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1071 Total results for product and free and sample content found

Medtech Insight

Critical EU Authorities Meeting Next Week Could Be Make-Or-Break For Many Medtech Companies

By Sue Darcey 21 Sep 2018

The EU medtech industry is trying to put the brakes on the full application of the new Medical Devices and IVD Regulation as a logjam looms. What is it doing to succeed? And why is time running out?

Topic Medtech

Rose Sheet

CIR Recalculates Parabens Safety Margins; Will Expert Panel’s Confidence Be Shaken?

By Ryan Nelson 21 Sep 2018

The Cosmetic Ingredient Review’s newly figured margins of safety for single- and multi-paraben use in cosmetic products are dramatically lower than previous MOSs that informed the Expert Panel’s 2008 “safe as used” conclusions. Whether the panel still deems the MOSs sufficiently protective is the question going into the group’s Sept. 24-25 meeting.

Pink Sheet

DTC Ad Price Disclosure Provision Stripped From US Funding Bill

By Cathy Kelly 21 Sep 2018

Even though measure was blocked in Congress, it may still advance through regulation.

Topic Drug development landscape Drug approval

Medtech Insight

Payment 'Sunshine' Requirements Would Expand For Industry Under Senate-Passed Opioid Bill

By Sue Darcey 20 Sep 2018

A provision to expand Sunshine Act industry reporting requirements for companies in the Senate-passed “Opioid Crisis Response Act” has caught criticism from the device sector, despite overall industry support for the legislation.

Topic Drug review

Scrip

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

By Jo Shorthouse 20 Sep 2018

ICON’s CEO Steve Cutler talks candidly about the impact of biotech funding, disruptive tech providers, and the constant pressure of running one of the industry’s largest CROs.

Topic Company analysis

Scrip

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

By Anju Ghangurde 20 Sep 2018

Almirall's Ilumetri, licensed from Sun Pharma, has been cleared by the European Commission, upping the competition quotient in the psoriasis market and pitting the product directly against Johnson & Johnson's Tremfya.

Topic BioPharmaceutical

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.

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

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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