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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...

Bico säljer bolag inom in vitro-testning och digital patologi

Bioteknikbolaget Bico avyttrar Mattek och Visikol, som integrerades i Mattek operationellt förra året, till Sartorius Lab. Köpeskillingen är på 80 miljoner doll...

Introducing ZEISS arivis Pro 4.2

ZEISS arivis software enhances custom microscopy image analysis.

ZEISS O-INSPECT duo: The multifunctional measuring machine

ZEISS O-INSPECT duo combines advanced microscopy and metrology for impressive measurement accuracy.

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...

Eli Lilly Recruits Leading Swedish Researcher Kaj Blennow to Head Alzheimer’s Project

Eli Lilly recruits Kaj Blennow, leading Alzheimer’s researcher, as VP of neuroscience biomarker development.

Mercodia AB

ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment

Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.

Roche joins Medicon Village

Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...

EMA varnar för icke godkända cellterapier

Icke godkända, och därmed olagliga, avancerade terapiläkemedel marknadsförs till patienter i Europa. Det uppger den europeiska läkemedelsmyndigheten EMA, som nu...

Lilly bygger tablettfabrik i Nederländerna

Efter att ha lanserat flera stora satsningar i USA under året vänder nu Eli Lilly blicken mot EU, och avsätter tre miljarder dollar till en ny tablettfabrik i Nederländerna.

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...

”Din pappas testosteron var högre än ditt – men ingen berättar varför”

Flera studier visar att män i dag har lägre testosteronnivåer än sina fäder – oberoende av ålder, vikt och hälsa. Ändå saknar svensk primärvård tydliga riktlinj...

Scientific Solutions

Sofia Wallström is Lif's new CEO

Sofia Wallström has been appointed as the new CEO of the industry organization Lif, the trade association for the research-based pharmaceutical industry in Sweden.

The new ZEISS Celldiscoverer 7 has been launched

Adaptable automation for advanced workflows.

Anocca raises SEK 440 million ahead of clinical cancer trial

Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.

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...

Snabbtest för halsfluss gav 40 procent falskt positiva svar

Ett snabbtest mot halsfluss har visat sig ge en mycket hög andel falskt positiva svar. Nu uppmanar företaget bakom testet vårdgivare att kassera berörda partier av produkten.

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...

Rekordstor donation till cancerforskning i Lund – ”Once in a lifetime-möjlighet”

Lunds universitet får den största donationen i lärosätets moderna historia, enligt ett pressmeddelande.

Prövning av pillervaccin mot covid-19 avbryts i USA

Det amerikanska hälsodepartementet har beordrat stopp för en statligt finansierad fas IIb-studie som skulle utvärdera ett potentiellt pillervaccin mot covid-19.

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