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NICE Backs Xgeva for Oncology But Excludes Prostate Cancer Indication

 
• By Faraz Kermani

A significant discount from Amgen has left NICE more than happy to pass Xgeva, but it still found economic grounds to reject the company’s application for a prostate cancer indication.

In a rare occurrence for any drug navigating its way through the UK’s reimbursement system, Amgen Inc.’s Xgeva (denosumab) for the treatment of skeletal events in some cancer patients has fairly flown through the National Institute for Health and Clinical Excellence’s evaluation process. Although the company did not get everything it wanted from the health-cost regulator, the discount Amgen offered the NHS means that it can now rest assured that the uptake of Xgeva is only a brief matter of time.

NICE gave the thumbs up to Xgeva as an option for preventing skeletal-related events, including pathological fracture, radiation to bone, spinal cord compression or surgery to bone, in adults with...

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More from Europe

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

More from Geography

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.