Mediocre Vaccine Could Make Pandemic Worse, Non-Profit Group Tells US FDA
Ahead of the vaccine advisory committee, requests to FDA range from public health groups opposing emergency use authorizations to industry seeking labeling guidance on EUA products.
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Trump administration effort to reduce drug prices by curtailing agency program requiring new approvals for some old products undermines FDA’s role in policing the safety of prescription drugs, experts say.
Medicare actuaries indicate the ‘most-favored nations’ plan could limit patients’ access to medicine, though CMS’ Verma says she has confidence manufacturers won’t let that happen. Loss of access, combined with expected legal challenges, may make Democrats wary of embracing the Trump team’s last-minute rule, despite general agreement on the underlying policy idea. A Part D reference pricing policy is still in the works, CMS said.
Regeneron Calls For More Government-Funding of Biologic Manufacturing While Defending High Industry Prices
COVID-19 pandemic should finally spur US government to build biologic manufacturing capacity that would be ready for emergencies, Regeneron’s top leadership says. At the same time, the company leaders said the public doesn’t appreciate the value of industry’s private investments and needs to be more accepting of medications’ price points.