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Amylin’s Bydureon Approval: How Does It Sit With Novo Nordisk?

 
• By Wendy Diller

Sponsor of the leading GLP-1 agonist, Victoza, sees the launch of the long-acting competitor from Amylin as having a class-wide impact, drawing more patients to GLP-1s – and it thinks that it can stave off the once-weekly contender.

Competitors see the U.S. approval of Amylin Pharmaceuticals Inc.’s type 2 diabetes drug Bydureon (long-acting exenatide) on Jan. 27 as an event that will boost interest in the entire GLP-1 class, benefiting other agents as well.

Novo Nordisk AS has come out swinging in the wake of Amylin’s long-time-coming success, and it will be interesting...

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More from Germany

CSL Makes Landmark National-Level Pay-For-Performance Deal In Germany For Hemgenix

 
• By Francesca Bruce

A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.

German Ordinance To Implement HTA Reg Leaves Room For Doubt

 
• By Francesca Bruce

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 
• By Eliza Slawther

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

German Agency’s 2025 Plan Highlights EU HTA Reg, Long Covid And Smoking Cessation Drugs

 
• By Francesca Bruce

An ordinance came into effect on 8 March to ensure that joint clinical assessments can be incorporated into the German pricing and reimbursement system.

More from Europe

UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 
• By Francesca Bruce

Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

 
• By Vibha Sharma

The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.