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Amphastar Continues To Push Proprietary Portfolio With Focus On Baqsimi

The Company Expects Several Regulatory Milestones In 2025

 
• By Adam Zamecnik

Amphastar’s leadership has discussed its strategy and latest results as part of a fireside chat at this year’s Jefferies Healthcare Conference, restating its expectations of potential approvals of its GLP-1 candidate in 2025.

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Amphastar is continuing in its shift towards a more proprietary portfolio through the development of new products with different delivery systems, as discussed in a fireside chat at this year’s Jefferies Healthcare Conference – which took place in London in late November – in which members of Amphastar’s management focused on the company’s latest results and recent efforts.

Attended by Amphastar’s executive vice president of corporate administration Jacob Liawatidewi and chief financial officer Bill Peters, the chat partly...

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Replacements Named As Eder Leaves Stada And Medicines For Europe

 
• By Dave Wallace

Stephan Eder has left Stada and stepped down as president of Medicines for Europe, with the company announcing plans for his replacement and the association naming Polpharma CEO Markus Sieger as the association’s new interim president.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Medicines For Europe Sets Out Vision For Biosimilars Reforms

 
• By Dave Wallace

Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.

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• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

Regeneron Monitoring Eylea Biosimilar Closely Following Innovative Setbacks

 
• By Dean Rudge

Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.