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Clinigen Clinical Supplies Management GmbH

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...

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...

Ännu en alzheimerkandidat får snabbspår

USA:s läkemedelsmyndighet FDA har beviljat så kallad Fast Track Designation för ännu en läkemedelskandidat för behandling av tidig Alzheimers sjukdom.

Life science-bolag pitchade idéer i eget ”Draknästet”

Ett nytt event, arrangerat av Medicon Village, lockade investerare att höra presentationer från life science- och medtechbolag. ”Det fördes diskussioner om intr...

How the Nobel discovery is used in drug development

Regulatory T cells keep the immune system in check, a discovery now awarded the 2025 Nobel Prize in Physiology or Medicine. Qiang Pan Hammarström explains how t...

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.

GU Ventures AB

Advanced workflow automation and scalable image analysis in spatial biology

ZEISS and Concept Life Sciences announce partnership.

Tau-inriktat alzheimerpreparat får snabbspår i USA

Amerikanska Biogens alzheimerkandidat BIIB080 har beviljats ”Fast Track” – ett snabbspår – av den amerikanska läkemedelsmyndigheten FDA.

Tau-targeted Alzheimer's drug gets Fast Track designation in the USA

Biogen's Alzheimer's candidate BIIB080 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

New version of ISO 10993-1: the core standard for the biological evaluation of medical devices

ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...

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...

Falska studiedeltagare – ett växande hot mot forskningen

Digital rekrytering blir allt vanligare vid hälsorelaterad forskning, men samtidigt ökar problemet med falska deltagare. Det hotar både resultatens tillförlitli...

Mercodia AB

Swedish life science is growing – but capital is not keeping up

The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...

Pharma Relations AB

One System, Three Contrasting Techniques

ZEISS Axioscan 7 clinical - your digital slide scanner for diagnostics and clinical research.

Discover Precision: Join ZEISS at the Control Fair in Stuttgart

May 6-9, 2025 in Stuttgart. Hall 9, Booth 9309.

Är ditt ERP redo att växa med ditt företag?

Att växa som företag handlar inte bara om fler kunder och högre försäljning – det innebär också att möta nya krav och utmaningar. Men vad händer när ditt affärs...

New moves around Nykode's management – withdrawal of resignations

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

Del 4 i Advance serien: Produkter och system

Vi uppfyller dina specifika krav när standardlösningar inte räcker till.

Phosworks Digital Ideas