Regulatory Recap: AAM Looks To Confirmed HHS Secretary RFK Jr. To Fix ‘Broken System’

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Generics Bulletin reviews the latest regulatory developments across the world.

Regulatory Recap
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“Making America healthy and keeping America healthy depends on access to affordable, reliable medicine,” said John Murphy III, president and CEO of the Association for Accessible Medicines, as the Department of Health and Human Services welcomed its confirmed leader Robert F. Kennedy Jr.

RFK Jr. has been a controversial pick for the HHS secretary role given his anti-vaccine rhetoric, which he has denied...

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Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

 
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After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.

MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
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The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 

Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.