Advances Understanding Of SPC Patent Puzzle

Pharmaceutical companies will have a better idea of the conditions under which a supplementary protection certificate can be granted after an advocate general of the European court explained how a new legal test established last year should be used. However, lawyers caution that the opinion still leaves some aspects to be clarified.

Europe Intellectual Property

House Democrats And Price Negotiation: Slogan Is Unifying, But Policy Is Tougher

The most important thing to know about a draft version of the House Democratic leadership’s proposed drug price negotiation plan is that it is still just a draft – not the draft – much less a bill that could pass the Democratic controlled House, to say nothing of the GOP controlled Senate.

Pricing Debate Legislation
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