Amphastar Continues To Push Proprietary Portfolio With Focus On Baqsimi

 
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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.

The Generics Bulletin Podcast: Recent And Upcoming Industry Events

 
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Generics Bulletin’s editorial team discusses recent conferences held by Medicines for Europe and the AAM, while looking ahead to the key off-patent industry events that are on the calendar over the next few months and beyond.

Europe Must Not Squander Potential Of Reformulation

 
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At a panel on value added medicines at Medicines for Europe’s 30th annual conference in Dublin, Pharmanovia CEO and value added medicines sector chair James Burt set out the case for expanding the scope of current EU pharma legislation proposals to reward reformulation alongside repurposing.

The View From The Top: European CEOs Highlight Industry Priorities

 
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At a high-profile panel closing out Medicines for Europe’s 30th annual conference in Dublin, six industry leaders set out their views on key topics including pricing, regulation, sustainability, and stakeholder communication.


European Solutions To European Problems – Securing The Supply Of Critical Medicines

 
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European solidarity and dialogue will be key as the region seeks to secure its supply of critical medicines, says Victor Mendonça, board member of Medicines for Europe. In an exclusive interview, he speaks to Generics Bulletin about what can be done to strengthen Europe’s supply chain without “one country’s solution being another country’s problem.”

European Alliance Should Lead To Critical Medicines Act, Says Industry

 
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The European Critical Medicines Alliance must lead to a Critical Medicines Act to support the off-patent industry and help reduce shortages, Medicines for Europe believes.

‘A True Seat At The Table’ – Irish Industry Leader Sets Out Aspirations For New Pricing Deal

 
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With a fresh pricing deal on the horizon, Medicines for Ireland chair and Teva country head Paul Neill talks to Generics Bulletin about the need for the Irish off-patent industry to have “a true seat at the table” and secure an agreement with the country’s government that better reflects the specificities of the generics and biosimilars market.

‘We Tried It, It Does Not Work’ – The Problems With The EU’s SPC Manufacturing Waiver

 
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While the European supplementary protection certificate manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.


‘We Tried It, It Does Not Work’ – The Problems With The EU’s SPC Manufacturing Waiver

 
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While the European SPC manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.

Medicines For Europe Highlights Sector Challenges As It Celebrates Milestone Anniversary

 
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At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.

Taking European Biosimilars To The Next Level

 
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Europe’s biosimilars market now has many years of progress under its belt. But how can this successful foundation be built upon to make the most of the opportunities on the horizon and achieve even greater access and uptake? In an exclusive interview, Generics Bulletin talks to Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil about the next steps.

European Progress On Biosimilars Is Just The Beginning

 
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Speaking at Medicines for Europe’s 20th annual biosimilar medicines conference, Isabell Remus, chair of Medicines for Europe’s biosimilar medicines sector group, looks to the future for European biosimilars over the next decade and outlines the potential that can be realized – but only if a comprehensive strategy for biosimilars is put in place.


‘You Step Up, You Bring Things Back To Market’: CDER’s Corrigan-Curay On Shortages

 
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Principal deputy director of the US FDA’s Center for Drug Evaluation and Research, Jacqueline Corrigan-Curay, used part of her 20-minute keynote address at the recent AAM Access! annual conference to focus on drug shortages that persist across the US.

The Long Read: CEOs Unplug At AAM Conference

 
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The AAM’s annual Access! 2024 conference brought its much-enjoyed CEOs Unplugged panel to Tampa again for another engaging discussion on critical issues, challenges and opportunities for generics and biosimilars in the US.

‘Is The Market Now Sustainable? The Answer Is Still Not’: AAM’s Haruvi On The Need To Fix The US Generics Industry

 
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Dramatic downward pressure on prices will continue to impact supply for an industry already reeling from shortages, the Association for Accessible Medicines’ newly appointed chair Keren Haruvi tells Generics Bulletin during an exclusive interview on the sidelines of the association’s recent annual conference in Tampa.

ATOM Coalition Seeks Partners To Create New Oncology Markets

 
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The ATOM Coalition is seeking partners in the generics and biosimilars industry to help create new markets for cancer medicines in LLMICs.


IGBA Seeks To Underline Value And Access

 
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Speaking with Generics Bulletin at the IGBA’s annual conference in February, chair Jonathan Kimball explained how the association is conveying the value of generics and biosimilars to international industry stakeholders.

IGBA Aims To Take The Fight To Originators On Trade Deals

 
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 With a permanent structure in place and a trade principles paper recently updated, the IGBA believes it is well placed to argue the case for promoting accessible medicines in international trade negotiations versus the interests of the originator industry.