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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 agre...
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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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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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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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Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)
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ZEISS Lightfield 4D for instant volumetric high-speed imaging
Capturing physiological and neuronal processes in 3D.
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Sneak Peek of ZEISS Metrology Expert Tips Season 2
The second season of the video series starts in January 2026, but you can discover more about the highlights of Season 2 now.
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The Future of Metrology is Coming to Your Region
Join our event series.
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Pharma Outsourcing – Find the Right Partner (2025)
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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 break...
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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. ...
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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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An organ seldom in the spotlight – but utterly vital
The kidneys consist of more than 40 types of cells and have more functions in the body than most people know. Julie Williams leads AstraZeneca’s work in preclin...
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100 years of Festo
The spirit of invention is deeply rooted in our corporate culture. Since our foundation, we have been setting benchmarks by developing innovative solutions that...
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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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GU Ventures AB
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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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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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ZEISS continues to drive digital era forward in ophthalmology
2 million digitally planned cataract cases in the U.S. alone.
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Microscope and measuring machine in one
ZEISS O-INSPECT duo covers two essential applications in quality assurance.
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Large study on milk: Risky for women but not for men
The risk of ischemic heart disease (IHD) and acute myocardial infarction (MI) increased for women with milk intake levels higher than 2 glasses per day, while n...
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Developing rapid diagnostics for sepsis – “Every hour counts”
Finding the right antibiotic in the right dose – with an ultra-fast analysis method. Gradientech's product solution is currently used in routine diagnostics at ...
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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 st...
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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...