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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...
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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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Moderna develops mRNA vaccine against norovirus
A highly anticipated vaccine is in late clinical evaluation and could be ready for approval within a couple of years. The target is the norovirus, often called ...
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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.
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MSD köper Verona Pharma för 10 miljarder dollar
Läkemedelsjätten Merck & Co, känt som MSD utanför USA och Kanada, har ingått avtal om att förvärva Verona Pharma för cirka 10 miljarder dollar, motsvarande cirk...
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Norway rejects national life science strategy – sees no need
The Norwegian Arbeiderpartiet rejects a proposal that Norway should develop its own life science strategy.
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Gene therapy restored hearing in children with congenital deafness
Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...
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Astra Zeneca pauses multi-million investment in the UK
Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.
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Xbrane enters licensing agreement with Indian generics giant
Swedish biosimilar developer Xbrane Biopharma and the Indian company Intas Pharmaceuticals have entered into a license and co-development agreement.
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Vaccine project targeting congenital infection scrapped in late-stage trial – “Clearly disappointed”
Hope for the first vaccine against the world’s most common congenital infection has taken a serious hit
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KI’s freezer fiasco investigated: A chain of failures
A chain of combined technical and organisational shortcomings caused the freezer breakdown at the Karolinska Institute during the Christmas holidays, destroying...
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Medivir CEO on upcoming study: ”It's about working together with others”
are about working together with others," says the company's CEO Jens Lindberg.
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Sneak Peek of ZEISS Metrology Expert Tips Season 2
The second season of the video series starts in January 2026, but you can discover more about the highlights of Season 2 now.
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“Research is always a lot of failures and a few successes”
Gene therapies open up fantastic possibilities, but they are also extremely expensive to produce. Genenova aims to change that and make the treatments accessibl...
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Ny svängning – Trump hotar med 100-procentiga tullar på läkemedel
USA kommer att införa 100-procentiga tullar på importerade läkemedel, såvida inte bolagen bygger fabriker på amerikansk mark, uppger president Donald Trump.
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New cell therapy raises hope for curing type 1 diabetes – "Never succeeded before"
For the first time, a patient with type 1 diabetes has undergone an islet transplantation using genetically modified insulin-producing cells that do not require...
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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.
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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.
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Doge backar om nedläggning av viktigt FDA-labb
Trumpadministrationen drar efter kritik tillbaka beslutet att stänga ett av FDA:s viktigaste laboratorier för läkemedelskontroll.
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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...
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Mercodia AB
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Joy at Egetis after positive CHMP opinion – ”The single most important milestone”
Stockholm-based Egetis Therapeutics has received a positive CHMP opinion for Emcitate, which could become the first approved treatment for the rare disease MCT8 deficiency."
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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...
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FDA approves new cystic fibrosis therapy
A new treatment for cystic fibrosis has been approved by the U.S. Food and Drug Administration (FDA).