EU Commission Launches Next Steps on MDR/IVDR Evaluation, Opens New “Have Your Say”
7 August 2025

The Commission opened a new, yet related, “Have Your Say” initiative: HERE

It reflects the next phase, which is to: Analyse stakeholder feedback (including responses gathered through other channels, e.g., the European Parliament), and outline proposed revisions to better “simplify EU rules for medical devices and in vitro diagnostics” and “ensure availability of safe and innovative devices”. Nothing new is truly known yet. However, the Commission has indicated it intends to share initial proposals by December 2025. Stay tuned; Casus will be monitoring closely.

Oncologists need to see antimicrobial resistance as cancer care delivery crisis.
Yehoda Martei. AMR Action Found 16 Jul 2025.
Learn More at Iinfluence.it.
Menarini Group. July 2025.
Is there an effective alternative to antibiotics?
DW Documentary. 15th Aug 2025

Is there an effective alternative to antibiotics? Researchers around the world are focusing on bacteriophages. These “good” viruses infect specific bacteria and destroy them. Do they offer a way out of the antibiotics crisis? Every year, around 1.3 million people die because of antibiotic resistance. According to the World Health Organization (WHO), this is one of the biggest threats to global health. There are various reasons for the growing number of antibiotic resistances: Unspecific or incorrect use of antibiotics causes bacteria to mutate into multi-resistant germs. In addition, the excessive use of antibiotics in animal husbandry has alarming consequences for humans: Antibiotics, which were considered one of medicine’s greatest achievements against infections, are increasingly losing their effectiveness. Increasingly, science is relying on the potential of bacteria-eating viruses, or bacteriophages, to combat bacteria. Researchers from the US, Georgia, Kenya and Uganda are developing suitable phage therapies and establishing international collaborations. And they’re finding what they’re looking for in bacteria-contaminated wastewater. Phage samples from the US and African countries will help to build up a biobank and produce specific phage cocktails. Phage therapy has not yet been approved in Germany due to a lack of clinical studies. However, in some countries, such as Georgia and Slovakia, bacteriophages are being used successfully to treat patients with antibiotic resistances.

Antibiotic Resistance: Humanity’s Next Big Threat.
Talking with Docs. 27 Aug 2025

In this episode, the speakers are tackling one of the biggest questions in modern medicine: are infectious diseases going to wipe out humanity, or is it just hype? Dr. Paul and Dr. Brad are joined by infectious disease expert Dr. Tom Warren to unpack the truth about antibiotic resistance, superbugs like MRSA, and whether viruses or bacteria pose the greatest threat to our future. We dive into how bacteria become resistant, why antibiotics must be used wisely, and what doctors — and you — can do to help preserve these life-saving medicines. From MRSA to E. coli, from pandemics to prescription habits, this is an honest look at what infectious diseases mean for all of us — and whether we really have a fighting chance.

Achieving Targets from the 2024 UNGA HLM on AMR Political Declaration.
CDC. 8 Aug 2025.

In late September 2024, global leaders met in New York City for the second United Nations General Assembly (UNGA) High-level Meeting (HLM) on Antimicrobial Resistance (AMR). The political declaration from the HLM identified specific commitments and targets for all countries and AMR stakeholders. The webinar featured experts from CDC, Gallup, The Global Fund, and Public Health Authority of Saudi Arabia. During the webinar the panel of experts spoke about: