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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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Datamonitor Healthcare

Neuropathic Pain Market and Forecast Analysis to 2026

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.

View infographic
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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Medtech Insight

'Quik' Review Program Builds On US FDA eSubmission Efforts

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

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Scrip

INFOGRAPHIC: Patent Losses Characterize Japan's Challenging Pharma Future

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

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Medtech Insight

CMR Surgical Launches Robotic System To Rival Intuitives Da Vinci

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

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In Vivo

Broader Capabilities Keep Consort On Top At Device End Of Drug Delivery

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

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Scrip

Art Of War: Why Pharma Must Do Digital Dance In China

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

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Latest headlines

Scrip

19 Sep 2018

Spectrum To Test Poziotinib's Potential As First Line Treatment Of Exon 20 Mutant NSCLC

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Scrip

19 Sep 2018

ICON CEO: CROs Must Be Aware Of Threat Posed By Big Tech

Link
Scrip

19 Sep 2018

Executives On The Move: New CEOs Vaxil Bio and Akero Therapeutics, with Some Big Pharma Execs Joining Smaller Companies

Link
Pink Sheet

18 Sep 2018

Biosimilar Sponsors: We Need To Do A Better Job Educating Physicians And Patients

Link
Medtech Insight

18 Sep 2018

French Supreme Court Finalizes PIP Fraud Rulings And Executive Sentencings

Link
Pink Sheet

18 Sep 2018

Northern Ireland Improves Access To Cancer Drugs Fund Treatments

Link
Pink Sheet

18 Sep 2018

Repeated Questions Prompt EMA To Reconsider Guidance On Neonates

Link
Pink Sheet

18 Sep 2018

Ukraine To Start Disclosing Clinical Trial Results

Link
Medtech Insight

18 Sep 2018

MIACH Orthopedics Score NFLPA Investment For ACL Repair Tech

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Scrip

18 Sep 2018

Tildrakizumab Set For Europe Debut - Can It Make A Dent?

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In Vivo

18 Sep 2018

Gene Therapy: Spark Charts A Course From Science To Payer And Patient Satisfaction

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In Vivo

18 Sep 2018

Spark Therapeutics: Calculating The Price Of A Cure

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Pink Sheet

18 Sep 2018

AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

Link
Scrip

18 Sep 2018

Novo Nordisk Cuts 400 Jobs In R&D Reshuffle As It Broadens Its Horizons

Link
Scrip

18 Sep 2018

Viking’s Liver Fat Reduction Data Portend A New Competitor In NASH

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Pharma Intelligence latest insights

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

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

The Tricky Task Of Bringing Smaller EU Countries Into The Fold

Clearer Purpose And Direction Needed For EU Agency Heads Network

Brexit Likely To Force Refocusing Of Ambitious EU Network Strategy

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

Tech Transfer Roundup: How To Protect Downstream Rights

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

Neuropathic Pain Market and Forecast Analysis to 2026

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

'Quik' Review Program Builds On US FDA eSubmission Efforts

INFOGRAPHIC: Patent Losses Characterize Japan's Challenging Pharma Future

CMR Surgical Launches Robotic System To Rival Intuitives Da Vinci

Broader Capabilities Keep Consort On Top At Device End Of Drug Delivery

Art Of War: Why Pharma Must Do Digital Dance In China

Latest headlines

Spectrum To Test Poziotinib's Potential As First Line Treatment Of Exon 20 Mutant NSCLC

ICON CEO: CROs Must Be Aware Of Threat Posed By Big Tech

Executives On The Move: New CEOs Vaxil Bio and Akero Therapeutics, with Some Big Pharma Execs Joining Smaller Companies

Biosimilar Sponsors: We Need To Do A Better Job Educating Physicians And Patients

French Supreme Court Finalizes PIP Fraud Rulings And Executive Sentencings

Northern Ireland Improves Access To Cancer Drugs Fund Treatments

Repeated Questions Prompt EMA To Reconsider Guidance On Neonates

Ukraine To Start Disclosing Clinical Trial Results

MIACH Orthopedics Score NFLPA Investment For ACL Repair Tech

Tildrakizumab Set For Europe Debut - Can It Make A Dent?

Gene Therapy: Spark Charts A Course From Science To Payer And Patient Satisfaction

Spark Therapeutics: Calculating The Price Of A Cure

AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

Novo Nordisk Cuts 400 Jobs In R&D Reshuffle As It Broadens Its Horizons

Viking’s Liver Fat Reduction Data Portend A New Competitor In NASH

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