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...

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.

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...

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...

A cluster contribution to European life science innovation and competitiveness?

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...

Many discontinue obesity medication – new study highlights the reasons

A new study maps out the most common reasons why patients choose to stop taking obesity medication prematurely. “Obesity medication discontinuation reverses hea...

Lillys GLP-1-tablett nådde målen i typ 2-diabetesstudie

Läkemedelsbolaget Eli Lilly meddelar positiva resultat för GLP-1-tabletten orforglipron i två fas III-studier med typ 2-diabetespatienter.

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...

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...

Anocca raises SEK 440 million ahead of clinical cancer trial

Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.

The New Precise Magazine is Available Now

Download the new issue.

Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”

Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...

In search of Marcel Proust's lost health

A great writer, but also a weak person and a hypochondriac. That has been the usual image of Marcel Proust. But the pediatrician and literary scholar Carl Lindg...

Del 2 av Advance serien: Audits och rådgivning

Ingen grön omställning utan en översikt. Audits ger dig exakt de mätvärden och rekommendationer som du behöver för att optimera både verksamheten och koldioxidavtrycket.

Studie: Biomarkörer förutser hjärt-kärlkomplikationer vid typ 2-diabetes

Epigenetiska biomarkörer kan förutsäga vilka personer med typ 2-diabetes som riskerar att få hjärt-kärlsjukdomar, enligt en ny studie från Lunds universitet.

ZEISS unveils AI-powered Research Data Platform

Collaboration with Boehringer Ingelheim champions the future of personalized eye care.

Avhopp i Kennedys vaccinkommitté inför första mötet

Efter att ha sparkat samtliga experter i USA:s vaccinkommitté och tillsatt åtta nya, står hälsominister Robert F. Kennedy Jr. nu med en ofullständig panel. En m...

Organize and Manage Digital Classrooms

Create engaging lessons with ZEISS Labscope Teacher.

Medical Plastics Tips & Tricks

Measuringhero video by ZEISS.

Pulsen på patientförbunden del 2: Postcovid

Trots att forskningen kring postcovid gjort stora framsteg på senare år är kunskapsluckorna många. Svenska Covidföreningen ser ett akut behov av fler läkemedels...

New drug to simplify treatment of hemophilia

A new type of treatment for hemophilia, which only needs to be administered every two months, has been approved by the U.S. Food and Drug Administration (FDA).

RegSmart Life Science AB

Scientific Solutions