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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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Strategic Clarity: The New Currency in Life Science
In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, ...
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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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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Eli Lilly Recruits Leading Swedish Researcher Kaj Blennow to Head Alzheimer’s Project
Eli Lilly recruits Kaj Blennow, leading Alzheimer’s researcher, as VP of neuroscience biomarker development.
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A tiny animal with great importance
From the mythical Ganges River to the less sacred, but considerably cleaner waters in KI's aquariums in Solna. The little zebrafish has made an unconscious care...
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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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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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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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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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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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ZEISS at EMO Hannover 2025
Experience some of the most exciting highlights from our ZEISS product portfolio.
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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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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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ZEISS showcases comprehensive workflow for full spectrum of retina care at EURETINA
ZEISS Medical Technology combines its diagnostic, surgical and digital technologies to support healthcare professionals in advancing retinal care.
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Roche joins Medicon Village
Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...
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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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Explore the possibilities of the new ZEISS METROTOM 800 320 kV
Free ZEISS webinar July 10, 9:00-9:45 AM and 5:00-5:45 PM.
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The art of successful licensing – “A lot has to align”
Sharp research, strong data and a high level of innovation are all very good, but more than that is required to achieve the goal of many biotechnology companies...
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Licensavtal ska ge Roche nya vägar in i hjärnan
Läkemedelsbolaget Roche ska testa ett nytt sätt att transportera läkemedel till hjärnan – med hjälp av transportmolekyler från Bostonbaserade Manifold Bio.
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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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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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Nytt samarbete: Chat GPT flyttar in i Lundbecks laboratorier
Den danska läkemedelskoncernen Lundbeck tar hjälp av Open AI för att påskynda forskning och effektivisera arbetet inom hela verksamheten.
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Anocca raises SEK 440 million ahead of clinical cancer trial
Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.
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