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Leqembi godkänt i EU – ”Vi har väntat väldigt länge”
Bioartics läkemedel Leqembi (lecanemab) mot Alzheimers sjukdom har efter flera turer fått godkänt i EU. Det innebär att det för första gången finns ett godkänt läkemedel i Europa som riktar sig mot den underliggande orsaken till alzheimer.
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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 destined for the US market to be produced within the country.
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FDA plans to replace animal testing with AI – “Paradigm shift”
The requirement for animal testing in drug development will be phased out and replaced by AI, according to an announcement by the FDA. The decision has been met with skepticism from the National Association for Biomedical Research.
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Veteranen inom läkemedelsformulering: Mycket aktivitet i fältet
Korbinian Löbmann har flera gånger tidigare modererat New Updates in Drug Formulation & Bioavailability. Nu tar han åter sig an det vetenskapliga mötet.
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Korbinian Löbmann leads scientific meeting on drug formulation: High activity in the field
Korbinian Löbmann has moderated New Updates in Drug Formulation & Bioavailability several times before. Now he is once again taking on the scientific meeting. Life Science Sweden reached out to him.
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Positive trend for Swedish medtech exports – “We have new markets that are huge”
In 2024, Swedish exports of pharmaceuticals decreased for the first time in several years. However, the trend for medical technology looks brighter. During a seminar, it was discussed how Swedish life science companies can navigate the changing global situation.
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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 går ut med en varning till allmänheten.
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Cellevate stärker ledningen – utnämner CTO
Biotechbolaget Cellevate utnämner Christel Fenge till Chief Technology Officer (CTO).
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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: to succeed with a licensing deal.
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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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Anna Hellergård blir ny vd för Attana
Attana, som arbetar för att effektivisera utvecklingen av nya läkemedel, har utsett Anna Hellergård till ny vd med tillträde 1 april. Det framgår av ett pressmeddelande.
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Security flaw in Swedish breast cancer screening software – woman passed away
A lack of safeguard in Sectra's software led to a woman with breast cancer receiving an incorrect diagnosis. She later passed away. The software is used in 20 out of 21 regions in Sweden. It is also used in neighbouring Nordic countries. “Extremely serious,” says the Sectra CEO to Medtech Magazine.
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Developing rapid diagnostics for sepsis – “Every hour counts”
Finding the right antibiotic in the right dose – with an ultra-fast analysis method. Gradientech's product solution is currently used in routine diagnostics at several hospitals in Europe – and the next target is the US market.
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FDA:s rådgivande vaccinmöte inställt – utan förklaring
Ett årligt möte mellan FDA och deras rådgivande vaccinkommitté ställs in.
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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 preterm born infants.
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Trots ”tyst samordning” mellan läkemedelsbolag – utredning om prissamarbete läggs ned
Konkurrensverket lägger ner utredningen mot flera läkemedelsbolag som misstänktes ha samordnat sin prissättning. Samtidigt anser myndigheten att regelverket öppnar för en ”tyst samordning” som leder till onödigt höga priser.
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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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Sanofi lägger ner projekt inom E. coli-vaccin
Sanofi lägger ner utvecklingen av ett nytt E. coli-vaccin efter ett misslyckande i sen klinisk fas.
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Björn Arvidsson will lead research and innovation in Region Uppsala
The Swedish life science profile Björn Arvidsson has been appointed Director of Research and Innovation for Region Uppsala.
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AI detects tumor disease – via voice recording
A short voice recording along with facial images – both analyzed with an AI algorithm – can make it possible to detect the rare tumour disease acromegaly and initiate treatment at an early stage.
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Marie Gårdmark: “What to expect from Trump’s second term?”
One may complain about the complex multinational system in EU, but it gives us some predictability that cannot be easily overturned by different member states political agendas, writes Marie Gårdmark in a column.
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Här är orden som tvättas bort i Trumps USA
Den amerikanska smittskyddsmyndigheten CDC uppmanar sina forskare att dra tillbaka eller pausa alla nya forskningsstudier som är aktuella för publicering i medicinska eller vetenskapliga tidskrifter. Orsaken är att de först måste ”tvättas” från ord som inte ska användas i Trumps nya USA.
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She is CSL Behring's new Nordic General Manager
Since the beginning of january, Helena Bragd is the new Nordic General Manager for the biotech company CSL Behring and CEO of CSL Behring AB.
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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 can navigate these tough times, Life Science Sweden spoke to Pia Keyser, a business coach at Umeå Biotech Incubator, who has worked with many companies in the industry.
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