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Swedish team tests Alzheimer antibody for brain imaging
Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...
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Thermo Fisher-team flyttar in hos Astra Zeneca Bioventurehub – inleder samarbete
Amerikanska Thermo Fisher och Astra Zeneca Bioventurehub krokar arm i ett nytt FoU-partnerskap. Bolagen ska samlokalisera i Goco Health Innovation City, Göteborg.
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Eli Lilly bygger superdator med techjätte – ska påskynda nya läkemedel
Det amerikanska läkemedelsbolaget Eli Lilly har ingått ett samarbete med techjätten Nvidia för att utveckla en ny AI-superdator som ska påskynda upptäckten och ...
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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 –...
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Could an overly burdensome QMS be the organization’s own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...
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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 Söder...
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FDA’s new CSA guidance: transforming software validation for production and quality systems
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.
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Nanexa finalist i Fierce Innovation Awards
Uppsalabolaget Nanexa har utsetts till finalist i den internationella tävlingen Fierce Innovation Awards Life Sciences. Bolaget uppmärksammas i kategorin Drug D...
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Strategic Clarity: The New Currency in Life Science
In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, ...
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Tre chefsrockader i CTR-koncernen
Forskningskoncernen Center for Translational Research (CTR) genomför flera skiften på ledande positioner. Flera av bolagen inom gruppen får nu nya chefer.
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The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...
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Genmab to Acquire Dutch biotech for USD 8 Billion
Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.
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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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Akademiska först att dosera patient med Affibodys radioterapikandidat
En första patient vid Akademiska sjukhuset har fått behandling med Affibodys målsökande radioterapeutiska kandidat ABY-271 mot HER2-positiv metastaserad bröstca...
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Lonza
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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Alvotech flyttar in i svenskt life sciene-kluster
Isländska Alvotech, noterade på Stockholmsbörsen, flyttar in på Campus Solna. ”Alvotech strävar efter att avsevärt expandera sin forsknings- och utvecklingsverk...
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Recipharm i samarbete om ny ALS-behandling
Recipharm ska samarbeta med israeliska Neurosense Therapeutics om att ta en ny behandling för den neurodegenerativa sjukdomen ALS vidare till fas III-studier.
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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 de...
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Heart Monitoring in Breast Cancer – Essential or Excessive?
Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...
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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...
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Katastrofdoktorn med fokus på resultat: “Allergisk mot ordet välgörenhet“
Det började som en dröm – att få arbeta med Läkare utan gränser. Nu belönas Johan von Schreeb, kirurg och professor i global katastrofmedicin, med Forska Sverig...
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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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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.