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AAM Urges US Senate To Back Domestic Production

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.”

Manufacturing United States

FDA Re-Evaluates Orange Book Patents

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.

Intellectual Property Regulation

Alvogen Group Unveils Adalvo B2B Unit

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.

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AAM Urges US Senate To Back Domestic Production

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.”

Manufacturing United States

Celltrion Selected For Korean-Made Insulin Biosimilar

Korean firm Celltrion is aiming to move production of insulin pens inside Korea “for the first time” and break the stranglehold of Big Pharma insulin players in the market by launching a biosimilar product in 2025.

Biosimilars Strategy

Mylan And Lupin Prepare To Launch EU Etanercept

Mylan and Lupin have revealed when they expect to launch their etanercept biosimilar, Nepexto, in Europe after receiving formal European Commission approval.

Biosimilars Approvals
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Value-Added Medicines Explore this Topic

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Alvogen Group Unveils Adalvo B2B Unit

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.

Strategy Manufacturing

Value-Added Specialist Hyloris Launches IPO

Value-added medicines specialist Hyloris Pharmaceuticals is launching an IPO to provide the funds it needs to focus on opportunities through the US 505(b)(2) pathway.

Strategy Value-Added Medicines

Virpax And MedPharm Advance Diclofenac Spray

Virpax Pharmaceuticals and partner MedPharm say they have made progress towards filing through the US 505(b)(2) hybrid pathway a diclofenac spray for treating osteoarthritis of the knee.

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