![Purdue University biomedical engineers have developed new cyber-physical watermarks that allow people to check medication authenticity with a smartphone [Credit: Purdue University photo/John Underwood].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/cyber-physical-watermarks-2-300x278.jpg)
![Purdue University biomedical engineers have developed new cyber-physical watermarks that allow people to check medication authenticity with a smartphone [Credit: Purdue University photo/John Underwood].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/cyber-physical-watermarks-2-scaled-e1646301472554.jpg)
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Could cyber-physical watermarks be the key to pill-level traceability?
New anti-counterfeit technology, called a cyber-physical watermark, leverages edible fluorescent silk to identify medications.
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Drug Safety
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Clostridioides difficile vaccine shows promise in Phase III trial
Pfizer’s investigational C. difficile vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. difficile infection.
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EDQM remote inspections to become permanent part of inspection scheme
The EDQM will include Real-Time Remote Inspections (RTEMIS) as an integral part of its system for the supervision of manufacturers of active substances from 2022.
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USP calls for industry input in developing mRNA quality guidelines
USP is developing mRNA quality guidelines to support the development of innovative medicines and vaccines.
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EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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β-thalassemia patients achieve transfusion independence with gene therapy
Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
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EU adopts electronic product information standard for medicines
The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
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EU pharmaceutical regulatory outlook for 2022
How will a new regulatory landscape impact the EU and UK pharma industries? Early 2022 will see major new clinical trial legislation come into effect, with proposals for an entirely new regulatory regime promised by the end of the year. Paul Ranson, Consultant at Morgan Lewis, reflects on this and…
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Pharmaceutical analysis with portable spectrometers
Richard Crocombe of Crocombe Spectroscopic Consulting surveys the use of portable spectrometers in pharmaceutical manufacturing, with an emphasis on vibrational spectroscopy. Ideal and typical features of portable spectrometers are reviewed, alongside explanation of why device characteristics and sample presentation are critical to obtaining meaningful results.
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Nexviazyme® improves respiration and mobility long-term in Pompe disease patients
Two-year data shows Pompe disease patients treated with Nexviazyme® (avalglucosidase alfa) have sustained improvements in respiratory function and mobility.
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DARWIN EU® Coordination Centre to integrate real-world evidence into medicines regulation
EMA will establish the DARWIN EU® Coordination Centre to develop and manage a network of real-world healthcare data sources across the EU.
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Phase I oncology studies: rule- versus model-based design
In this article, Karen Ooms, Head of Statistics at Quanticate, compares the rule- and model-based approaches to Phase I trial design, exploring their benefits and weaknesses in defining maximum tolerated dose for oncology products.
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NICE recommends first treatment for children with metachromatic leukodystrophy
The one-time gene therapy treatment for rare, neurodegenerative disease metachromatic leukodystrophy (MLD) is the most expensive drug ever evaluated by NICE.
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Cabenuva HIV treatment approved for eight week dosing
US FDA approves Cabenuva (cabotegravir, rilpivirine) based on results from the ATLAS-2M Phase IIIb trial which showed every-two-month dosing was non-inferior to once-monthly dosing.
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Second COVID-19 vaccine ‘Spikevax’ is approved by the FDA
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
