The vaccine has saved 94 million lives – but measles is spreading again

A disease we once believed belonged to the past is now resurging in both Europe and the United States. In the shadow of growing skepticism and declining vaccina...

Tiden på väg att löpa ut för Pfizer i budstrid

Pfizers misslyckas med att juridiskt försöka stoppa Novo Nordisks uppköp av bioteknikbolaget Metsera. Den amerikanska läkemedelsjätten har nu två dagar på sig a...

Kennedy-rådgivare vill stoppa kombovaccin för barn under fyra

Barnvaccineringen i USA är under omprövning. På torsdagen beslutade CDC:s rådgivande vaccinkommitté (ACIP) att stoppa användningen av ett av landets viktigaste ...

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...

Eli Lilly värvar tidigare FDA-toppen Peter Marks

Tidigare vaccinchefen vid FDA, Peter Marks, värvas av läkemedelsbolaget Eli Lilly. En rekrytering som kritiserats hårt av hans efterträdare.

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...

First preterm infants study – a vital step for Neola

After years of developing an advanced lung monitoring system, Neola Medical has received some delightful news: permission to start its first clinical study on p...

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...

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)

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 ...

Svenske Martin Kulldorff bland nya vaccinrådgivare – utnämnd av Kennedy

USA:s hälsominister Robert Kennedy Jr. utsåg på onsdagen åtta nya ledamöter till CDC:s rådgivande vaccinkommitté (ACIP), efter att plötsligt ha avskedat hela de...

Pfizer värvar FDA-topp – kritiseras hårt

Läkemedelsjätten Pfizers rekrytering av Patrizia Cavazzoni, tills helt nyligen toppchef vid FDA, som ny medicinsk chef får frän kritik från flera håll.

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.

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...

Kennedy stoppar 22 projekt inom mRNA-vaccin – experter varnar för följderna

USA:s hälsodepartement avbryter finansieringen av 22 projekt som utvecklar mRNA-baserade vacciner, och växlar över till vad som hävdas vara ”säkrare och bredare...

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.

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

Patenttvist om covidvaccin löst genom miljarduppgörelse

En långdragen patenttvist om mRNA-baserade covidvaccin mellan Curevac och GSK å ena sidan och Pfizer/Biontech å den andra har nu lösts genom en överenskommelse mellan parterna.

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.

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 ...

Pfizer licensierar kinesisk cancerkandidat

Amerikanska Pfizer kommer få tillgång en experimentell cancerbehandling från kinesiska 3SBio genom ett nytecknat licensavtal.

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...

Wegovy approved in the U.S. for treatment of liver disease

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Novo Nordisk’s drug Wegovy to treat the serious liver condition known as MASH. ...