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...

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...

Canada approves leqembi as global alzheimer’s drug race heats up

Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...

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...

Lista: Årets mest framstående medicinska uppfinningar

Den subkutana formen av det svenskutvecklade alzheimerläkemedlet Leqembi lyfts fram när Time presenterar sin årliga lista över de bästa uppfinningarna 2025.

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Så går det i kapplöpningen mellan de nya alzheimerläkemedlen Kisunla och Leqembi

Kisunla eller Leqembi? Konkurrensen mellan Eli Lilly och Bioartic fortsätter. Där konkurrenten får godkänt går den andre bet. Här läser du vilka marknader som 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.

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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.

Kennedy attackerar dansk vaccinstudie – ”Propagandanummer från läkemedelsindustrin”

USA:s hälsominister Robert F. Kennedy Jr. uppmanar en medicinsk tidskrift att dra tillbaka publiceringen av en stor vaccinstudie, vars slutsatser han ogillar. M...

Life science trends 2025 – Neurology

New Alzheimer's drugs are beginning to be used in Sweden, more deals in the neuro sector are expected, and tools for deliver active substances across the blood-...

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.

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...

Aqilion's licensing journey: From Merck partnership to new opportunities

Be extremely meticulous with your scientific data, but spend just as much time and effort on business development. That piece of advice comes from Aqilion's CEO...

Pharma Outsourcing – Find the Right Partner (2025)

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...

Eli Lilly Recruits Leading Swedish Researcher Kaj Blennow to Head Alzheimer’s Project

Eli Lilly recruits Kaj Blennow, leading Alzheimer’s researcher, as VP of neuroscience biomarker development.

Strategic Clarity: The New Currency in Life Science

In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, ...

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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...

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...