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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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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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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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Partial court victory for entrepreneur who lost his company
Swedish life science entrepreneur Mikael Kubista has won the first round against a law firm that he, along with other co-owners, sued for negligent advice in co...
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Venomaid's rapid test aims to find the right snake bite treatment
that claims countless lives, especially in tropical countries.
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Novo Nordisk sues compounding pharmacies in the US
Novo Nordisk is suing compounding pharmacies in Florida, USA, because the company claims to have found impurities in the active ingredient in the obesity drug Wegovy.
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GSK pays 2.2 billion dollars to settle Zantac lawsuits
British drugmaker Glaxo Smith Kline, GSK, has struck a 2.2 billion dollar settlement, thereby resolving a vast majority of the liability cases pending against t...
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Astra Zeneca's Covid-19 vaccine Vaxzevria is being withdrawn worldwide
AstraZeneca initiates a worldwide withdrawal of its Covid vaccine Vaxzevria. The measure is taken just months after the company admitted the vaccine can cause a...
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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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Setback for pharmaceutical companies in the Zantac case
A Delaware judge has ruled in favour of allowing expert witnesses to testify in a case involving the now-cancelled drug Zantac and its potential carcinogenicity.
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Ingrid Lönnstedt: What does the p-value mean?
The smaller the better, and preferably smaller than 0.05. A p-value smaller than 5% means that the treatment effect is statistically significant at 5% significa...
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Hypothesis testing versus conspiracy theory
"How do you know what is a conspiracy theory and what is a reasonable, scientifically based conclusion?" In a column, Ingrid Lönnstedt reflects on this question.
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A new life science cluster formed – “We are very strong in talent”
Stockholm and Uppsala’s joint life science cluster aims to be among the best in Europe. Pontus Holm, Life Science Coordinator for Region Stockholm, says the dec...
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Settlement of cancer allegations against blockbuster drug
French pharmaceutical company Sanofi has reached a principal agreement in the US on around 4,000 of the cases in which its now withdrawn blockbuster heartburn d...
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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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Decades of research destroyed at KI – a hacker attack cannot be ruled out!
Years of research, together with half a billion Swedish krona, went up in smoke when the freezers at Karolinska Institutet overheated. The breakdown has now bee...
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Suing the company – for NOT developing a new HIV drug
Was Gilead putting a steady flow of profits from its cash cow ahead of developing a new and safer drug? According to a large number of US HIV patients in a lega...
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Webinar: Medtech quality and regulatory compliance
This webinar is for you who are developing or planning to develop a medical device, combination, or borderline product. In one hour, we will discuss what you ne...
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”Information security must become part of the Swedish life science strategy”
Sweden needs knowledge security to stand strong in the global competition, writes Björn Ursing in an opinion article.
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Claims of life science companies fleeing abroad is a myth according to survey
The claim that life science companies are moving abroad is exaggerated. In fact, only a tiny percentage is leaving the country, according to a survey.
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To build trust, one must be able to say “I don’t know” – whether human or AI
Will AI strengthen or break down trust? It depends on whether we can understand and accept its limitations, and our own, writes Sarah Lidé in a column.
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Uppsala-based company wins important patent dispute – but the decision is subject to appeal
A US district court has ruled in favour of Orexo in a dispute over the patent protecting the Swedish company’s drug Zubsolv, developed for treating patients wit...
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Rapid development in blood analysis – “Sweden is leading the race”
Thousands of analytical tests using just one single drop of blood. What was revealed as a hoax just a few years ago is now a reality, according to KTH professor...
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The Oresund region aims at becoming Europe’s microbiome Mecca
The Medicon Valley Alliance’s ambition: Skåne and the Copenhagen region will become world leaders in microbiome research.
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