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Medtech Insight
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
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
By Cathy Kelly 21 Sep 2018
Even though measure was blocked in Congress, it may still advance through regulation.
Medtech Insight
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
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
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
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
21 Sep 2018
Medtech Insight
21 Sep 2018
Pink Sheet
21 Sep 2018
Scrip
21 Sep 2018
Medtech Insight
21 Sep 2018
Scrip
21 Sep 2018
Pink Sheet
21 Sep 2018
Medtech Insight
21 Sep 2018
Scrip
21 Sep 2018
Medtech Insight
21 Sep 2018
Medtech Insight
21 Sep 2018
Medtech Insight
21 Sep 2018
Scrip
21 Sep 2018
Pink Sheet
21 Sep 2018
Pink Sheet
21 Sep 2018
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