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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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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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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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Billion-Dollar Deal Sends BioArctic Soaring
Swedish Alzheimer-focused company BioArctic has entered into a licensing collaboration with Novartis regarding a technology aimed at enhancing efficient drug de...
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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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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 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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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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De vanligaste frågorna om ånga
Våra ångexperter har gjort en lista över de vanligaste frågorna om ånga och ångsystem. Läs svaren här och spara tid genom att inte behöva söka efter svaren.
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New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”
Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...
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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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Rise and Scantox cease conducting animal testing in Stockholm
Access to in vivo toxicology services is significantly decreasing in the Stockholm area as Rise shuts down animal testing and Scantox reorganizes. ”The costs ar...
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Aqilion's licensing journey: From Merck partnership to new opportunities
Be extremely meticulous with your scientific data, but spend just as much time and effort on business development. That piece of advice comes from Aqilion's CEO...
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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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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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Novo Nordisk appoints Mike Doustdar as new CEO
The Danish pharmaceutical giant Novo Nordisk has appointed Mike Doustdar as its new CEO. At the same time, the company announced it was lowering its forecasts –...
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The top five most expensive drugs in 2025
New advanced therapeutic medicines are reaching the market, but their price tags remain exceptionally high. This year’s ranking of the most expensive drugs in t...
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We desire talent to come here, but are we genuinely welcoming them?
Sweden faces significant challenges in creating a truly inclusive environment that makes international professionals feel welcome, valued, and able to build mea...
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Astra Zeneca’s asthma drug nears approval for sinus inflammation
Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.
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Källor: Novo och Lilly nära prisavtal med Vita huset
Amerikanska läkemedelsbolaget Eli Lilly och danska branschkollegan Novo Nordisk förbereder sig för att tillkännage nya prisavtal för läkemedel i en uppgörelse m...
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Patentutgångar tvingar BMS till nytt sparpaket
Läkemedelsjätten Bristol Myers Squibb planerar nya stora nedskärningar mindre än ett år efter det förra sparpaketet.
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Genmab to Acquire Dutch biotech for USD 8 Billion
Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.
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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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