news
New European monograph for Cannabis flower adopted
The European Pharmacopoeia (Ph. Eur.) Commission's new European monograph for Cannabis flower will enter into force in July 2024.
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Regs & Legs
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MHRA authorises new COVID-19 vaccine
The new COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) contains an adjuvant and is indicated to be given to patients over 16 years.
webinar
Analysis of impurities in pharmaceuticals using ion chromatography
2 August 2023 | By Metrohm
This webinar highlights the importance of impurity testing in pharmaceuticals and how ion chromatography can provide excellent sensitivity and selectivity when testing for ionic impurities.
news
New immuno-oncology treatment approved for endometrial cancer
The first new treatment option approved for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer in decades has been authorised by the US Food and Drug Administration (FDA).
news
Innovation passport designation awarded to Pfizer and Arvinas
As the next stage of their co-development of vepdegestrant, the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Pfizer and Arvinas its Innovation Passport to advance development of the oestrogen receptor (ER) degrader for ER+HER2- breast cancer.
news
Paper reports on QbD in bilayer tablet development
A paper has stated that applying the quality by design (QbD) principle during development of bilayer tablets will “help improve product design while also enhancing the quality, safety, and efficacy of drug products”.
news
Approval expanded for generalised myasthenia gravis medicine
Extended EU approval of Soliris to paediatric generalised myasthenia gravis (gMG) patients is based on Phase III data which demonstrated improvement in disease severity through 26 weeks.
news
New CKD treatment option approved in EU
The first SGLT2 inhibitor to demonstrate a statistically significant reduction in all-cause hospitalisations in chronic kidney disease (CKD) patients versus placebo has been approved in the EU.
news
EMA revises guidance on nitrosamine impurities
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
news
Will ESR1-mutated breast cancer treatment gain approval?
If approved by the European Commission (EC), ORSERDU® (elacestrant) would be the first treatment for ER+, HER2- advanced or metastatic breast cancer tumours with ESR1 mutations.
news
EMA seeks public opinion on AI in drug development
Public consultation is open for the European Medicines Agency (EMA)’s draft reflection paper on using artificial intelligence (AI) when developing and regulating medicines.
article
Strengthening and transforming the pharmaceutical supply chain
In this exclusive interview, Naser Al Yammahi, Deputy CEO of Hayat Biotech explores challenges facing the pharmaceutical supply chain, medicine shortages and looks at how technology advances will drive supply chain transformation.
whitepaper
ebook: Key biomarkers of immunomodulation
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
article
The evolution of AAVs in cell and gene therapy
AAV development for cell and gene therapy in 2023 is being impacted by manufacturing and regulation challenges, however advancing technologies offer opportunity, according to leaders in the field.
article
Preparing for stricter standards on substances of human origin
Manufacturers of innovative therapies and other stakeholders handling blood, tissues and cells must prepare for stronger European rules. Ulf Grundmann, Elisabeth Kohoutek and Lara Sophie Hucklenbroich of King & Spalding elaborate on what this means for manufacturers of advanced therapy medicinal products.
