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Medtech Insight

Start-Up Spotlight: Creavo Medical, Diagnosing Myocardial Ischaemia With MCG

By Cathering Longworth 12 Sep 2018

UK medtech company Creavo Medical is trying to bring its magnetocardiography (MCG) technology to emergency departments worldwide for speedier diagnosis of heart disease. Distinguishing between ischemic heart disease and non-cardiac chest pain remains a challenge in emergency departments. Currently, all patients presenting with chest pain are assessed with electrocardiography and blood tests to rule out heart disease, but almost three-quarters of patients with chest pain do not have a cardiac-related condition.

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Medtech Insight

Medtronic Slapped With 2 FDA Warning Letters For Problems At Minnesota, Puerto Rico Sites

By Shawn M. Schmitt 12 Sep 2018

Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.

Topic FDA

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Pink Sheet

The Tricky Task Of Bringing Smaller EU Countries Into The Fold

By Maureen ​ Kenny 12 Sep 2018

Clusters of excellence, competition as well as co-operation, Brexit, and aiming high. Danish Medicines Agency head Thomas Senderovitz talks national agencies and engagement in an interview with the Pink Sheet.

Topic Brexit Drug development landscape Drug approval

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Pink Sheet

Clearer Purpose And Direction Needed For EU Agency Heads Network

By Maureen ​ Kenny 12 Sep 2018

Thomas Senderovitz will chair the management group of the EU Heads of Medicines Agencies for at least the next two years. The Danish regulator tells the Pink Sheet of his big plans for the network.

Topic Business strategies Company analysis

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Pink Sheet

Brexit Likely To Force Refocusing Of Ambitious EU Network Strategy

By Maureen ​ Kenny 12 Sep 2018

The European Medicines Agency and drug regulators throughout the EU are having to invest huge amounts of time and effort in dealing with the fall-out from Brexit - and it hasn't even happened yet. Plans for working together on bigger issues agreed on a few years ago will likely have to change, senior regulator Thomas Senderovitz tells the Pink Sheet.

Topic Brexit Business strategies

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Pink Sheet

Big Data In Medicines Regulation Will Need ‘Considerable Change In Mindset’

By Maureen ​ Kenny 12 Sep 2018

Changing mindsets, technologies outpacing regulatory frameworks, intense international collaboration, and the future of the randomized controlled clinical trial. Big data is forcing us to think big, senior European regulator Thomas Senderovitz tells the Pink Sheet.

Topic Brexit Business strategies

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Scrip

Tech Transfer Roundup: How To Protect Downstream Rights

By Joseph Haas 12 Sep 2018

A review of tech transfer deals over 10 years shows that licensees often protect their value positions to limit royalties paid out to licensors. Meanwhile, licensors often protect their future rights with language recognizing that additional parties may be involved in producing a final product.

Topic Digital Health

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Scrip

Multiple Myeloma: A Growth Market Set To Shrink As Revlimid Generics Hit

By Mandy Jackson 12 Sep 2018

Despite several new entrants to the multiple myeloma market, Datamonitor Healthcare forecasts that drug sales between 2017 and 2026 will peak in 2022 when Revlimid generics hit the market. J&J's Darzalex will become the new best-seller, but generate a fraction of Revlimid's sales.

Topic Cancer Drug development landscape

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Pink Sheet

Kymriah: England Becomes First In Europe To Say Yes To CAR-T

By Neena ​ Brizmohun 06 Sep 2018

A new deal between Novartis and England’s National Health Service is one of the fastest funding approvals in the 70-year history of the NHS.

Topic Cancer

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