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NaviFUS begins clinical trial for brain tumour treatment
NaviFUS® was approved by the Taiwan FDA for use in a new clinical trial for the treatment of terminal primary brain tumours.
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Project worth £3.1mn to develop advanced controls for biopharma manufacturing
A collaborative project will develop automated manufacturing controls for biologics such as antibodies, viral vectors and vaccines.
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Microbial air sampler market to value $545mn by 2028
Research suggests the adoption of microbial air samplers to overcome COVID-19, as well as the growth of the pharmaceutical sector will both drive market development.
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What lies ahead in the regulatory pipeline for medical device manufacturers? A compliance strategy to meet the 2023 Class II deadline
Here, Kallik’s Bob Tilling discusses the importance of acting early and embracing technology to comply with EU MDR labelling requirements, citing challenges from the recent scramble by many Class III medical device manufacturers to meet their May 2021 deadline.
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Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
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Lilly to acquire biotech company Protomer Technologies
Eli Lilly and Company has announced the acquisition of California-based biotech company, Protomer Technologies.
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Strengthening the pharma industry’s cyber security defence
Cyber hackers target businesses of all shapes and sizes, but the pharmaceutical industry remains a prime target, especially as these companies undergo digital transformation and move high value data online. But how can the industry protect itself from the threat of cyber attack? Jack Garnsey, Product Manager at VIPRE SafeSend…
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Making the journey to PAT and Pharma 4.0
Here, David Leitham, senior vice president and general manager at AspenTech, explains how implementing PAT pushes the industry towards Pharma 4.0.
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FDA suggests principles for implementing bio-fluorescent particle counters
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
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WHO publishes recommendations on human genome editing
To promote the safe and ethical use of genome editing for the treatment of disease and genetic disorders WHO has published the first global recommendations.
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Long-COVID symptoms improved with neuromodulation
All twenty long-COVID patients who received neuromodulation treatment reported significant improvements in their symptoms in just 14 days.
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Foreign biotech start-up? Uncle Sam wants you! (Despite the challenging funding application process)
Here, FreeMind Group’s Ayal Ronen explains the application process for funding by US Government agencies, exploring the challenges and potential benefits of applying for non-US entities.
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Collaboration to develop neurostimulator for inflammatory disease treatment
neuroloop and Merck will combine their expertise to develop a neurostimulator that can safely and effectively treat chronic inflammatory diseases.
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Using software to improve data management and output in pharma development
The COVID-19 pandemic has exposed various issues with the software and data processes employed in the pharmaceutical industry and spurred rapid digital transformation at a rate never before seen in the sector. In this article, Jordan Stobaugh, Principal Research Scientist at AbbVie, discusses how software can improve data management and…
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Implementing the FAIR data principles is now a critical endeavour
With companies acknowledging the value of their data, it becomes increasingly important that data integrity be assured – and data stewardship implemented. In this article, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance explain the importance of the FAIR (Findable, Accessible, Interoperable, Reusable) data principles, factors…