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Quality management system according to EN ISO 13485:2016 – in practice
Do you work with medical devices? Understanding and implementing a robust Quality Management System (QMS) is key to regulatory success—and often a prerequisite for CE-marking.
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How MoniDose strengthened their regulatory confidence—fast
When MoniDose began their startup journey, regulations were their biggest challenge. Missing early design inputs tied to standards could have meant costly redesigns later.
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GSK eyes blockbuster potential – plans five new trials
GSK sees blockbuster potential in its experimental drug candidate Mo-rez. Early trial results suggest the treatment may shrink tumours in patients with advanced...
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Sprint Bioscience builds the molecules that will become new medicines
In Sprint Bioscience’s laboratory in Flemingsberg, Huddinge, molecules are being created that no one has ever built before. The company specializes in preclinic...
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Nordic collaboration delivering the next leap in spatial biology
Spatial biology is reshaping how researchers understand complex tissue environments, from tumour–immune interactions to treatment response. A major barrier has ...
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First injectable cancer medicine for home use receives green light
Johnson & Johnson has announced that its blockbuster cancer medicine Darzalex (daratumumab) is set to become the first injectable cancer treatment in Europe sui...
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Drug approved for condition causing extreme hunger
The U.S. Food and Drug Administration (FDA) has for the first time approved a drug for acquired hypothalamic obesity, a condition marked by rapid weight gain dr...
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Lundbeck appoints Chief AI Officer
Danish pharmaceutical company Lundbeck has appointed Markus Kede as Chief AI Officer. He will join the Executive Leadership Team and report to President and CEO Charl van Zyl.
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Nya data för svensk CAR-T-terapi – ”Mycket lovande”
Sex av åtta patienter som behandlats med Eliceras CAR-T-cellskandidat ELC-301 uppnådde fullständig metabol respons (CMR) efter en månad, rapporterar bolaget.
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Han tar över E-hälsomyndigheten
Regeringen utser Kriminalvårdens överdirektör Peter Yngve till ny generaldirektör för E-hälsomyndigheten.
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“Ozempic babies” – myth or reality?
Have weight-loss drugs such as Ozempic led to a rise in unplanned pregnancies? Life Science Sweden takes a closer look.
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Thermo Fisher Expands in Sweden – “We Are Sending a Clear Message”
The American life science giant Thermo Fisher Scientific has inaugurated a new distribution center in Uppsala. “By investing in increasing our capacity as well ...
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Disappointment for Diamyd in Phase III – the share price plunges
Diamyd Medical’s share was sharply down on Monday following negative Phase III results. “This outcome is highly unexpected,” said the company’s CEO, Ulf Hannelius.
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ISO 13485 Standard Internal Auditing Course
Do you work with medical devices and quality management? Strengthen your expertise with our ISO 13485 Standard Internal Auditing Training — designed to give you...
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A food-based strategy to stop gut infections early
Most gastrointestinal infections are treated only after symptoms have already developed. Researcher Andreas Hougaard Laustsen-Kiel aims to reduce risk earlier b...
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Important notification for IVDR Class C device manufacturers
Deadline for application is quickly approaching; 26 May 2026.
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Supporting Investigator Initiated Clinical Studies—From Start to Finish
Many important clinical studies start with researchers – not pharmaceutical companies. In investigator initiated studies, pharmaceutical companies often support...
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Are you prepared for the updated ISO 10993 1:2025?
The latest edition of ISO 10993-1 reinforces the integration of biological evaluation with risk management, introduces updated approaches to exposure assessment...
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Lost in the recruitment process? How hiring really works today
As recruitment becomes increasingly automated, candidates are expected to adapt to both human and algorithmic decision-making. Career coach Tina Persson outline...
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Transport validation for medical devices
According to MDR 2017/745, “Devices shall be designed and manufactured in such a way as to ensure that their characteristics and performance during their intend...
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Anna Törner: Sänker FDA kraven på kliniska data?
Är den amerikanska läkemedelsmyndigheten FDA på väg att sänka ribban för att godkänna nya läkemedel? Den frågan ställer sig Anna Törner i en krönika – där hon o...
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Lungforskningsbolag kan andas ut efter fulltecknad nyemission
Medicinteknikbolaget Pexa har beslutat att upprätta kontrollbalansräkning – men genomför också en fullt garanterad företrädesemission för att återupprätta sitt aktiekapital.
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Cinclus welcomes FDA announcement on single‑study requirement
Swedish Cinclus Pharma welcomes the signals from the United States that a single pivotal study, rather than two, may be sufficient when applying for market approval.
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Asgard teaches tumours to self‑destruct – moving closer to clinical trials
Swedish biotech Asgard Therapeutics not only has an evocative name, but also a remarkably exciting approach to cancer treatment: getting tumour cells to reprogr...
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