UK – MSD’s pembrolizumab therapy gets NICE approval

An estimated 1,500 people aged 12 years and over with melanoma are set to benefit from MSD’s –  known as Merck & Co in the...

Europe – CHMP recommends 12 new medicines, including first RSV treatment for infants

The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to...

Europe – Biosimilar medicines can be interchanged

EMA and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference...

Europe – New medicine to protect babies and infants from respiratory syncytial virus (RSV)...

EMA has recommended a marketing authorisation in the European Union (EU) for Beyfortus (nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease...

Europe – EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines

EMA’s human medicines committee (CHMP) has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s vaccine) and Spikevax (Moderna’s vaccine) into standard marketing authorisations....

Europe – Annex 1 implementation strategies: Experts say manufacturers must grapple with PUPSIT

Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to comply with the EU’s GMP Annex 1...

Europe – Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended...

EMA’s human medicines committee (CHMP) has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA launches new conflicts of interest code of practice for independent advisors

The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing a new, single code of practice for all its scientific advisory committees, to ensure...

Europe – COVID-19 vaccines safety update

The safety of authorised COVID-19 vaccines is continuously monitored, and updated information is regularly provided to the public. Safety updates outline the outcomes from assessments...

UK – NICE rejects AstraZeneca and MSD’s Lynparza as NHS prostate cancer treatment

NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an...

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