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Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)
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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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ZEISS receives FDA clearance for INTRABEAM 700
With its new treatment platform for intraoperative radiotherapy, ZEISS is actively shaping the medical innovation of neuro tumor therapy.
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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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Pharma Outsourcing – Find the Right Partner (2025)
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Licensavtal ska ge Roche nya vägar in i hjärnan
Läkemedelsbolaget Roche ska testa ett nytt sätt att transportera läkemedel till hjärnan – med hjälp av transportmolekyler från Bostonbaserade Manifold Bio.
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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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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 ...
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Danish biotech to buy struggling American oncology company
Danish drugmaker Pharmacosmos has agreed to acquire American pharmaceutical company G1 Therapeutics in a deal that amounts to 405 million dollars.
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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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Vaccine skeptic David Geier to lead study on link to autism
The American government is to launch a study on whether vaccines cause autism – and has appointed a well-known vaccine skeptic to lead the analysis.
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Astra Zeneca’s asthma drug nears approval for sinus inflammation
Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.
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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 ea...
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Nytt samarbete: Chat GPT flyttar in i Lundbecks laboratorier
Den danska läkemedelskoncernen Lundbeck tar hjälp av Open AI för att påskynda forskning och effektivisera arbetet inom hela verksamheten.
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Astra Zeneca pauses multi-million investment in the UK
Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.
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Success for Genmab's antibody-drug conjugate
The Danish company Genmab has received Japanese approval for its treatment for advanced or recurrent cervical cancer.
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Mercodia AB
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New cell therapy raises hope for curing type 1 diabetes – "Never succeeded before"
For the first time, a patient with type 1 diabetes has undergone an islet transplantation using genetically modified insulin-producing cells that do not require...
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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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Samarbete ska ta Tirmed Pharmas eksembehandling in i klinisk fas
Tirmed Pharma ingår ett fördjupat samarbete med Lundbaserade Zelmic om formulering och tillverkning av bolagets läkemedelskandidat för autoimmuna hudsjukdomar.
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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NorthX Biologics Matfors AB
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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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Novartis storsatsar på RNA-terapier – köper miljardbolag
Novartis förvärvar amerikanska Avidity Biosciences för 12 miljarder dollar, motsvarande 113 miljarder kronor. Köpet stärker bolagets position inom sällsynta mus...