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.

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, ...

Agreement in the EU on eight years of data exclusivity for new medicines

New pharmaceuticals will be covered by eight years of data exclusivity, according to the proposed new pharmaceutical legislation that EU countries have now agre...

Genmab to Acquire Dutch biotech for USD 8 Billion

Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.

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...

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...

IVDR Reality Check: Are We Moving Fast Enough?

As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...

Vaccine project targeting congenital infection scrapped in late-stage trial – “Clearly disappointed”

Hope for the first vaccine against the world’s most common congenital infection has taken a serious hit

Could an overly burdensome QMS be the organization’s own doing?

Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...

Venomaid's rapid test aims to find the right snake bite treatment

Every six seconds, someone on our planet suffers a snake bite, and each time, a race against the clock begins. What kind of snake was it, and which antivenom ca...

US Health Secretary Kennedy dismisses all vaccine experts – assembles new committee

Robert F. Kennedy Jr. has dismissed all 17 members of the CDC’s vaccine advisory panel. A new group of experts will be appointed directly by the Health Secretar...

Swedish team tests Alzheimer antibody for brain imaging

Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...

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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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...

Mikael Kubista back with new venture after turbulent exit

Entrepreneur and researcher Mikael Kubista is starting a new company. Now he is also free to comment on the sequence of events that led to him losing ownership ...

Virology professor on the threat from X: ”The next pandemic could be worse“

The question is not if, but when we will be affected by a new unknown virus that causes yet another pandemic. Are we sufficiently prepared? "Absolutely not!", r...

ZEISS EVO as the Key to Wire Technology in Modern Medicine

High-performance wires for stents.

Advanced workflow automation and scalable image analysis in spatial biology

ZEISS and Concept Life Sciences announce partnership.

From pharmacist to life science podcaster – Magnus Lejelöv uses his voice as a tool

Magnus Lejelöv has more than 20 years of experience in the pharmaceutical industry and has conducted nearly two hundred interviews with healthcare professionals...

FDA approves Gilead’s HIV injection: “Historic day”

Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...

Multiplex immunofluorescence chemistries with ZEISS tissue multiplexing workflow

Bringing leading multiplex immunofluorescence chemistries together in one automated 8-channel imaging platform.

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.

Lund University’s record-breaking recruitment – attracting researchers from around the world

The Swedish university is launching its largest international recruitment effort ever, aiming to hire 25 researchers globally, including several in the medical field.