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Astra Zeneca pauses multi-million investment in the UK
Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.
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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
, it may signal what’s ahead for medical devices.
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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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Vaccine project targeting congenital infection scrapped in late-stage trial – “Clearly disappointed”
Hope for the first vaccine against the world’s most common congenital infection has taken a serious hit
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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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Astra Zeneca fryser miljardinvestering i Storbritannien
Astra Zeneca har pausat en planerad investering på motsvarande 2,5 miljarder kronor. Det är det senaste läkemedelsbolaget som drar tillbaka sina satsningar i Storbritannien.
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Canada approves leqembi as global alzheimer’s drug race heats up
Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...
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Kanada godkänner Leqembi – racet om alzheimerläkemedel hårdnar
Leqembi får godkännande i Kanada och stärker därmed sitt globala försprång. Läkemedlet är nu godkänt på 15 större marknader – en mer än rivalen Kisunla.
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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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Antikroppar från lama hjälpte mot 17 olika ormars bett
Ett motgift baserat på antikroppar från en lama och en alpacka lyckades neutralisera gift från några av världens mest giftiga ormar i en preklinisk studie.
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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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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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Exakt flödeskontroll för krävande industrier – med lösningar från Brooks Instrument
OEM Automatic erbjuder flödesmätare och regulatorer från Brooks Instrument – en globalt erkänd aktör inom mätning och reglering av gas- och vätskeflöden. Med öv...
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How to Assure Quality within R&D Medical Devices
Free webinar on June 3rd, 2025, 9:00 - 9:45 AM CEST and 5:00 - 5:45 PM CEST.
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ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment
Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.
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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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The First Multi-Technology System from ZEISS
Microscope and measuring machine in one.
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Alzinova får FDA:s snabbspår för sitt alzheimervaccin
Biofarmabolaget Alzinovas vaccinkandidat mot Alzheimers sjukdom har beviljar Fast Track-status av USA:s läkemedelsmyndighet FDA.
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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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Quality assurance for research and development of medical devices
Overcome the hurdles of research, development, and QA lab environments within the regulated medical technology industry.
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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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Klartecken för Eli Lillys alzheimerläkemedel i EU – blir konkurrent till Leqembi
EU-kommissionen gör tummen upp för alzheimerläkemedlet Kisunla från Eli Lilly, som därmed blir den andra godkända bromsbehandlingen för sjukdomen i EU.
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GBA Key2compliance rekryterar Camilla Oldgren till ny vd
Från och med den 1 juni är det Camilla Oldgren som leder konsultföretaget GBA Key2compliance.
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