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Novartis has received a boost to its arsenal of cancer therapeutics after the FDA approved Pluvicto™ and complementary diagnostic imaging agent Locametz® to treat advanced prostate cancer.
25 March 2022 | By SCIEX
Exploring the complexities of nitrosamines to enhance understanding and overall management, with a focus on nitrosamine drug substance-related impurities (NDSRIs).
The US FDA has published two draft guidance documents, one on gene therapy products and the other CAR T-cell therapies, for developers and manufacturers.
Compliant, reliable, safe, and contained conveying of powders and pills in tablet manufacturing replaces manual handling or mechanical conveying.
Pfizer is voluntarily recalling Accuretic tablets and two generic high blood pressure treatments, due to levels of nitrosamine above ADI.
Unveiling its Medicine Supply Map, the US Pharmacopeia (USP) showed how reliant the US pharma supply chain is on Indian API manufacturers.
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
Despite recent progress in women’s health issues, there are still many challenges women continue to face when accessing healthcare. Here, Alison Slingsby of HRA Pharma discusses the recent advancements made in the UK and where further development is required.
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.
