news
FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
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Regulation & Legislation
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EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
video
Short talk: How EN 17141 impacts active air sampler validation
This 11 minutes tutorial highlights the implications of the new EN 17141 for active air sampling compared to the previous standard ISO 14698.
whitepaper
Whitepaper: Progress in LC-MS-based metabolomics techniques
Get updated on recent advances in metabolomics analysis by mass spectrometry (MS) with this introduction to approaches and technologies.
article
How small medical device manufacturers can achieve cost-effective compliant labelling
Susan Gosnell, product manager at NiceLabel, explores the potential labelling compliance issues for small medical device manufacturers and discusses how cloud labelling solutions could help combat them.
news
ICMRA and WHO state clinical trial reports should be published without redaction
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.
news
Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) meeting
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
news
WHO lists Sinopharm’s COVID-19 vaccine for emergency use
The inactivated Vero Cell COVID-19 vaccine is now eligible for global rollout alongside the four other vaccines with World Health Organization Emergency Use Listing.
news
Benlysta approved for adult patients with active lupus nephritis in Europe
The indication of Benlysta (belimumab) was extended after it significantly improved renal outcomes in those with active lupus nephritis.
news
AstraZeneca’s Tagrisso: first medicine approved in the UK under Project Orbis
Tagrisso (osimertinib) was approved for an indication extension after it reduced risk of death by over 80 percent in certain early-stage non-small cell lung cancer patients.
whitepaper
Whitepaper: Analytical testing considerations for ATMPs
This whitepaper discusses the analytical testing considerations for complex biological materials in ATMPs.
whitepaper
Whitepaper: Neutralisers of disinfectants in culture media
A study investigating the efficiency of disinfectant-neutralising agents added to the culture media of contact plates and swabs for surface monitoring.
whitepaper
Web portal: Check your elemental impurity according to ICH Q3D guidelines
Request your Proficiency Testing (PT) samples to ensure your elemental impurity analysis is compliant with ICH Q3D guideline or any other ICP analysis.
news
EC approves Xtandi™ for third prostate cancer indication
Xtandi™ (enzalutamide) was approved for metastatic hormone-sensitive prostate cancer after it reduced the risk of radiographic progression or death by 61 percent in a trial.
article
The UK’s National Security and Investment Bill: a new paradigm for investment, M&A and licensing for life sciences companies
Rebecca Le Flufy, Ross McNaughton and Adrian Toutoungi from Taylor Wessing LLP review the potential impacts of the UK’s National Security and Investment Bill on the life sciences industry and how it could influence future deals.
