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The safety and efficacy of fezolinetant is being evaluated in the Phase III trial of over 1,800 women seeking relief from severe vasomotor symptoms associated with menopause (VMS).
The report outlines the positive impact the EMA’s PRIority Medicines (PRIME) scheme has had on drug development for unmet medical need over the last five years.
![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)
New anti-counterfeit technology, called a cyber-physical watermark, leverages edible fluorescent silk to identify medications.
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
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.
1 March 2022 | By
Serious about Making Pharmaceuticals? Attend the UK’s largest event dedicated to supporting the future of the pharmaceutical product life-cycle.
USP is developing mRNA quality guidelines to support the development of innovative medicines and vaccines.
New funding for Clinical Research Facilities will boost delivery of first-in-human to early safety and efficacy trials across England.
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.
Here, Frits Stulp and Duncan van Rijsbergen of Iperion explore how startups can establish the most efficient data management processes and systems, avoiding the kind of mistakes made by Big Pharma.
The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
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…
Here, Dave Elder reflects on the pharma industry’s efforts to get greener; highlighting the confounding issues that mean it is not always easy to achieve.
The EFPIA has published 10 recommendations to ensure that procurement practices across the EU are effective and sustainable, delivering high quality medicines for patients, in the right quantities and at the right time.
A new framework for how the pharmaceutical industry will use health data for research and development of cutting-edge new medicines has opened for consultation.
