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...

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.

Sneak Peek of ZEISS Metrology Expert Tips Season 2

The second season of the video series starts in January 2026, but you can discover more about the highlights of Season 2 now.

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...

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...

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...

The Future of Metrology is Coming to Your Region

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Mercodia AB

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.

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

RISE - Research Institutes of Sweden

Gene therapy restored hearing in children with congenital deafness

Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...

Del 3 av Advance serien: Design

Ta reda på hur du kan omvandla en audit till en konkret lösning. Spirax Sarcos designfas ger dig allt du behöver för att implementera ett optimerat och framtids...

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...

GU Ventures AB

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...

Multiplex immunofluorescence chemistries with ZEISS tissue multiplexing workflow

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

Del 6 i Advance serien: Uppkopplade lösningar

Integrera våra produkter med era anläggningar och få kontinuerlig insikt i ångsystemets prestanda och driftseffektivitet.

Del 5 i Advance serien: Projektsupport & Driftsättning

Spirax Sarco säkerställer att alla system och komponenter levereras i full överensstämmelse med kundens operativa krav, från teknisk design och installation til...

New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”

Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...

New Horizons in Biologics & Bioprocessing incl. Advanced Therapies: Stockholm (2025)

Explore 3D Testing of Deformation and Motions

Powerful measurement capabilities with the new ZEISS ARAMIS 1.

Discover ZEISS ZEN core – now for electron microscopy

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New moves around Nykode's management – withdrawal of resignations

Norwegian Nykode Therapeutics is reinstating members of the management team who previously announced their resignations.