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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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Positivt USA-besked om Alzecures smärtpreparat
Alzecure har beviljats särläkemedelsstatus i USA för smärtpreparatet ACD440.
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Två patienter dog efter genterapi – företag samlar expertgrupp
Två patienter har avlidit av akut leversvikt efter att ha behandlats med en genterapi för Duchennes muskeldystrofi.
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Virology professor on the threat from X: ”The next pandemic could be worse“
The question is not if, but when we will be affected by a new unknown virus that causes yet another pandemic. Are we sufficiently prepared? "Absolutely not!", responds virologist Niklas Arnberg.
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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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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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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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Pulsen på patientförbunden del 2: Postcovid
Trots att forskningen kring postcovid gjort stora framsteg på senare år är kunskapsluckorna många. Svenska Covidföreningen ser ett akut behov av fler läkemedelsstudier och menar att precisionsmedicin är nyckeln.
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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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Ännu ett Crispr-bolag kraschar
Spotlight Therapeutics, ett amerikanskt genterapibolag, lägger ner verksamheten.
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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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Uppsägningsvåg på Thermo Fisher i USA – hundratals får gå
Flera nedskärningar på kort tid drabbar anställda på Thermo Fisher i USA. Nu får ytterligare 300 anställda gå.
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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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FHM ska leda expertlabb för ebola och okända virussjukdomar
Folkhälsomyndigheten har fått ansvar för att driva det europeiska referenslaboratoriet för smittsamma sjukdomar som ebola, marburg och rabies. Uppdraget omfattar även nya i dag okända virussjukdomar.
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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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Joy at Egetis after positive CHMP opinion – ”The single most important milestone”
Stockholm-based Egetis Therapeutics has received a positive CHMP opinion for Emcitate, which could become the first approved treatment for the rare disease MCT8 deficiency."
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Stor lansering för Cellevate på Bio Europe
Lundabolaget Cellevate tog tillfället i akt under jättekongressen Bio Europe och lanserade sin första industriprodukt kommersiellt.
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Lilly´s Nordic manager on Mounjaro launch in Sweden: "Patients deserve respect"
Another blockbuster diabetes and obesity drug has made its way into the Swedish market – with promises of a stable supply and availability for patients. “What we see is a significant unmet need, so we are expecting to have quite a good welcoming in the market", says Daniel Lucas, Managing Director Nordic Countries at the American pharmaceutical giant Eli Lilly.
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Her company is developing a new tablet form obesity drug
Obesity and diabetes are the primary targets of a new tablet treatment under development by Malmö-based Pila Pharma. The company’s ambition is to take on the billion-selling GLP1 analogues. ‘‘Basically, I expect all the beneficial effects that they have, but not the same side effect profile,’’ company founder Dorte X Gram said in an interview with Life Science Sweden.