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Innehållstyper
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Mercodia AB
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New version of ISO 10993-1: the core standard for the biological evaluation of medical devices
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...
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The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...
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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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Ännu en alzheimerkandidat får snabbspår
USA:s läkemedelsmyndighet FDA har beviljat så kallad Fast Track Designation för ännu en läkemedelskandidat för behandling av tidig Alzheimers sjukdom.
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Life science-bolag pitchade idéer i eget ”Draknästet”
Ett nytt event, arrangerat av Medicon Village, lockade investerare att höra presentationer från life science- och medtechbolag. ”Det fördes diskussioner om intr...
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Advancing Drug Discovery by Combining Complex In-Vitro Models with AI-Powered 3D/4D Image Analysis
Free webinar organized by ZEISS.
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HAB Nicolai Johannsen
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Scientific Solutions
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A+ Science AB
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Tau-inriktat alzheimerpreparat får snabbspår i USA
Amerikanska Biogens alzheimerkandidat BIIB080 har beviljats ”Fast Track” – ett snabbspår – av den amerikanska läkemedelsmyndigheten FDA.
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ProPharma
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Tau-targeted Alzheimer's drug gets Fast Track designation in the USA
Biogen's Alzheimer's candidate BIIB080 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
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QPS Netherlands B.V
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Clinigen Clinical Supplies Management GmbH
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How the Foreign Office will promote Swedish life science exports
The broadness and innovative strength keep Swedish life science exports strong, but the protectionist tendencies in the world are worrying, says Camilla Melland...
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Pharma Relations AB
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GSK pays 2.2 billion dollars to settle Zantac lawsuits
British drugmaker Glaxo Smith Kline, GSK, has struck a 2.2 billion dollar settlement, thereby resolving a vast majority of the liability cases pending against t...
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CTC Clinical Trial Consultants AB
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Bio Europe to Stockholm – ”The Swedish ecosystem is now taking the opportunity”
The international life science conference Bio Europe is coming to Sweden for the first time in November. The conference, whose program takes inspiration from AB...
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Rise and Scantox cease conducting animal testing in Stockholm
Access to in vivo toxicology services is significantly decreasing in the Stockholm area as Rise shuts down animal testing and Scantox reorganizes. ”The costs ar...
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Q-lineas testinstrument får grönt ljus av FDA – ”Kommer göra verklig skillnad för patienter”
Uppsalabolaget Q-linea har fått ett marknadsgodkännande från den amerikanska läkemedelsmyndigheten FDA för sin huvudprodukt Astar, ett instrument för test av an...
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Svenska inkubatorer med på lista över ledande europeiska startup-hubbar
Flera svenska startup-hubbar placerar sig på lista över ledande europeiska inkubatorer och acceleratorer. Smile Incubator, Umeå Biotech Incubator och Karolinska...
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Nordic Regulatory experts: Improving biotech chances of Succ
Why is it that so many biotech companies fail? And what are the tools needed to change that fact?
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