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FDA’s new CSA guidance: transforming software validation for production and quality systems
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.
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Career coach on salaries: “There is no right or wrong”
What is a reasonable salary for my job? It's a question we all ask ourselves. But how important is a higher salary really? Career coach Tina Persson believes th...
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Charged with illegal pharmaceutical sales – alleged earnings of 23 million
For at least five years, two men allegedly carried out illegal sales of pharmaceuticals and supplements, amassing millions. They are now facing charges at Söder...
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Phase III win for Hansa Biopharma: “We Are Thrilled”
Swedish biotech Hansa Biopharma’s transplant drug imlifidase has met the primary efficacy endpoint in a registration-enabling Phase III study in the United States.
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Därför är SEO inte dött: “Viktigare än någonsin”
AI förändrar hur vi söker information – men grunden för att synas på nätet är densamma. För bolag inom biotech och life science är SEO särskilt viktigt: "Förtro...
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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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Bio Europe intar Stockholm i höst – ”Det svenska ekosystemet tar nu tillfället i akt”
Den internationella life science-konferensen Bio Europe kommer i november för första gången till Sverige. Konferensen, vars program tar inspiration av ABBA-låta...
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Could an overly burdensome QMS be the organization’s own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...
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Heart Monitoring in Breast Cancer – Essential or Excessive?
Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...
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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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Hjärtövervakning vid bröstcancer sätts under lupp
Trastuzumab och efterföljande läkemedel har revolutionerat bröstcancervården och ökat överlevnaden markant. Men övervakningen av patienter för hjärtbiverkningar...
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Explore the possibilities of the new ZEISS METROTOM 800 320 kV
Free ZEISS webinar July 10, 9:00-9:45 AM and 5:00-5:45 PM.
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Pneumatics Makes a Technological Leap with Piezo
The first high-precision proportional valve terminal VTEP opens up new application areas
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Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”
Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...
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Falska studiedeltagare – ett växande hot mot forskningen
Digital rekrytering blir allt vanligare vid hälsorelaterad forskning, men samtidigt ökar problemet med falska deltagare. Det hotar både resultatens tillförlitli...
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ZEISS receives FDA clearance for INTRABEAM 700
With its new treatment platform for intraoperative radiotherapy, ZEISS is actively shaping the medical innovation of neuro tumor therapy.
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Anna Törner: ”If I fall seriously ill, I’ll move to Finland”
”It is both undignified and undemocratic that cancer patients must travel to Finland to uphold a façade of fairness that does not truly exist”, Anna Törner writes in a column.
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FDA approves Gilead’s HIV injection: “Historic day”
Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...
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ZEISS introduces the new Smartzoom 100
The future of digital microscopy for efficient optical inspections.
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Life science trends 2025 – The economy
Upcoming patent expirations are driving pharmaceutical companies to acquire in 2025. In Sweden, we may be on our way to brighter times and fewer bankruptcies. T...
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Virology professor on the threat from X: ”The next pandemic could be worse“
The question is not if, but when we will be affected by a new unknown virus that causes yet another pandemic. Are we sufficiently prepared? "Absolutely not!", r...
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Pneumatics Makes a Technological Leap with Piezo
The first high-precision proportional valve terminal VTEP opens up new application areas
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Sensorer som lossnar och buggar i appar – fler klagomål på medicinteknik
Läkemedelsverkets nya e-tjänst för anmälan av problem med medicintekniska produkter har lett till en markant ökning av rapporter från privatpersoner. Särskilt m...
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ZEISS Lightfield 4D for instant volumetric high-speed imaging
Capturing physiological and neuronal processes in 3D.
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