RISE - Research Institutes of Sweden

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...

Genmab to Acquire Dutch biotech for USD 8 Billion

Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.

Virology professor on the threat from X: ”The next pandemic could be worse“

The question is not if, but when we will be affected by a new unknown virus that causes yet another pandemic. Are we sufficiently prepared? "Absolutely not!", r...

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...

Billion-Dollar Deal Sends BioArctic Soaring

Swedish Alzheimer-focused company BioArctic has entered into a licensing collaboration with Novartis regarding a technology aimed at enhancing efficient drug de...

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...

Venomaid's rapid test aims to find the right snake bite treatment

Every six seconds, someone on our planet suffers a snake bite, and each time, a race against the clock begins. What kind of snake was it, and which antivenom ca...

Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)

Multiplex immunofluorescence chemistries with ZEISS tissue multiplexing workflow

Bringing leading multiplex immunofluorescence chemistries together in one automated 8-channel imaging platform.

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. ...

Mercodia AB

ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment

Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.

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.

Pharma Outsourcing – Find the Right Partner (2025)

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...

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.

Allogene discontinues investigational antibody following patient death

U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pi...

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...

BMS and venture capital giant form new company

The American pharmaceutical company Bristol Myers Squibb, together with the venture capital firm Bain Capital, is forming a new biotech company. The company wil...

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...

The top five most expensive drugs in 2025

New advanced therapeutic medicines are reaching the market, but their price tags remain exceptionally high. This year’s ranking of the most expensive drugs in t...

ZEISS showcases comprehensive workflow for full spectrum of retina care at EURETINA

ZEISS Medical Technology combines its diagnostic, surgical and digital technologies to support healthcare professionals in advancing retinal care.

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 –...