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FDA releases draft guidance for cell and gene therapy industry
The US FDA has published two draft guidance documents, one on gene therapy products and the other CAR T-cell therapies, for developers and manufacturers.
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Regs & Legs
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Video: Upgrade your tablet manufacturing process
Compliant, reliable, safe, and contained conveying of powders and pills in tablet manufacturing replaces manual handling or mechanical conveying.
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New preventative medicine for COVID-19 authorised in UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reported that Evusheld, developed by AstraZeneca, has been granted approval to help protect against the effects of COVID-19.
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Blood pressure tablets recalled due to high levels of nitrosamine
Pfizer is voluntarily recalling Accuretic tablets and two generic high blood pressure treatments, due to levels of nitrosamine above ADI.
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USP Medicine Supply Map to help improve pharma supply chain resilience
Unveiling its Medicine Supply Map, the US Pharmacopeia (USP) showed how reliant the US pharma supply chain is on Indian API manufacturers.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, March 2022
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
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PRIME scheme benefits drug development, finds EMA report
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.
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£260mn in funding to support UK clinical research and medicines manufacturing
The UK Government has committed £200mn to support NHS-led diagnostics and treatment research and £60 million to expand life sciences manufacturing.
![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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FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
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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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UK to support early-stage clinical research with £161 million
New funding for Clinical Research Facilities will boost delivery of first-in-human to early safety and efficacy trials across England.
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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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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…
