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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.

Kennedy attackerar dansk vaccinstudie – ”Propagandanummer från läkemedelsindustrin”

USA:s hälsominister Robert F. Kennedy Jr. uppmanar en medicinsk tidskrift att dra tillbaka publiceringen av en stor vaccinstudie, vars slutsatser han ogillar. M...

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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.

Trump in new push to lower drug prices

U.S. President Donald Trump announced on Sunday that he plans to sign an executive order to lower the cost of prescription drugs to the same levels paid in othe...

Aqilion's licensing journey: From Merck partnership to new opportunities

Be extremely meticulous with your scientific data, but spend just as much time and effort on business development. That piece of advice comes from Aqilion's CEO...

Björn Arvidsson will lead research and innovation in Region Uppsala

The Swedish life science profile Björn Arvidsson has been appointed Director of Research and Innovation for Region Uppsala.

Danish biotech to buy struggling American oncology company

Danish drugmaker Pharmacosmos has agreed to acquire American pharmaceutical company G1 Therapeutics in a deal that amounts to 405 million dollars.

Pharma Outsourcing – Find the Right Partner (2025)

Kvinna dog – J&J döms till miljardskadestånd

En jury i Los Angeles har dömt Johnson & Johnson (J&J) att betala motsvarande omkring 9,1 miljarder kronor till familjen till en kvinna som avlidit i mesoteliom...

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Strategic Clarity: The New Currency in Life Science

In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, ...

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.

Medivir CEO on upcoming study: ”It's about working together with others”

Medivir is a small company with a big task: to take its drug candidate, via extensive clinical studies, all the way to a patient group that currently lacks appr...

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...

Vaccine skeptic David Geier to lead study on link to autism

The American government is to launch a study on whether vaccines cause autism – and has appointed a well-known vaccine skeptic to lead the analysis.

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.

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...

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...

Ytterligare läkemedelskandidat mot Alzheimers droppas

Ett litet schweiziskt biotechbolag avbryter en fas II-studien med sin läkemedelskandidat mot Alzheimers sjukdom. Beskedet kommer inte långt efter att Biogen och...

First preterm infants study – a vital step for Neola

After years of developing an advanced lung monitoring system, Neola Medical has received some delightful news: permission to start its first clinical study on p...

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...

Licensavtal ska ge Roche nya vägar in i hjärnan

Läkemedelsbolaget Roche ska testa ett nytt sätt att transportera läkemedel till hjärnan – med hjälp av transportmolekyler från Bostonbaserade Manifold Bio.