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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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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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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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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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Genmab drops another ADC candidate from billion‑dollar ProfoundBio deal
Danish biotech Genmab has discontinued development of its antibody‑drug conjugate (ADC) candidate GEN1160, citing low patient enrollment in an early‑stage cancer trial.
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Gene therapy restored hearing in children with congenital deafness
Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...
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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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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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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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Swedish team tests Alzheimer antibody for brain imaging
Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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Swedish life science is growing – but capital is not keeping up
The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...
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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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Roche joins Medicon Village
Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...
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Allogene discontinues investigational antibody following patient death
U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pi...
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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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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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Norway rejects national life science strategy – sees no need
The Norwegian Arbeiderpartiet rejects a proposal that Norway should develop its own life science strategy.
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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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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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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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New moves around Nykode's management – withdrawal of resignations
Norwegian Nykode Therapeutics is reinstating members of the management team who previously announced their resignations.
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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 Mellander, Director General...
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She is CSL Behring's new Nordic General Manager
Since the beginning of january, Helena Bragd is the new Nordic General Manager for the biotech company CSL Behring and CEO of CSL Behring AB.
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