“Access to capital increases when there’s an exit”

It remains a tough environment for biotech companies seeking financing – but there is good reason to hope for improvement ahead. That’s the view of Okee William...

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.

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...

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...

Southern Swedish company Aqilion develops drug for eosinophilic esophagitis

When Aqilion began developing a drug for eosinophilic esophagitis, the molecule was classified as an orphan drug. But the prevalence of the disease now appears ...

Shaping regulatory complexity into strategic clarity

As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data A...

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...

A cluster contribution to European life science innovation and competitiveness?

Plug and play dräneringslösningar

En universalkoppling är en anordning som du placerar i din rörledning, och som ger dig friheten att enkelt och snabbt renovera och byta ut ångfällor. Detta mins...

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...

Swedish life science is growing – but capital is not keeping up

The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...

PMS, Vigilance and Risk Management

Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Un...

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...

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

Swedish team tests Alzheimer antibody for brain imaging

Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

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...

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.

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...

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...

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...

ZEISS EVO as the Key to Wire Technology in Modern Medicine

High-performance wires for stents.

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...

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...