Patent Settlement Bill Advances - And Firms Fight Back With Examples Of Early Generic Launches That Would Be Prohibited

Four years ago, Teva inked a patent litigation settlement with Wyeth that enabled it to launch generic Effexor XR seven years before the patent on the drug expired

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Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
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MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.