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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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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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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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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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New version of ISO 10993-1: the core standard for the biological evaluation of medical devices
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...
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ZEISS showcases expansion of ophthalmic care options creating industry-leading workflow solutions
ZEISS Medical Technology will showcase new ophthalmic innovations and market milestones at ESCRS 2025 in Copenhagen.
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Could an overly burdensome QMS be the organization’s own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...
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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 Söder...
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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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Heart Monitoring in Breast Cancer – Essential or Excessive?
Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...
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Positive trend for Swedish medtech exports – “We have new markets that are huge”
In 2024, Swedish exports of pharmaceuticals decreased for the first time in several years. However, the trend for medical technology looks brighter. During a se...
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ZEISS at EMO Hannover 2025
Experience some of the most exciting highlights from our ZEISS product portfolio.
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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 t...
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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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Explore our tailored program for Control 2025
Choose an innovation tour, or join our industry-specific guided tours.
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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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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 Secretar...
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Björn Arvidsson: ”We must raise our gaze to find the answers of the future”
A system approach isn't just about understanding complexity – it's about making better decisions. By seeing ourselves as part of larger systems, we can better a...
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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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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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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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ZEISS showcases comprehensive workflow for full spectrum of retina care at EURETINA
ZEISS Medical Technology combines its diagnostic, surgical and digital technologies to support healthcare professionals in advancing retinal care.
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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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Anocca raises SEK 440 million ahead of clinical cancer trial
Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.
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