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 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...

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...

Trump in new push to lower drug prices

U.S. President Donald Trump announced on Sunday that he plans to sign an executive order to lower the cost of prescription drugs to the same levels paid in othe...

Heart Monitoring in Breast Cancer – Essential or Excessive?

Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...

Novo Nordisk tells staff to return to office

At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...

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...

Alzinova får FDA:s snabbspår för sitt alzheimervaccin

Biofarmabolaget Alzinovas vaccinkandidat mot Alzheimers sjukdom har beviljar Fast Track-status av USA:s läkemedelsmyndighet FDA.

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

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. ...

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...

Charged with illegal pharmaceutical sales – alleged earnings of 23 million

For at least five years, two men allegedly carried out illegal sales of pharmaceuticals and supplements, amassing millions. They are now facing charges at Söder...

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...

Källor: Novo och Lilly nära prisavtal med Vita huset

Amerikanska läkemedelsbolaget Eli Lilly och danska branschkollegan Novo Nordisk förbereder sig för att tillkännage nya prisavtal för läkemedel i en uppgörelse m...

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 ...

Alzinova tar steg mot fas II-studie i USA

Biofarmabolaget Alzinova hoppas kunna inleda en fas II-studie med sin vaccinkandidat mot Alzheimers under andra halvåret 2025.

Johan Pehrson takes over the responsibility for research policy in Sweden

The Liberals' party leader Johan Pehrson takes over the assignment as Minister for Education. This was announced by Prime Minister Ulf Kristersson (M) on Tuesday last week.

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.

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New findings on the diseases that crushed Napoleon’s army

As if cold, starvation, and typhus weren’t enough. New research reveals that Napoleon’s defeated army also suffered from paratyphoid fever and relapsing fever d...

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

100 years of Festo

The spirit of invention is deeply rooted in our corporate culture. Since our foundation, we have been setting benchmarks by developing innovative solutions that...

CSL miljardsatsar på ny behandling inom blodkoagulation

Australiensiska CSL har förvärvat en exklusiv option att köpa nederländska Varmx och dess läkemedelskandidat inom blodkoagulation. Affären kan potentiellt uppgå...