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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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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...
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ZEISS supports the transition of spatial biology to clinical research
Slide scanner ZEISS Axioscan 7 spatial biology provides scalable workflow automation.
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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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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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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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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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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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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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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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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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Novo Nordisk to invest billions in new quality control lab
Novo Nordisk has announced plans to invest 2.9 billion Danish kroner in order to establish a new quality control laboratory in Hillerød in northern Zealand, Denmark.
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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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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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Getinge and Neobiomics received Swecare's export awards
Two companies received awards during Swecare's annual conference.
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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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Speed meets precision for high-density components
ZEISS METROTOM 800 320 kV.
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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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Innovations that drive efficiency.
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Korbinian Löbmann leads scientific meeting on drug formulation: High activity in the field
Korbinian Löbmann has moderated New Updates in Drug Formulation & Bioavailability several times before. Now he is once again taking on the scientific meeting. L...
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The business coach: “We need to learn from our mistakes”
The past year has been challenging for many biotech companies, with several comapanies facing financial stress and bankruptcy. To understand how entrepreneurs c...
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ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment
Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.
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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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