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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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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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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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Pharma Outsourcing – Find the Right Partner (2025)
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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...
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Eli Lilly requests re-examination of Alzheimer's drug recommendation
Eli Lilly has requested that the EMA re-examine its opinion on the company's Alzheimer's drug, Kisunla, the agency announced on Friday.
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Fast Optical Sectioning of Developing Organisms and Tissue Microstructures
ZEISS Lattice SIM 3 exploits the full potential of the SIM Apotome technology.
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He takes over the chairmanship of Karolinska Development
Ben Toogood is appointed as the new chairman of Karolinska Developments.
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The dock that “thinks” for itself
The world of bulk material handling seems straightforward at first glance: moving, filling, delivering. However, the art of dealing with a variety of different ...
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Pharma Outsourcing – Find the Right Partner (2026)
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Sofia Wallström is Lif's new CEO
Sofia Wallström has been appointed as the new CEO of the industry organization Lif, the trade association for the research-based pharmaceutical industry in Sweden.
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Why the world renown researcher Marc Tessier-Lavigne resigns as Stanford´s president
In mid-summer, neuroscientist Marc Tessier-Lavigne announced his resignation as President of Stanford following allegations of manipulated study data. According...
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Trumps nya FDA-chef varnar för "massiv övermedicinering"
Donald Trump har nominerat kirurgen och författaren Marty Makary till ny chef för den amerikanska läkemedelsmyndigheten FDA, som enligt den tillträdande preside...
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The Swedish Research Council gets go-ahead for more long-term funding
Following a government decision, the Swedish Research Council will soon be able to approve ten-year grant periods for funding research infrastructure, which may...
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Scilifelabs nya direktör Jan Ellenberg: ”Spännande tid för life science”
I somras tillträdde Jan Ellenberg som ny direktör för Scilifelab. I en tv-intervju talar han om sin bakgrund, vikten av klustersamarbeten och sin tid som direkt...
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GSK fälls för inslag om RS-virus och vaccinering
Glaxo Smith Kline bröt mot kravet på vederhäftighet genom sitt budskap om risken för svår sjukdom till följd av RS-infektion hos personer över 60 år, enligt ett...
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Decades of research destroyed at KI – a hacker attack cannot be ruled out!
Years of research, together with half a billion Swedish krona, went up in smoke when the freezers at Karolinska Institutet overheated. The breakdown has now bee...
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Superconductor technology: Contactless working in the laboratory of the future
Automated filling and weighing of freeze-dry containers in the cleanroom with SupraMotion from Festo
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Redaktionens sommartips – böcker, poddar och tv-serier
Nu stundar sommar, semester och äntligen en chans att läsa den där boken, lyssna på den där podden eller se den där filmen som inte hanns med tidigare. Här tips...
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Rapid development in blood analysis – “Sweden is leading the race”
Thousands of analytical tests using just one single drop of blood. What was revealed as a hoax just a few years ago is now a reality, according to KTH professor...
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Forskning på prostatacancer gör Maréne Landström till Årets cancerforskare
Umeåforskaren Maréne Landström forskar på molekylära mekanismer som orsakar cancer. En specifik upptäckt har nu gett henne utmärkelsen Årets cancerforskare 2024.
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Failed to read the fine print – lost his life’s work
A celebrated CEO and co-founder of a pioneering lab company one moment – the next, fired, kicked out and written out of the company’s history. This is the story...
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Automated dispensing of a viscous hydrogel
A suitable solution developed for UPM Biomedicals In the Festo LifeTech Application Center we tested a setup for UPM Biomedicals for the automatic dispensing of...
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The TFS family is growing
TFS HealthScience is a European based CRO company with broad expertise and experiences in the biotech and pharmaceutical sector. The company is growing and the ...