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 […]
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 […]
Zombie VCs in Lifescience?
Do you also see increasing VCs having issues with raising funds? Do you agree with this article in the life science funding sphere? Use the following to share your opinion https://survey.zohopublic.eu/zs/coDHby CNBC article: Rise of ‘zombie’ VCs haunts tech investors as plunging valuations hammer the industry
Pharma to fuel biotechs with knowledge, and not only cash
Another sign of the changing environment in the funding of life-science Biotechs: Pharma companies are bringing to partnership deals their knowledge in drug development, and not only cash. Fierce Biotech article
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.
Virtual Reality to help anaesthesia?
On 21 Sept 2022, the BIDMC team published the results of study 1 exploring the impact of pain perception, in a surgery setting, when using anaesthesia versus anaesthesia and a virtual reality immersion. The study was conducted at the Beth Israel Deaconess Medical Center (BIDMC) in 40 participants (34 enrolled) encountering wrist surgery. The main […]