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One Size No Longer Fits All: The Personalized Medicine Trial Landscape includes:
Medtech Insight
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.
Medtech Insight
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
Pink Sheet
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.
Pink Sheet
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.
Pink Sheet
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
Pink Sheet
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
Scrip
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
Scrip
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.
Datamonitor Healthcare
By Nicola Sawalhi-Leckenby 07 Sep 2018
Big changes are coming to the neuropathic pain market – are you prepared? Take a look at the projected neuropathic pain drug sales for the US, Japan, and five EU nations with the latest infographic from Datamonitor Healthcare. This snapshot view of the future of the neuropathic pain market is packed with data from the full Datamonitor Healthcare Neuropathic Pain Disease Coverage report.
Pink Sheet
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
Medtech Insight
By David Filmore 06 Sep 2018
The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.
Topic FDA
Scrip
By Jo Shorthouse 06 Sep 2018
Although 10 of Japan’s largest pharma companies look set to add $11bn in revenues over the next nine years, a CAGR of only 1% reflects an expected $4.8bn in patent expiries, leaving Japanese pharma heads relying on innovation for the next phase of the region’s major wins.
Topic Business strategies
Medtech Insight
By Catherine Longworth 06 Sep 2018
UK-based CMR Surgical has debuted its new portable robotic system Versius. "Inspired by the human arm,” it is expected to assist in surgeries on European patients beginning next year. Versius is set to rival Intuitive Surgical’s da Vinci robot systems, the current market leader in robotic surgery.
Topic Digital Health
In Vivo
By Ashley Yeo 06 Sep 2018
Drug delivery technology specialist Consort Medical has capitalized on device respiratory expertise for 50 years, but a renewed focus on strategic expansion has seen it make an IP play, move into the pharma side and target other delivery formats for global pharma industry customers. Its enhanced capabilities will keep rivals on their toes.
Topic Drug review Drug approval
Scrip
By Brian Yang 06 Sep 2018
“Winning the war without fighting. Using five types of fire attacks.” Sounds familiar? Sun Tzu's 2,000 year-old wisdom on the art of war is echoing down the ages, and winning in China today means that pharma needs to embrace a digital strategy more than ever before.
Topic Digital Health
Scrip
19 Sep 2018
Scrip
19 Sep 2018
Scrip
19 Sep 2018
Pink Sheet
18 Sep 2018
Medtech Insight
18 Sep 2018
Pink Sheet
18 Sep 2018
Pink Sheet
18 Sep 2018
Pink Sheet
18 Sep 2018
Medtech Insight
18 Sep 2018
Scrip
18 Sep 2018
In Vivo
18 Sep 2018
In Vivo
18 Sep 2018
Pink Sheet
18 Sep 2018
Scrip
18 Sep 2018
Scrip
18 Sep 2018
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