Drug News 15 to 21 April 2024

European Medicine Agency (EMA) The EMA’s Committee for Medicinal Products for Human Use (CHMP) is scheduled to hold its monthly meeting from April 22 to 25. US Food and Drug Administration (FDA) The FDA made the following decisions: New data from clinical trials (Phase 2, Phase 3) Here are the recent updates on Phase 2 […]

HE Advisory drug news: 25 to 31 March 2024

European Medicine Agency (EMA) Following a positive opinion from the CHMP, the European Commission (EC) has approved Otsuka and Lundbeck’s Abilify Maintena (aripiprazole) as a once-every-two-months long-acting injectable formulation for the maintenance treatment of schizophrenia. Lundbeck press release. The European Medicines Agency (EMA) has granted priority medicines (PRIME) status to 89bio’s pegozafermin for the treatment of […]

Drug News April 01 – 14, 2024

European Medicine Agency (EMA) The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) had their monthly meeting last week. The PRAC found that available evidence does not support a causal association between Glucagon-Like Peptide-1 receptor agonists (GLP-1) – dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide, and suicidal or self-injurious thoughts or actions. See the PRAC meeting highlights. US […]

Drug news 08 January 2024: New data, approvals, safety alerts

Happy New Year! 2023 ended with major events: 1st Crisper therapy approved by regulators: MHRA 1st, FDA and  EMA. Several transactions with significant valuations (e.g. Karuna $14.0 B, Cerevel $8.7 Bn). Let’s see what 2024 will bring to all of us! European Medicine Agency (EMA) The next CHPM meeting is planned on the of week of 22 […]

FDA and EMA activity this week (02 to 08 Dec 2023): drug approvals, positive opinions, safety surveillance and alerts

European Medicine Agency (EMA) This week, the European Medicines Agency (EMA) and the European Commission have approved new drugs for specific indications: ELREXFIO® (elranatamab) by Pfizer: This drug has been approved for the treatment of relapsed and refractory multiple myeloma. ELREXFIO is a bispecific antibody immunotherapy delivered subcutaneously. It targets BCMA on myeloma cells and CD3 […]

InspectIR snags FDA approval, 1st breathing covid test

Earlier this week, the US-FDA announced the issue of an Emergency use authorisation (EUA) for new technology: a breathing covid detector named InspectIR developed by IR Systems LLC. The diagnostic system, looking for specific molecules in the breath, can detect the signature of Covid-19 ongoing infection. The detection of those molecules is performed by gas […]