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Pricing Deals Spell Good News For Exkivity & Vimizin In England

 
• By Neena Brizmohun

Access to Takeda’s lung cancer drug, Exkivity, is being fast-tracked, and BioMarin’s Vimizin, for mucopolysaccharidosis type 4A, is switching to routine use after what the MPS Society called “a long and at times difficult journey.”

Pile of British money pounds sterling new one pound coins GBP in four piles close-up with NHS above. Rising cost of National Health Service concept UK
The NHS says the deals it has struck make the drugs affordable • Source: Alamy

Exkivity (mobocertinib) is to be fast-tracked to eligible lung cancer patients in England within weeks, and Vimizin (elosulfase alfa) will now be made routinely available for treating a rare life-limiting metabolic disorder, after the National Health Service brokered pricing deals for the drugs.

Exkivity, which the NHS called “gamechanging,” is Takeda Pharmaceutical’s first-in-class, oral tyrosine kinase inhibitor (TKI) for patients with EGFR Exon20 non-small cell lung cancer (NSCLC), a rare and aggressive...

More from United Kingdom

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.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
• By Neena Brizmohun

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Europe

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.