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Innehållstyper
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LINK Medical Research
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Acne medication may be the solution when hair starts falling out
A treatment originally developed for acne has shown remarkable Phase III results in a completely different area: male-pattern hair loss.
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New Horizons in Biologics & Bioprocessing incl. Advanced Therapies: Stockholm (2025)
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PMS, Vigilance and Risk Management
Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Un...
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IVDR Reality Check: Are We Moving Fast Enough?
As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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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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”Trickier than bacteria”: Why severe fungal infections are on the rise
There’s a reason Earth is sometimes called the planet of fungi. These ancient organisms – billions of years old and more closely related to animals than to plan...
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Many discontinue obesity medication – new study highlights the reasons
A new study maps out the most common reasons why patients choose to stop taking obesity medication prematurely. “Obesity medication discontinuation reverses hea...
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A cluster contribution to European life science innovation and competitiveness?
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“Access to capital increases when there’s an exit”
It remains a tough environment for biotech companies seeking financing – but there is good reason to hope for improvement ahead. That’s the view of Okee William...
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Novo Nordisk tells staff to return to office
At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...
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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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New Horizons in Biologics & Bioprocessing incl. Advanced Therapies: Copenhagen (2026)
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The vaccine has saved 94 million lives – but measles is spreading again
A disease we once believed belonged to the past is now resurging in both Europe and the United States. In the shadow of growing skepticism and declining vaccina...
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How the Nobel discovery is used in drug development
Regulatory T cells keep the immune system in check, a discovery now awarded the 2025 Nobel Prize in Physiology or Medicine. Qiang Pan Hammarström explains how t...
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Shaping the Future of Metrology – Live in Your Region
Insights into our event series.
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FDA launches investigation into gene therapy following child death
The U.S. Food and Drug Administration (FDA) has initiated a safety investigation into Takeda’s Adzynma after reports that a child has died during treatment. The...
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Southern Swedish company Aqilion develops drug for eosinophilic esophagitis
When Aqilion began developing a drug for eosinophilic esophagitis, the molecule was classified as an orphan drug. But the prevalence of the disease now appears ...
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Security flaw in Swedish breast cancer screening software – woman passed away
A lack of safeguard in Sectra's software led to a woman with breast cancer receiving an incorrect diagnosis. She later passed away. The software is used in 20 o...
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GU Ventures AB
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Shaping regulatory complexity into strategic clarity
As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data A...
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Agreement in the EU on eight years of data exclusivity for new medicines
New pharmaceuticals will be covered by eight years of data exclusivity, according to the proposed new pharmaceutical legislation that EU countries have now agre...
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Advanced workflow automation and scalable image analysis in spatial biology
ZEISS and Concept Life Sciences announce partnership.