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 […]
FDA and EMA activity last week (08 to 14 January 2024): drug approvals, positive opinions, safety surveillance and alerts
European Medicine Agency (EMA) The next CHPM meeting is planned on the of week of 22 Jan 2024.If you are interested about the summary of previous CHMP meetings, send an email to [email protected] with in the title: CHMP, we will take care of it. US Food and Drug Administration (FDA) No new drugs were approved […]
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 […]
Life-Sciences Investment series, October 2022
Health Economia Life-Sciences Investment Series October 2022
Successfully investing in early life science assets, such as medical device projects, diagnostics, digital therapeutics or drug therapies, requires conducting thorough scientific due diligence, monitoring the development plan execution, and implementing a development risk assessment & mitigation plan.
Besides the challenging environment, we observed that this era is appropriate to successfully invest in Life Science assets. After interacting with several Biotech founders, we consistently observed that they need the investors’ advice and network, as much as the funds.
Even in 2020, Serendipity is still of help to Science
A very nice story, hopefully that will end up as a successful vaccine to help the world to handle Covid pandemic. Oxford / AstraZeneca vaccine showed different response rate depending of dosing scheme. In patients who received two full doses, efficacy is evaluated at 62%. In patients who received a half dose and then a […]