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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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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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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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An organ seldom in the spotlight – but utterly vital
The kidneys consist of more than 40 types of cells and have more functions in the body than most people know. Julie Williams leads AstraZeneca’s work in preclin...
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Studie motbevisar Kennedys påstående om sparkad vaccinkommitté
Den vaccinkommitté som avskedades av Robert F. Kennedy Jr. i början av juni hade lägst nivå av ekonomiska intressekonflikter sedan 2000, visar studie. Tvärtemot...
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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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Advanced workflow automation and scalable image analysis in spatial biology
ZEISS and Concept Life Sciences announce partnership.
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Novartis storsatsar på RNA-terapier – köper miljardbolag
Novartis förvärvar amerikanska Avidity Biosciences för 12 miljarder dollar, motsvarande 113 miljarder kronor. Köpet stärker bolagets position inom sällsynta mus...
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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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Vaccinskeptiker ny ordförande för amerikansk covid-kommitté
Enligt professor Retsef Levi kan mRNA-vacciner orsaka allvarlig skada och död och bör därför omedelbart dras tillbaka. Nu har han utsetts till att leda arbetsgr...
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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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How to avoid measurement inaccuracies due to wear
Expert tip from ZEISS.
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Billion-Dollar Deal Sends BioArctic Soaring
Swedish Alzheimer-focused company BioArctic has entered into a licensing collaboration with Novartis regarding a technology aimed at enhancing efficient drug de...
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ZEISS at EMO Hannover 2025
Experience some of the most exciting highlights from our ZEISS product portfolio.
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Automated nitrogen analysis reduces costs per sample
N-Realizer analytical system from C. Gerhardt increases productivity with valve block from Festo
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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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Xbrane enters licensing agreement with Indian generics giant
Swedish biosimilar developer Xbrane Biopharma and the Indian company Intas Pharmaceuticals have entered into a license and co-development agreement.
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Kennedy petar samtliga vaccinexperter – tillsätter egen kommitté
Robert F. Kennedy Jr. har avskedat samtliga 17 medlemmar i en expertpanel om vaccin vid USA:s smittskyddsmyndighet CDC. En ny grupp experter ska tillsättas av h...
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GSK acquires oncology research company
GSK acquires the American biotechnology company Idrx for up to 1.15 billion dollars.
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FDA approves new cystic fibrosis therapy
A new treatment for cystic fibrosis has been approved by the U.S. Food and Drug Administration (FDA).
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The art of successful licensing – “A lot has to align”
Sharp research, strong data and a high level of innovation are all very good, but more than that is required to achieve the goal of many biotechnology companies...
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Anocca raises SEK 440 million ahead of clinical cancer trial
Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.
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Webinar: Support Trial Patients Transitioning to the Commercial Space
Register for expert insights on supporting Phase III clinical trial patients post-approval and read our blog on advanced Patient Assistance Programs.
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Kennedy stoppar 22 projekt inom mRNA-vaccin – experter varnar för följderna
USA:s hälsodepartement avbryter finansieringen av 22 projekt som utvecklar mRNA-baserade vacciner, och växlar över till vad som hävdas vara ”säkrare och bredare...