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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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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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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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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 strengthens our concept,” says Medicon Village Innovation CEO Petter Hartman.
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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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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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Lista: Bäst betalda vd:arna inom Big Pharma
Pengar är inte allt, men det skadar inte att få hyggligt betalt för sitt jobb, inte sant? Här är listan över världens bäst betalda vd:ar i inom läkemedelsbranschen.
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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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A new scientific event in Gothenburg
Life Science Sweden is holding an event in Gothenburg for the first time.
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Who pays for Rebecca Doe – and all of us?
Anna Törner on how easily we get used to the idea that healthcare is free - when it really is about how and who pays for it
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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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Investment CEO: “The Nordics are outstanding in creating successful medtech companies”
Since the beginning of last month, Susanna Francke Rodau has been a partner and the new CEO of Segulah Medical Acceleration, which invests in medical technology. In an interview she tells about which companies the investment company prefers to invest in, which companies she believes in the most in the portfolio and why she accepted the new position.
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Life science trends 2025 – Part 1 obesity drugs
More obesity drugs are being launched this year following Novo Nordisk and Eli Lilly's previous successes with GLP-1 drugs. But the next big breakthrough in obesity has a different mechanism of action, writes Samuel Lagercrantz in the first article in a series of trend insights for 2025. Today: obesity.
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Large study on milk: Risky for women but not for men
The risk of ischemic heart disease (IHD) and acute myocardial infarction (MI) increased for women with milk intake levels higher than 2 glasses per day, while no such association was found in men, according to a new large Swedish study.
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Orbán's extended arm becomes health commissioner in the EU
Hungarian Olivér Várhelyi may soon become the most influential official for the healthcare and pharmaceutical industry in the EU. Várhelyi, who is close to Hungarian prime minister Viktor Orbán, is seen as a controversial figure due to his opposition to abortion and for calling EU members ”idiots.”
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USA-besked får Lundabolag att backa på börsen – ”Beslutet från FDA är beklagligt”
Brister hos en kontraktstillverkare riskerar att försena ett eventuellt godkännande av Camurus läkemedelskandidat mot en sällsynt hormonsjukdom i USA. Beskedet fick bolagets aktie att falla på börsen på tisdagen.
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Takeover bid is being completed – Japanese company acquires Calliditas
Japanese company Asahi Kasei completes the bid for Calliditas Therapeutics after reaching over 90 percent of the shareholding. Callidita's board has now decided to apply for delisting of the company´s share from Nasdaq Stockholm.
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Lista: Bäst betalda toppcheferna i läkemedelsvärlden
Det är kul när det går bra för andra, eller hur? Några av dem som det gått riktigt hyggligt för – åtminstone ekonomiskt – listas här på rankningen över de bäst betalda vd:arna inom Big Pharma 2023.
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Innovative start-up helps doctors, scientists and industry balance coagulation risks
in the Netherlands developed an innovative method, the thrombin generation assay (TGA), which provides a complete overview of a physiological process crucial for maintaining normal haemostasis.
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“Life science is important on a personal level”
From the High Coast to the Government Offices. Jeanette Edblad is a native of Ångermanland, and since September last year, she has been Head and Coordinator of the Government’s Life Science Office.
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Ingrid Lönnstedt: Demystification of the power of a scientific study
”You surely do realize that even the smallest changes in study assumptions may influence the estimated sample size needed. And how is it even possible to guess the magnitude of the treatment effect before performing the study?” writes Ingrid Lönnstedt in a column.
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Study: Popular diabetes drug may be effective against liver disease
After its success in diabetes and weight loss, a new potential therapeutic area has been identified for Ozempic and other GLP1 analogues. A new study links the drug type to a reduced risk of liver damage.
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Biogens sparpaket – tusen jobb ska bort
Det är tuffa tider för det amerikanska biotechbolaget Biogen. Nu aviseras kraftiga besparingar och var nionde jobb på företaget väntas försvinna.
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New diagnostic rules raise concerns
In a panel discussion, several voices from academia and the industry expressed concerns about the transition to the new regulatory framework for in-vitro diagnostics (IVDR). They argue that it may create significant differences between regions, and patients may be affected.
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