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.

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).

Study: Popular diabetes treatment is not associated with thyroid cancer

Concerns raised about an association between GLP-1 analogues, used to treat diabetes and obesity, and an increased risk of thyroid cancer are not supported by a...

Setback for pharmaceutical companies in the Zantac case

A Delaware judge has ruled in favour of allowing expert witnesses to testify in a case involving the now-cancelled drug Zantac and its potential carcinogenicity.

AstraZeneca´s Trixeo approved in the UK using propellant with near-zero Global Warming Potential

AstraZeneca has received approval in the United Kingdom for its inhaled respiratory medicine Trixeo Aerosphere with a new propellant that is reported to reduce ...

Bayer has cut 1,500 roles – so far

German chemical and pharmaceutical group Bayer cut more than 1,500 roles in the first quarter alone– and most of them were management positions.

Scientific Solutions

Thumbs down for lecanemab in the EU – “Very surprised”

The Azheimer's drug lecanemab has received a negative assessment from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), acc...

AAX Biotech stärker upp med två nya rekryteringar

I ett led i att stärka sitt innovationsarbete rekryterar AAX Biotech Ionut Gabriel Dumitru till rollen som Senior Scientist och Kushal Sejwal till Business Developer.

“An entire industry is about to be wiped out”

According to Jennie Ekbeck, CEO of Umeå Biotech Incubators, Sweden risks not having any small diagnostic companies left in five years.

Discover ZEISS ZEN core – now for electron microscopy

Watch the recording of our free webinar.

Are you curious about volume imaging for very large samples?

Exciting ZEISS Webinar!

Novo Nordisk sues compounding pharmacies in the US

Novo Nordisk is suing compounding pharmacies in Florida, USA, because the company claims to have found impurities in the active ingredient in the obesity drug Wegovy.

Merck KGaA acquires American company in €3.0 billion deal

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

Konferensen Bioscience fyllde Goco House lokaler

För första gången gick vetenskapskonferensen Bioscience – Groundbreaking Research & Diagnostics av stapeln i Göteborg.

JMP Statistical Discovery

Why the world renown researcher Marc Tessier-Lavigne resigns as Stanford´s president

In mid-summer, neuroscientist Marc Tessier-Lavigne announced his resignation as President of Stanford following allegations of manipulated study data. According...

Kennedy attackerar dansk vaccinstudie – ”Propagandanummer från läkemedelsindustrin”

USA:s hälsominister Robert F. Kennedy Jr. uppmanar en medicinsk tidskrift att dra tillbaka publiceringen av en stor vaccinstudie, vars slutsatser han ogillar. M...

AI-Driven Microscopy Image Analysis in Pharma and Biotech

Extract breakthrough discoveries from large, complex data sets.

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...

Decades of research destroyed at KI – a hacker attack cannot be ruled out!

Years of research, together with half a billion Swedish krona, went up in smoke when the freezers at Karolinska Institutet overheated. The breakdown has now bee...

Beta-blockers are often given unnecessarily, a study finds – “This will affect future practice”

Patients who have suffered a minor heart attack do not benefit from beta-blockers, according to a major new study that may change guidelines for cardiac care.

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...

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