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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Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

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.

Computed tomography in measurement of medical plastic products

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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...

Moderna develops mRNA vaccine against norovirus

A highly anticipated vaccine is in late clinical evaluation and could be ready for approval within a couple of years. The target is the norovirus, often called ...

Abbvie förvärvar lovande projekt inom psykisk ohälsa

Abbvie köper ett läkemedelsprogram inom mental hälsa i en miljardaffär som ser lite annorlunda än vad som tidigare uppgetts.

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...

“Research is always a lot of failures and a few successes”

Gene therapies open up fantastic possibilities, but they are also extremely expensive to produce. Genenova aims to change that and make the treatments accessibl...

The Future of Swedish & Danish Life Science (2026)

Large study: The benefits and risks of obesity medications

Medications such as Ozempic can reduce the risk of a range of different diseases and health conditions but also increase the risk of others. This is according t...

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...

Pharma Outsourcing – Find the Right Partner (2025)

Ancient DNA provides new insights – “The immune system lost its job”

Ancient bone remains from our ancestors have provided new insights into the prevalence of multiple sclerosis. By looking back in time, researchers can provide a...

Who pays for Rebecca Doe – and all of us?

Anna Törner on how easily we get used to the idea that healthcare is free - when it really is about how and who pays for it

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.

GSK pays 2.2 billion dollars to settle Zantac lawsuits

British drugmaker Glaxo Smith Kline, GSK, has struck a 2.2 billion dollar settlement, thereby resolving a vast majority of the liability cases pending against t...

Takeover bid is being completed – Japanese company acquires Calliditas

Japanese company Asahi Kasei completes the bid for Calliditas Therapeutics after reaching over 90 percent of the shareholding. Callidita's board has now decided...

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...

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...

Abbvie ryktas överväga miljardförvärv inom mental hälsa

Läkemedelsbolaget Abbvie uppges föra diskussioner om att förvärva Gilgamesh Pharmaceuticals, ett bolag inom mental hälsa, i en affär som ska ligga på omkring en miljard dollar.

Studie: Totalresistenta Klebsiella-bakterier mycket smittsamma

Totalresistenta Klebsiella-bakterier som undersökts i krigets Ukraina bar på gener som gör dem mer smittsamma, enligt en studie från Lunds universitet. ”Skrämma...

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...