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While the AAM is lobbying for a renewed focus on domestic drug production amid fresh concerns about the globalization of the US pharmaceutical drug supply chain, the association has urged US Congress to have confidence in FDA oversight, insisting that “the US has one of the safest drug supply chains in the world.”
With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.
The Alvogen group of companies has unveiled Adalvo as the new identity for its B2B business unit. In an exclusive interview, general manager Anil Okay talks to Generics Bulletin about the reasons behind the rebranding, what makes it unique in the B2B sphere, and the significance of 2023 for Adalvo’s strategy.
A CJEU advocate general has backed a European Commission fine of almost €94m imposed on Lundbeck over “pay for delay” deals struck with four generics firms over citalopram.
Meitheal has launched enoxaparin in the US following its FDA approval towards the end of last year.
The FDA wants to know if the second letter in its product equivalence ratings system is helpful and whether changes could make the information more user-friendly.
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