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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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Medicines For Europe Sets Out Trade Priorities

 
• By Dave Wallace

As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.

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.

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Biocon Agreement Provides Multiple Oncology Biosimilars To Malaysian Cancer NGO

 
• By Dean Rudge

Biocon Biologics will look to combine its “scientific expertise with the National Cancer Society of Malaysia’s strong community outreach and patient support network,” after signing striking up a partnership with the NGO providing for supply of three biosimilars.

Cigna Claims BMS Tied Revlimid Settlements to Pomalyst ‘Pay-for-Delay’ Scheme

 
• By Dean Rudge

Among other schemes, Cigna alleges that Celgene and parent Bristol Myers Squibb “paid” generic challengers – via lucrative Revlimid profit-sharing agreements – to delay generic market entry for Pomalyst until 2026, unlawfully extending their monopoly and overcharging purchasers.

US Supreme Court Requests Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.