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...

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.

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...

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. ...

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...

Novo Nordisk tells staff to return to office

At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...

Mikael Kubista back with new venture after turbulent exit

Entrepreneur and researcher Mikael Kubista is starting a new company. Now he is also free to comment on the sequence of events that led to him losing ownership ...

A cluster contribution to European life science innovation and competitiveness?

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...

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...

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...

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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...

Enabling 3D Multiplexing Spatial Omics Workflows in Neuroscience

Case study by ZEISS Microscopy.

Oncozenges tablett mot munsmärta utlicensieras för Gulf-regionen

Oncozenge har ingått ett licensavtal med Dubaibaserade Avernus Pharma om kommersialisering i Gulf-regionen av Bupizenge, en sugtablett under utveckling för beha...

Björn Arvidsson: ”We must raise our gaze to find the answers of the future”

A system approach isn't just about understanding complexity – it's about making better decisions. By seeing ourselves as part of larger systems, we can better a...

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...

Merck KGaA acquires American company in €3.0 billion deal

Germany’s Merck is completing the acquisition of Springwork Therapeutics for 3 billion euros.

US Health Secretary Kennedy dismisses all vaccine experts – assembles new committee

Robert F. Kennedy Jr. has dismissed all 17 members of the CDC’s vaccine advisory panel. A new group of experts will be appointed directly by the Health Secretar...

New drug to simplify treatment of hemophilia

A new type of treatment for hemophilia, which only needs to be administered every two months, has been approved by the U.S. Food and Drug Administration (FDA).

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