Europe – Disappointing results from CureVac’s COVID-19 vaccine as phase 2/3 study shows only...

The German biopharma company revealed the lower vaccine efficacy in an interim analysis of data from the pivotal HERALD study in approximately 40,000 participants...

UK – Pfizer/BioNTech, AZ vaccines effective against Delta COVID-19 variant after two doses

The study included 14,019 individuals in England who had tested positive for the Delta variant, of which 166 were hospitalised between 12 April and...

UK – Regeneron’s COVID-19 drug boosts survival in hospitalised patients lacking antibodies

In the UK-based RECOVERY trial, 9,785 hospitalised COVID-19 patients were randomly allocated to receive usual care plus REGEN-COV (casirivimab and imdevimab) or usual care alone. Around one-third of...

International – Let’s mix things up! Innovations in reconstitution technologies

Over the last decade, pharmaceutical and medical device manufacturers have marketed numerous combination products that include lyophilized (i.e., freeze-dried) drugs. (We can define a...

USA – Best practices and education for probiotics amid regulatory uncertainty

Nearly 3 years have passed since the US Food and Drug Administration (FDA) issued its draft guidance for industry on the labeling of probiotic...

USA – FDA approves weight management drug for patients aged 12 and older

The U.S. Food and Drug Administration has approved a supplemental indication for Saxenda (liraglutide) for chronic weight management among pediatric patients aged 12 and...

Europe – Consideration on core requirements for RMPs of COVID-19 vaccines

In addition to the EMA guidance on pharmacovigilance and vaccine development, the EMA issued the “Pharmacovigilance Plan of the EU Regulatory Network for COVID-19...
European Pharmacopoeia revises general chapter on degree of coloration of liquids

Europe – La Commission économique eurasienne et l’EDQM conviennent d’étendre et de renforcer la...

Le 26 mai 2021, la Direction européenne de la qualité du médicament & soins de santé (EDQM) et la Commission économique eurasienne (EEC) ont signé un...

USA – FDA launches global Generic Drug Cluster

In a new effort to boost alignment of scientific and regulatory approaches to generic drug development among global regulators, the US Food and Drug...

International – ICH reports “significant milestones” reached on guidelines ranging from impurity testing to...

The International Council for Harmonisation (ICH) has reported that “significant milestones” were reached over the past year in the adoption of guidelines on residual...

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