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.

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. ...

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.

Bioscience – Groundbreaking Research & Diagnostics: Gothenburg (2026)

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...

Öresundsinstitutets vd: Novo Nordisk i aktiekris snarare än företagskris

Nedskärningarna på Novo Nordisk väcker frågor i hela den nordiska life science-sektorn. Men enligt Johan Wessman, vd för det dansk-svenska kunskapscentret Öresu...

WuXi AppTec, UK Ltd

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...

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...

New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”

Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...

Danish biotech to buy struggling American oncology company

Danish drugmaker Pharmacosmos has agreed to acquire American pharmaceutical company G1 Therapeutics in a deal that amounts to 405 million dollars.

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LINK Medical recruits Swedish CEO

The Norwegian Contract Research Organization LINK Medical has recruited Anders Göransson as the new CEO.

Unmatched performance and flexibility in its class

The new ZEISS SPECTRUM family is equipped to be the ideal match from measuring small electronics up to larger housings.

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.

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 business coach: “We need to learn from our mistakes”

The past year has been challenging for many biotech companies, with several comapanies facing financial stress and bankruptcy. To understand how entrepreneurs c...

Superconductor technology: Contactless working in the laboratory of the future

Automated filling and weighing of freeze-dry containers in the cleanroom with SupraMotion from Festo

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...

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...

First preterm infants study – a vital step for Neola

After years of developing an advanced lung monitoring system, Neola Medical has received some delightful news: permission to start its first clinical study on p...

Licensavtal ska ge Roche nya vägar in i hjärnan

Läkemedelsbolaget Roche ska testa ett nytt sätt att transportera läkemedel till hjärnan – med hjälp av transportmolekyler från Bostonbaserade Manifold Bio.

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...

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...