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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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Ukraine war fuels rise of totally resistent bacteria
War-torn Ukraine is not just suffering from hostile attacks from a foreign aggressor, but also from the threat of a totally resistant and contagious bacteria.
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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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The business coach: “We need to learn from our mistakes”
The past year has been challenging for many biotech companies, with several comapanies facing financial stress and bankruptcy. To understand how entrepreneurs c...
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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 p...
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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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Carl Zeiss Meditec achieves revenue growth and stable operating profit
Further recovery in order entry compared to prior year.
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Positive EMA Decision for BioArctic's New Drug Candidate
Bioarctic's drug candidate for multiple system atrophy, exidavnemab, is recommended to be classified as an orphan drug, according to the European Medicines Agency (EMA).
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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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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 ...
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How the Foreign Office will promote Swedish life science exports
The broadness and innovative strength keep Swedish life science exports strong, but the protectionist tendencies in the world are worrying, says Camilla Melland...
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FDA’s Top Vaccine Official resigns – Issues sharp criticism of Kennedy
FDA’s Top Vaccine Official is leaving his post while simultaneously criticizing the country’s health secretary for allowing “misinformation and lies” to influen...
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Security flaw in Swedish breast cancer screening software – woman passed away
A lack of safeguard in Sectra's software led to a woman with breast cancer receiving an incorrect diagnosis. She later passed away. The software is used in 20 o...
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New moves around Nykode's management – withdrawal of resignations
Norwegian Nykode Therapeutics is reinstating members of the management team who previously announced their resignations.
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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.
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Who pays for Rebecca Doe – and all of us?
Anna Törner on how easily we get used to the idea that healthcare is free - when it really is about how and who pays for it
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Advanced workflow automation and scalable image analysis in spatial biology
ZEISS and Concept Life Sciences announce partnership.
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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-...
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The art of successful licensing – “A lot has to align”
Sharp research, strong data and a high level of innovation are all very good, but more than that is required to achieve the goal of many biotechnology companies...
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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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ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment
Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.
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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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Large study: The benefits and risks of obesity medications
Medications such as Ozempic can reduce the risk of a range of different diseases and health conditions but also increase the risk of others. This is according t...
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GSK acquires oncology research company
GSK acquires the American biotechnology company Idrx for up to 1.15 billion dollars.
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