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Alvotech nobbas i USA efter brister i fabrik – dyker på börsen
Isländska Alvotech, noterade på Stockholmsbörsen, har fått ett bakslag i sin lansering av biosimilaren AVT05 i USA, en kandidat som ska motsvara läkemedlet Simponi (golimumab).
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Canada approves leqembi as global alzheimer’s drug race heats up
Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 15 major markets — one more than its closest rival, Eli Lilly’s Kisunla.
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Xbrane backar efter ny FDA-smäll – ”Vi är mycket besvikna”
Xbrane Biopharma backar med över 30 procent på börsen efter fortsatta problem hos en kontraktstillverkare – vilket väntas leda till ytterligare förseningar av en av bolagets biosimilarer i USA.
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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. company now plans to apply for approval of the gene therapy.
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How the Nobel discovery is used in drug development
Regulatory T cells keep the immune system in check, a discovery now awarded the 2025 Nobel Prize in Physiology or Medicine. Qiang Pan Hammarström explains how this finding is being applied in today’s drug development, and what challenges remain.
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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.
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Wegovy approved in the U.S. for treatment of liver disease
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Novo Nordisk’s drug Wegovy to treat the serious liver condition known as MASH. The decision strengthens the company’s position in the field of metabolic diseases.
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Problem hos kontraktstillverkare stoppar Regenerons blodcancerläkemedel
För andra gången har Regeneron nekats godkännande i USA för en ny lymfombehandling. Orsaken uppges denna gång vara anmärkningar mot en extern tillverkningsanläggning, som ägs av Novo Nordisk.
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Positivt USA-besked om Alzecures smärtpreparat
Alzecure har beviljats särläkemedelsstatus i USA för smärtpreparatet ACD440.
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FDA approves Gilead’s HIV injection: “Historic day”
Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally breaking the transmission chain of a virus that affects 1.3 million people annually.
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Icelandic pharmaceutical company Alvotech to list on Nasdaq Stockholm
One of Iceland's largest companies, the pharmaceutical firm Alvotech, has announced its intention to list on Nasdaq Stockholm.
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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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De fick Swecares exportpris
Två företag mottog priser under Swecares årskonferens.
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Eli Lilly requests re-examination of Alzheimer's drug recommendation
Eli Lilly has requested that the EMA re-examine its opinion on the company's Alzheimer's drug, Kisunla, the agency announced on Friday.
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Camurus får grönt ljus i EU för behandling mot akromegali
Lundabolaget Camurus behandling för hormonsjukdomen akromegali – eller jätteväxt – har fått ett positivt utlåtande av den europeiska läkemedelsmyndigheten EMA och rekommenderas för godkännande i EU.
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Mikael Kubista back with new venture after turbulent exit
Entrepreneur and researcher Mikael Kubista is starting a new company. Now he is also free to comment on the sequence of events that led to him losing ownership of his life's work – the company Tataa Biocenter. “Not only did they take our company away from us. They followed up by showering us with lawsuits,” he says.
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Dödsstraff yrkas för mordet på amerikansk vård-vd
Åklagarsidan kommer att yrka på dödsstraff för Luigi Mangione, som står inför rätta för mordet på sjukvårdsförsäkringsbolaget United Healths vd Brian Thompson i New York i fjol.
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Quretech granted a European patent for a new type of antibiotic
The European patent provides protection until 2041. Previously, the patent was granted in China, and the application is currently under review in the USA, India, and Japan.
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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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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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Life science trends 2025 – Neurology
New Alzheimer's drugs are beginning to be used in Sweden, more deals in the neuro sector are expected, and tools for deliver active substances across the blood-brain barrier are being developed. In addition, a new type of drug for MS is making its debut. This part of trend insights on life science 2025 is about neurology.
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The future of healthcare in focus: ”Together, things happen”
In march, it’s once again time for Fokus Patient, an event for the industry where the patients’ perspective takes center stage. It’s a great way to spread knowledge in Sweden and around the world, according to the initiator Penilla Gunther
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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 “food poisoning” or the “stomach bug”.
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Framtidens vård i fokus: ”Tillsammans händer det grejer”
I mars är det återigen dags för Fokus Patient, ett event för branschen där patienternas perspektiv är i fokus. Ett bra sätt att sprida kunskap i Sverige och i världen, enligt initiativtagaren Penilla Gunther.
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