New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”

Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...

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...

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.

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...

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...

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.

Recipharms AI-satsning får stöd från Gates-stiftelse

Svenska Recipharm får utökad finansiering från Bill & Melinda Gates Foundation för att utveckla AI-drivna tillverkningsteknologier. Syftet är att sänka produkti...

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...

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...

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...

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The new Swedish life science strategy – “It will consolidate Sweden as a leader”

Clinical trials and precision health are emphasised as key areas in the new national life science strategy.

FDA plans to replace animal testing with AI – “Paradigm shift”

The requirement for animal testing in drug development will be phased out and replaced by AI, according to an announcement by the FDA. The decision has been met...

Vaccine skeptic David Geier to lead study on link to autism

The American government is to launch a study on whether vaccines cause autism – and has appointed a well-known vaccine skeptic to lead the analysis.

The future of healthcare in focus: ”Together, things happen”

In march, it’s once again time for Fokus Patient, an event for the industry where the patients’ perspective takes center stage. It’s a great way to spread knowl...

The art of successful licensing – “A lot has to align”

Sharp research, strong data and a high level of innovation are all very good, but more than that is required to achieve the goal of many biotechnology companies...

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...

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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...

The scientist behind Novo Nordisk's obesity success: “I never stopped believing in GLP-1”

It took several years of failures in GLP-1 before Lotte Bjerre Knudsen and her colleagues found the right path – but when they did, it was a true breakthrough. ...

Health politician Lina Nordquist: ”I find it hard to be idle”

She is the pharmacist and researcher who grew tired of the breakthroughs that never materialised and knowledge that never seemed to reach patients, so she decid...