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Positivt USA-besked om Alzecures smärtpreparat
Alzecure har beviljats särläkemedelsstatus i USA för smärtpreparatet ACD440.
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AZ:s antikroppskonjugat godkänd för ytterligare cancerform
Ett nytt läkemedel mot avancerad icke-småcellig lungcancer har godkänts i USA. Det handlar om Datroway, som tagits fram av AstraZeneca och japanska Daiichi Sankyo.
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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 agreed upon after prolonged negotiations.
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Charged with illegal pharmaceutical sales – alleged earnings of 23 million
For at least five years, two men allegedly carried out illegal sales of pharmaceuticals and supplements, amassing millions. They are now facing charges at Södertörn District Court in Huddinge, south of Stockholm.
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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).
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The race between new alzheimer’s drugs Kisunla and Leqembi heats up
Kisunla or Leqembi? The rivalry between Eli Lilly and Bioarctic is intensifying. Where one drug gains approval, the other falls behind. Here's a look at the markets where these competing treatments are currently available.
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Venomaid's rapid test aims to find the right snake bite treatment
Every six seconds, someone on our planet suffers a snake bite, and each time, a race against the clock begins. What kind of snake was it, and which antivenom can help? Danish company Venomaid Diagnostics is working hard to develop solutions to a problem that claims countless lives, especially in tropical countries.
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Recipharm ingår samarbete med global koncern
Recipharm ingår ett strategiskt samarbete med den globala franska koncernen Product Life Group (PLG).
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Björn Arvidsson: ”Framtiden byggs inte av solospelare”
Björn Arvidsson skriver om vikten av samarbete och tillit mellan hälso- och sjukvården och life science-branschen.
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Rovtidskriftsjägaren om sin ärkefiende: ”Ondskans imperium”
Han myntade begreppet rovtidskrifter och gjorde ett första försök att kartlägga deras utbredning. Nu berättar bibliotekarien Jeffrey Beall om konsekvenserna det fick för honom. Det här är del fyra i Life Science Swedens artikelserie om rovtidskrifter.
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Getinge and Neobiomics received Swecare's export awards
Two companies received awards during Swecare's annual conference.
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Astra Zeneca faces potential multimillion-dollar fines in China
Astra Zeneca could be forced to pay up up to $8 million in fines for allegedly unpaid import duties in China, as the company seeks to rebuild trust following earlier controversies.
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Lundabolag får EU-pengar för stamcellsprojekt
Cellevate har tillsammans med två tyska forskningsaktörer tilldelats en miljon euro av Eurostars-programmet för ett projekt inom storskalig produktion av inducerade pluripotenta stamceller (iPSC).
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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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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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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.