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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...

Pharma Outsourcing – Find the Right Partner (2025)

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...

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...

We desire talent to come here, but are we genuinely welcoming them?

Sweden faces significant challenges in creating a truly inclusive environment that makes international professionals feel welcome, valued, and able to build mea...

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...

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 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...

Merck KGaA acquires American company in €3.0 billion deal

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

Aqilion's licensing journey: From Merck partnership to new opportunities

Be extremely meticulous with your scientific data, but spend just as much time and effort on business development. That piece of advice comes from Aqilion's CEO...

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 –...

Getinge and Neobiomics received Swecare's export awards

Two companies received awards during Swecare's annual conference.

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...

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...

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...

Smarta flödesmätare från OEM Automatic

För verksamheter som vill säkra driften och samtidigt förenkla integrationen, erbjuder OEM Automatic nu LABOPLUS och OMNIPLUS från Senseca – två innovativa flöd...

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...

Astra Zeneca’s asthma drug nears approval for sinus inflammation

Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.

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...

Join the premier metrology and quality assurance event of the year

ZEISS QUALITY INNOVATION SUMMIT in Berlin, October 22-24, 2024.

After the threat of tariffs – Novartis invests 230 billion in the USA

Pharmaceutical giant Novartis plans to invest 23 billion dollarsover the next five years to expand its production in the USA. The goal is for all medicines dest...

Novo Nordisk establishes new factory in Denmark

Novo Nordisk establishes a new production facility in Odense, Denmark, an investment of 8.5 billion Danish kroner.

A cluster contribution to European life science innovation and competitiveness?