USA – FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention...

Today, the U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of...

International – ICMRA and WHO map out flexibilities used by regulators to respond to...

The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have reviewed some of the practices applied by regulatory authorities worldwide to respond to...

Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November –...

PRAC update on risk of myocarditis and pericarditis with mRNA vaccines EMA’s safety committee (PRAC) has assessed recent data on the known risk of myocarditis...

USA – FDA announces FY 2022 GDUFA science and research priorities

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has announced its science and research priorities for fiscal year (FY) 2022...
MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates

UK – MHRA approves Xevudy (sotrovimab), a COVID-19 treatment found to cut hospitalisation and...

Another COVID-19 treatment, Xevudy (sotrovimab), has today been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be...

Europe – EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)

EMA’s human medicines committee (CHMP) has started a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva. The CHMP’s decision to start the rolling...

Europe – New reports address generics pricing, innovation in the EU

A European generics trade association is calling for relaxation of “extreme cost containment policies” against generic medicines, asserting that such measures are counterproductive and...
Pharmaceutical industry groups and Canadian pharmacists staunchly opposed the US plan to allow states and drug companies to import certain

Europe – EU official says ICH Q6B is outdated and needs revision

The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric...

USA – US regulators set to approve oral antiviral against COVID-19

The group that advises the Food and Drug Administration (FDA) voted to recommend Merck/MSD’s antiviral molnupiravir, which means the treatment could be authorised and...

International – Booster plans expanded to combat Omicron

The UK will now offer all adults a booster jab by the end of January the government has announced. Previously, the scheme was restricted...

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