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Allogene discontinues investigational antibody following patient death
U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pi...
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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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Swedish life science is growing – but capital is not keeping up
The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...
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Novo Nordisk tells staff to return to office
At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...
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Many discontinue obesity medication – new study highlights the reasons
A new study maps out the most common reasons why patients choose to stop taking obesity medication prematurely. “Obesity medication discontinuation reverses hea...
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Vaccine project targeting congenital infection scrapped in late-stage trial – “Clearly disappointed”
Hope for the first vaccine against the world’s most common congenital infection has taken a serious hit
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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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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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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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Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”
Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...
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Ny svängning – Trump hotar med 100-procentiga tullar på läkemedel
USA kommer att införa 100-procentiga tullar på importerade läkemedel, såvida inte bolagen bygger fabriker på amerikansk mark, uppger president Donald Trump.
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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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The scientist behind Novo Nordisk's obesity success: “I never stopped believing in GLP-1”
It took several years of failures in GLP-1 before Lotte Bjerre Knudsen and her colleagues found the right path – but when they did, it was a true breakthrough. ...
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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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Vaccine skeptic David Geier to lead study on link to autism
The American government is to launch a study on whether vaccines cause autism – and has appointed a well-known vaccine skeptic to lead the analysis.
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Trump aviserar ny prispress – läkemedelsjättar faller
USA:s president Donald Trump har återigen riktat fokus mot landets läkemedelspriser. Han presenterar nu två separata initiativ för att pressa priserna på diabet...
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A cluster contribution to European life science innovation and competitiveness?
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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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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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Texas stämmer Tylenol-tillverkare – anklagas för att ha dolt påstådd autismkoppling
Texas justitieminister stämmer Johnson & Johnson och dess avknoppning Kenvue för att ha dolt misstänkta risker med smärtstillande läkemedlet Tylenol, kopplade t...
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Leo Pharma to cut 200 jobs and reorganize
Danish Leo Pharma cuts down on staff in its global operations. Around 200 positions will be cut, while 50 will be moved to Poland.
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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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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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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 –...