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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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New findings on the diseases that crushed Napoleon’s army
As if cold, starvation, and typhus weren’t enough. New research reveals that Napoleon’s defeated army also suffered from paratyphoid fever and relapsing fever d...
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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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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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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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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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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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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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Swedish team tests Alzheimer antibody for brain imaging
Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...
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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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Gene therapy restored hearing in children with congenital deafness
Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...
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Getinge and Neobiomics received Swecare's export awards
Two companies received awards during Swecare's annual conference.
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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Merck KGaA acquires American company in €3.0 billion deal
Germany’s Merck is completing the acquisition of Springwork Therapeutics for 3 billion euros.
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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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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 pivotal CAR-T trial....
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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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Phase III win for Hansa Biopharma: “We Are Thrilled”
Swedish biotech Hansa Biopharma’s transplant drug imlifidase has met the primary efficacy endpoint in a registration-enabling Phase III study in the United States.
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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 race between new alzheimer’s drugs Kisunla and Leqembi heats up
Kisunla or Leqembi? The rivalry between Eli Lilly and Bioarctic is intensifying. Where one drug gains approval, the other falls behind. Here's a look at the mar...
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Novo Nordisk cuts ties with Hims & Hers after Wegovy dispute
Novo Nordisk is ending its collaboration with Hims & Hers Health due to concerns about the company’s sales and marketing practices related to the weight-loss drug Wegovy.
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Tiden på väg att löpa ut för Pfizer i budstrid
Pfizers misslyckas med att juridiskt försöka stoppa Novo Nordisks uppköp av bioteknikbolaget Metsera. Den amerikanska läkemedelsjätten har nu två dagar på sig a...
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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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BMS satsar på CAR-T-terapi direkt i kroppen
Läkemedelsjätten Bristol Myers Squibb fyller på sin portfölj inom CAR-T-området genom att förvärva biotechbolaget Orbital Therapeutics för 1,5 miljarder dollar,...
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