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A cluster contribution to European life science innovation and competitiveness?
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IVDR Reality Check: Are We Moving Fast Enough?
As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...
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GU Ventures AB
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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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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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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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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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LINK Medical Research
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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 health benefits and prompts weight regain in most individuals,” says Hamlet Gasoyan, one...
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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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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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Quality assurance for research and development of medical devices
Overcome the hurdles of research, development, and QA lab environments within the regulated medical technology industry.
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BMS and venture capital giant form new company
The American pharmaceutical company Bristol Myers Squibb, together with the venture capital firm Bain Capital, is forming a new biotech company. The company wil...
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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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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In-Depth Insights into the Most Useful ZEISS Metrology Expert Tips
Free webinar June 24th, 2025, 9:00-9:45 AM and 5:00-5:45 PM.
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Quality solutions for medical device R&D applications
From R&D to the quality assurance of series production in medical device manufacturing.
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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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Sneak Peek of ZEISS Metrology Expert Tips Season 2
The second season of the video series starts in January 2026, but you can discover more about the highlights of Season 2 now.
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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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Wegovy approved in the U.S. for treatment of liver disease
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Novo Nordisk’s drug Wegovy to treat the serious liver condition known as MASH. ...
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Canada approves leqembi as global alzheimer’s drug race heats up
Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...