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Efter förseningen – nu har Ascelia lämnat in sin FDA-ansökan
Efter flera turer och en studie som fick göras om har nu Ascelia Pharma till slut lämnat in en ansökan om marknadsgodkännande i USA för kontrastmedlet Orviglance.
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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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Billion-Dollar Deal Sends BioArctic Soaring
Swedish Alzheimer-focused company BioArctic has entered into a licensing collaboration with Novartis regarding a technology aimed at enhancing efficient drug delivery to the brain. The BioArctic stock surged significantly following the announcement.
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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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Anna Törner: ”Varför inte slå till på en ADHD-diagnos till kampanjpris?”
”Det är självklart positivt att neuropsykiatriska diagnoser inte upplevs som stigmatiserande, men just när det gäller ADHD kan jag inte låta bli att undra om det gått för långt?”, skriver Anna Törner i en krönika om en diagnos som blir allt vanligare.
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Anocca raises SEK 440 million ahead of clinical cancer trial
Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.
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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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The top five most expensive drugs in 2025
New advanced therapeutic medicines are reaching the market, but their price tags remain exceptionally high. This year’s ranking of the most expensive drugs in the US reveals a common denominator: all are gene therapies administered as one-time treatments.
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Alzinova tar steg mot fas II-studie i USA
Biofarmabolaget Alzinova hoppas kunna inleda en fas II-studie med sin vaccinkandidat mot Alzheimers under andra halvåret 2025.
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Allogene discontinues investigational antibody following patient death
U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pivotal CAR-T trial.
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BMS and venture capital giant form new company
The American pharmaceutical company Bristol Myers Squibb, together with the venture capital firm Bain Capital, is forming a new biotech company. The company will develop treatments for autoimmune diseases where there is currently a lack of effective therapies.
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Novo Nordisk appoints Mike Doustdar as new CEO
The Danish pharmaceutical giant Novo Nordisk has appointed Mike Doustdar as its new CEO. At the same time, the company announced it was lowering its forecasts – which caused the stock to drop sharply on Wednesday.
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Positivt USA-besked om Alzecures smärtpreparat
Alzecure har beviljats särläkemedelsstatus i USA för smärtpreparatet ACD440.
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Miljonregn över två svenska biotechbolag – utvalda av EU:s innovationsråd
Pixelgen Technologies och Single Technologies, båda Stockholmsbaserade life science-företag, får finansiering från Europeiska innovationsrådet (EIC) på 12,5 miljoner euro vardera, motsvarande cirka 139 miljoner konor.
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Nytt USA-godkännande för Sobis läkemedel Gamifant
Sobi har fått ett utökat godkännande i USA för sitt läkemedel Gamifant (emapalumab). FDA har nu godkänt behandlingen för vuxna med makrofagaktiverande syndrom (MAS), en allvarlig och potentiellt livshotande komplikation vid Stills sjukdom.
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Novo Nordisk cuts ties with Hims & Hers after Wegovy dispute
Novo Nordisk is ending its collaboration with Hims & Hers Health due to concerns about the company’s sales and marketing practices related to the weight-loss drug Wegovy.
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Lund University’s record-breaking recruitment – attracting researchers from around the world
The Swedish university is launching its largest international recruitment effort ever, aiming to hire 25 researchers globally, including several in the medical field.
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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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Cantargia får snabbspår för antikroppen nadunolimab
Lundabaserade biotechbolaget Cantargia har beviljats Fast Track-status i USA för snabbare utveckling och granskning av sin läkemedelskandidat avsedd för behandling av bukspottkörtelcancer.
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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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US Health Secretary Kennedy dismisses all vaccine experts – assembles new committee
Robert F. Kennedy Jr. has dismissed all 17 members of the CDC’s vaccine advisory panel. A new group of experts will be appointed directly by the Health Secretary, his department announced.
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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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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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Nytt framsteg för Alligators utlicensiering
En antikropp för behandling av magcancer, som licensierats från svenska Alligator Bioscience, har beviljats särläkemedelsstatus i EU.
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