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...

Agreement in the EU on eight years of data exclusivity for new medicines

New pharmaceuticals will be covered by eight years of data exclusivity, according to the proposed new pharmaceutical legislation that EU countries have now agre...

Explore our tailored program for Control 2025

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Novokonkurrenten Viking faller på nya fetmadata

Viking Therapeutics redovisar en viktminskning på upp till drygt 12 procent för sitt antifetmapiller under utveckling. Men marknaden hade väntat sig mer, och ak...

ZEISS Smartzoom 100 for Inspection Efficiency

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Nanexa finalist i Fierce Innovation Awards

Uppsalabolaget Nanexa har utsetts till finalist i den internationella tävlingen Fierce Innovation Awards Life Sciences. Bolaget uppmärksammas i kategorin Drug Delivery Technology....

The Top 10 Challenges Facing Laboratories Today

Navigating the Laboratory Automation Landscape

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...

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.

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.

ZEISS continues to drive digital era forward in ophthalmology

2 million digitally planned cataract cases in the U.S. alone.

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.

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...

ZEISS unveils AI-powered Research Data Platform

Collaboration with Boehringer Ingelheim champions the future of personalized eye care.

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...

ZEISS EVO as the Key to Wire Technology in Modern Medicine

High-performance wires for stents.

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...

New version of ISO 10993-1: the core standard for the biological evaluation of medical devices

ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...

J & J fälls efter storgräl om reklambudskap

Att använda förväntade data, byggda på modellering, i läkemedelsreklam kräver extrem tydlighet för att inte vara vilseledande, anser IGN, som fäller Johnson & J...

Non-destructive testing and assembly control

Assess complete assembly.

Novartis storsatsar på RNA-terapier – köper miljardbolag

Novartis förvärvar amerikanska Avidity Biosciences för 12 miljarder dollar, motsvarande 113 miljarder kronor. Köpet stärker bolagets position inom sällsynta mus...

A cluster contribution to European life science innovation and competitiveness?

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.

Discover ZEISS ZEN core – now for electron microscopy

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