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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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Astra Zeneca’s asthma drug nears approval for sinus inflammation
Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.
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Health politician Lina Nordquist: ”I find it hard to be idle”
She is the pharmacist and researcher who grew tired of the breakthroughs that never materialised and knowledge that never seemed to reach patients, so she decid...
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Mercodia AB
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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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Genmab to Acquire Dutch biotech for USD 8 Billion
Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.
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Ny svängning – Trump hotar med 100-procentiga tullar på läkemedel
USA kommer att införa 100-procentiga tullar på importerade läkemedel, såvida inte bolagen bygger fabriker på amerikansk mark, uppger president Donald Trump.
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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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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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DBB ventiler: Snabbare installationer och färre skarvar
Spirax Sarco Safebloc är en lösning med en unik platsbesparande design som innebär snabbare installation och färre skarvar. Spirax
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Getinge and Neobiomics received Swecare's export awards
Two companies received awards during Swecare's annual conference.
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Öresundsinstitutets vd: Novo Nordisk i aktiekris snarare än företagskris
Nedskärningarna på Novo Nordisk väcker frågor i hela den nordiska life science-sektorn. Men enligt Johan Wessman, vd för det dansk-svenska kunskapscentret Öresu...
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Investment CEO: “The Nordics are outstanding in creating successful medtech companies”
Since the beginning of last month, Susanna Francke Rodau has been a partner and the new CEO of Segulah Medical Acceleration, which invests in medical technology...
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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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AI automates testing of implant coatings
The medical technology group Smith+Nephew uses an AI-supported light microscope ZEISS Axio Imager to inspect coated implants.
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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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Improve Productivity and Accessibility with Award-winning Human-Centered Design
Enhance your workflow with integrated intelligence.
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Novo Nordisk to invest billions in new quality control lab
Novo Nordisk has announced plans to invest 2.9 billion Danish kroner in order to establish a new quality control laboratory in Hillerød in northern Zealand, Denmark.
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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...
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Eli Lilly Recruits Leading Swedish Researcher Kaj Blennow to Head Alzheimer’s Project
Eli Lilly recruits Kaj Blennow, leading Alzheimer’s researcher, as VP of neuroscience biomarker development.
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Meribel Pharma Solna
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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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New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”
Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...
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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...