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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 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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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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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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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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Chiesi satsar på leverinriktad genterapi
Läkemedelsbolaget Chiesi tar ytterligare kliv in på genterapiområdet genom ett licensavtal med amerikanska Arbor Biotechnologies.
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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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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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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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CT technology for when the inside matters
ZEISS METROTOM 1 now at #HandsOnMetrology.
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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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The vaccine has saved 94 million lives – but measles is spreading again
A disease we once believed belonged to the past is now resurging in both Europe and the United States. In the shadow of growing skepticism and declining vaccina...
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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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”The importance of stratification in a statistician’s August kitchen”
Ingrid Lönnstedt writes about an experiment of her own at home and about what lessons can be learned from it, in a science column.
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Quretech granted a European patent for a new type of antibiotic
The European patent provides protection until 2041. Previously, the patent was granted in China, and the application is currently under review in the USA, India, and Japan.
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Trump in new push to lower drug prices
U.S. President Donald Trump announced on Sunday that he plans to sign an executive order to lower the cost of prescription drugs to the same levels paid in othe...
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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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ZEISS Connected Quality: One metrology hub
The new product family ZEISS CONNECTED QUALITY is the solution for quick and secure data exchange, quality management and efficient system monitoring.
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Roche’s Genentech terminates licencing deal with Norwegian biotech
Genentech is ending a license collaboration with Norwegian biotech Nykode Therapeutics regarding a clinical stage cancer vaccine program.
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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 ca...
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Pneumatics Makes a Technological Leap with Piezo
The first high-precision proportional valve terminal VTEP opens up new application areas
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Miljardavtal med Eli Lilly fick Camurus att rusa på börsen
Det svenska forskningsbolaget Camurus har ingått ett licensavtal med läkemedelsjätten Eli Lilly som potentiellt kan ge upp till 870 miljoner dollar, motsvarande...
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The US is leaving the WHO
The newly installed US President, Donald Trump, has issued an executive order for the US to leave the World Health Organization, WHO.
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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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