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Daily Brief: Andrew Witty's replacement on Accelerated Access initiative, Blincyto gains full EU approval and more

The latest news from across pharma, biotech and healthcare

After Witty drop outs, Accelerated Access initiative gets new chair

An initiative to pick the very best new medical and tech innovations and fast-track them into the NHS has itself been stuck in the slow lane.

The Accelerated Access Collaborative (AAC) was meant to have started work in April, but since former GSK chief executive Sir Andrew Witty stepped down as its chair, the initiative has been stalled. The ex-pharma leader gave up the position to avoid any potential conflict of interest after accepting the CEO role at healthcare services firm Optum in March.

Now surgeon and former healthcare innovation-focused government minister Lord Darzi is to step into the role.

Lord Ara Darzi

Lord Darzi, Chair of the Accelerated Access Collaborative, said:

“Britain is world leading in medical science and research, but we need to make sure that people in the UK are able to reap the benefits of this innovation. It is vitally important that patients have rapid access to cost-effective, transformative treatments on the NHS. Doing so will not only improve the health of our patients, but will promote future collaboration between the life sciences sector and the NHS post-Brexit – benefiting the British economy and creating jobs.

I’m thrilled to be building on the great foundations laid by Sir Andrew Witty for the AAC to deliver this.”

The AAC looks unlikely to make a significant difference to uptake of new medicines, however, with its focus more likely to be on diagnostics and digital health technology.

Valeant shares tumble after FDA rejection

A rejection by the US regulator for Valeant’s plaque psoriasis treatment

Duobrii has sent the company’s share price tumbling.

The company’s shares fell 7% yesterday, and led analysts to question whether the company would have to revisit its forecasts for growth.

The company has a pipeline of candidates in its late-stage pipeline which it calls the “Significant Seven”, which it believes can generate more than $1 billion over the next five years.

Valeant said in a statement that the FDA had not specified any clinical efficacy or safety shortcomings in its Complete Response Letter, only raising questions about pharmacokinetic data, and that it would seek to resolve the matter quickly.

Blincyto gains full approval in Europe

Amgen’s leukemia treatment Blincyto, has been given full marketing authorisation in Europe, two years on from its first launch.

The novel immunotherapy was first granted conditional marketing authorisation in the EU in 2015 for the treatment of Ph- relapsed or refractory B-cell precursor ALL, but has now gained full approval thanks to new overall survival (OS) data.

The phase III TOWER study showed median OS was 7.7 months for Blincyto versus four months for standard of care (SOC). For patients treated in first salvage, the median OS was 11.1 months for BLINCYTO versus 5.3 months for SOC.

The drug gained similar approved at the end of March in the US.

David Reese

"Blincyto  is the first single agent immunotherapy to demonstrate superior overall survival benefit over standard of care," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen.

"For decades, overall survival has been the gold standard for assessing the efficacy of treatments for blood cancers. The near doubling of median overall survival versus standard of care seen in the TOWER study is groundbreaking and reinforces Blincyto as a highly effective ALL therapy, providing physicians with a much needed, efficacious treatment option, potentially offering patients the chance to live longer."

Another nailbiting Brexit vote in Parliament

Scarcely one week on from narrowly securing MPs backing for her Brexit plans, Prime Minister Theresa May faces another nailbiting vote in the Commons.

Pro-EU MPs in her own Conservative government will today attempt once again to secure a ‘meaningful vote’ on any final Brexit deal – after claiming that pledges made to them last week were misleading.

Meanwhile, leaders of the EU27 are warning of another breakdown in talks with the UK.  A leaked draft of conclusions for next week’s European council, warned member states and all stakeholders to “step up their work on preparedness at all levels for all outcomes”  - signalling that talks could reach an impasse on questions such as the Irish border and customs agreements.

Read more on Brexit:

Irish survey lists pharma firms' top five Brexit concerns

Article by
Andrew McConaghie

20th June 2018

From: Regulatory



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