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Roche To Work On Reversing English Funding Rejection For SMA Drug

But Tecentriq Gets NICE Thumbs Up For NSCLC

 
• By Neena Brizmohun

Evrysdi could follow Spinraza and Zolgensma to become the third treatment for spinal muscular atrophy available on England’s National Health Service if Roche can agree on a lower price for the drug.

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
Roche needs to offer a price for Evrysdi that is cost-effective for the NHS • Source: Alamy

Roche has pledged to work to reverse NICE’s preliminary decision this week that its spinal muscular atrophy (SMA) treatment, Evrysdi (risdiplam), should not be made available to patients on England’s National Health Service because it is too expensive.

In draft guidance published by the health technology assessment (HTA) body, NICE said that while it agreed that the...

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Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

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Respiratory Treatments Hit Hardest By HTA Terminations In England

 
• By Leela Barham

Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
• By Eliza Slawther

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

More from Europe

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 
• By Francesca Bruce

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.

EU Pharma Reform Package Clears Big Political Hurdle After Council Adopts Position

 
• By Neena Brizmohun

The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.