“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...

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...

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...

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...

Anocca raises SEK 440 million ahead of clinical cancer trial

Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.

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...

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...

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...

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...

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 ...

Agreement in the EU on eight years of data exclusivity for new medicines

New pharmaceuticals will be covered by eight years of data exclusivity, according to the proposed new pharmaceutical legislation that EU countries have now agre...

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...

Heart Monitoring in Breast Cancer – Essential or Excessive?

Papakonstantinou is working to refine how doctors identify which patients truly need intensive follow-up.

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 ...

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. ...

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

Novo Nordisk appoints Mike Doustdar as new CEO

The Danish pharmaceutical giant Novo Nordisk has appointed Mike Doustdar as its new CEO. At the same time, the company announced it was lowering its forecasts –...

Astra Zeneca pauses multi-million investment in the UK

Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.

Positive EMA Decision for BioArctic's New Drug Candidate

Bioarctic's drug candidate for multiple system atrophy, exidavnemab, is recommended to be classified as an orphan drug, according to the European Medicines Agency (EMA).

One System, Three Contrasting Techniques

ZEISS Axioscan 7 clinical - your digital slide scanner for diagnostics and clinical research.

A cluster contribution to European life science innovation and competitiveness?

Acne medication may be the solution when hair starts falling out

A treatment originally developed for acne has shown remarkable Phase III results in a completely different area: male-pattern hair loss.

Cancer researcher: “We can do better and reduce suffering”

Lund University researcher Catharina Hagerling is developing innovative methods to understand metastatic cancer, aiming to create more targeted treatments for p...

ZEISS Quality Innovations at CONTROL

May 6-9, 2025 in Stuttgart.