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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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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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Efter bakslaget: GSK:s cancerläkemedel får grönt ljus
Tio nya läkemedel rekommenderas för godkännande i EU, däribland GSK:s cancerläkemedel Blenrep som nu ges en ny chans efter tillbakadragandet från USA-marknaden.
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Venomaid's rapid test aims to find the right snake bite treatment
Every six seconds, someone on our planet suffers a snake bite, and each time, a race against the clock begins. What kind of snake was it, and which antivenom can help? Danish company Venomaid Diagnostics is working hard to develop solutions to a problem that claims countless lives, especially in tropical countries.
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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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The scientist behind Novo Nordisk's obesity success: “I never stopped believing in GLP-1”
It took several years of failures in GLP-1 before Lotte Bjerre Knudsen and her colleagues found the right path – but when they did, it was a true breakthrough. "We invested for 25 years while everyone else laughed at us. Now everyone wants to join the game," says Lotte Bjerre Knudsen, Chief Scientific Advisor at Novo Nordisk.
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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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AstraZeneca´s Trixeo approved in the UK using propellant with near-zero Global Warming Potential
AstraZeneca has received approval in the United Kingdom for its inhaled respiratory medicine Trixeo Aerosphere with a new propellant that is reported to reduce environmental impact by 99.9%.
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Bolag tiodubblade läkemedelpris – döms till miljardböter
En brittisk appellationsdomstol har fastställt en bötessumma på 99 miljoner pund, motsvarande nästan 1,3 miljarder kronor, för ägarna av läkemedelsbolaget Advanz Pharma för att ha tagit ut överpriser för ett viktigt läkemedel.
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Astra Zeneca faces potential multimillion-dollar fines in China
Astra Zeneca could be forced to pay up up to $8 million in fines for allegedly unpaid import duties in China, as the company seeks to rebuild trust following earlier controversies.
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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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Konsultbolag slås ihop – Scandinavian CRO och Qadvis blir Aurevia
Scandinavian CRO och Qadvis har nu bägge officiellt blivit en del av Aurevia, och tar därmed det nya bolagets namn.
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FDA plans to replace animal testing with AI – “Paradigm shift”
The requirement for animal testing in drug development will be phased out and replaced by AI, according to an announcement by the FDA. The decision has been met with skepticism from the National Association for Biomedical Research.
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From pharmacist to life science podcaster – Magnus Lejelöv uses his voice as a tool
Magnus Lejelöv has more than 20 years of experience in the pharmaceutical industry and has conducted nearly two hundred interviews with healthcare professionals on his podcasts.
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Korbinian Löbmann leads scientific meeting on drug formulation: High activity in the field
Korbinian Löbmann has moderated New Updates in Drug Formulation & Bioavailability several times before. Now he is once again taking on the scientific meeting. Life Science Sweden reached out to him.
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Tau-targeted Alzheimer's drug gets Fast Track designation in the USA
Biogen's Alzheimer's candidate BIIB080 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
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Inget statligt stöd för fetmaläkemedel – aktien för läkemedelsjättar pressas
Trump-administrationen slopar Bidens förslag om att om att inkludera fetmaläkemedel i sjukförsäkringen Medicare. Det innebär ett bakslag för Novo Nordisk och Eli Lilly vars aktier pressas.
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Kry i stort ordbråk med regionen – ”Helt dysfunktionell byråkrati”
Nyligen hävde Region Skåne avtalet med Krys barnmorskemottagning i Malmö. På Linkedin slår Kry tillbaka mot kritiken i ett långt och ofiltrerat inlägg, som börjar med ordet ”Suck!”.
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Efter Novo Nordisks hot – Eli Lilly stämmer företag
I förra veckan hotade Novo Nordisk med rättsliga åtgärder mot tillverkare av billiga kopior. Nu stämmer Eli Lilly flera företag som påstår att deras kopior fungerar bättre än originalet.
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New drug to simplify treatment of hemophilia
A new type of treatment for hemophilia, which only needs to be administered every two months, has been approved by the U.S. Food and Drug Administration (FDA).
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