USA – FDA issues draft guidance on mpox drug development
In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot...
USA – Pharma groups say ICH guideline on viral safety evaluation needs to incorporate...
US pharmaceutical industry groups endorsed the major principles of the International Council for Harmonization’s (ICH) Q5A(R2) guideline on viral safety of biotechnology products but...
UK – Amvuttra recommended by NICE for amyloidosis
Alnylam has welcomed a draft decision from the National Institute for Health and Care Excellence (NICE) recommending the use of Amvuttra on the NHS...
France – Bronchiolite : Moderna annonce des résultats positifs pour son vaccin
« Le Covid a été un formidable accélérateur pour démontrer la puissance de l’ARN messager, mais nous ne sommes pas qu’une biotech du Covid », confiait...
International – WHO warns on contaminated cough syrups linked to child deaths
This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical...
USA – FDA details approach for finding optimal dosages for new cancer drugs
The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical...
USA – FDA and CDC investigate potential safety concern for Pfizer/BioNTech’s COVID-19 vaccine
The investigation was prompted by preliminary data from the CDC’s vaccine safety monitoring system, which raised a question of whether people aged 65 years...
UK – NICE recommends wider use of statins to cut risk of heart attack...
Up until now, NICE has recommended that those with a 10% or higher risk over ten years of a cardiovascular event should be offered...
USA – Omnibus brings new advanced manufacturing programs to FDA
The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to establish advanced manufacturing...
USA – CERSI Summit: Wider use of real-world evidence continues to face hurdles
The widespread use of real-world evidence (RWE) in regulatory decisions continues to face challenges, including problems with data quality and methodologies, and a disconnect...
