Under the radar the FDA has introduced a new regulatory pathway for insulin biosimilars (generic copies of biologic drugs).
“Today is a milestone for the future of insulin and other important treatments – potentially a new era of proposed biosimilar and interchangeable insulin products.”
This will increase competition.
Likely a big issue for the insulin oligopoly Sanofi, Novo Nordisk and Eli Lilly.
Really interesting Interview with the CEO of Drägerwerk, the world leader in the production of ventilators.
On car plants being repurposed to make ventilator components – “There is little point in adapting unused production capacity to manufacture respiratory aids. I spoke with Daimler over the weekend. They would also like to help. But it’s unfortunately not so simple. We can’t build cars either.
Repurposing devices – “There is a lot of potential there... I believe it’s possible to use devices from ambulance service or anaesthesiology departments. Such devices aren’t meant for long-term respiration, but they can serve that purpose.”
The real problem is lack of experts – “It’s not about the device, but about the person who is attached to it. You have to be able to evaluate the person’s state and know how to precisely adjust the device to first save the person’s life and then ensure that they quickly grow healthy again. This requires years of experience.”
Clinicaltrials.gov counts 104 active studies in the US.
There is also SOLIDARITY, a WHO megatrial announced on Friday.
Drugs in Clinical Trials:
Chloroquine (Plaquenil) – 70 year old treatment for malaria repurposed. Only small open label trials done so far (here, here and here) show encouraging early results.
Siltuximab, Sarilumab and Tocilizumab – all IL-6 inhibitors (for anti-inflammatory conditions) repurposed and being clinically tested.
Remdesivir – previously tested for other viruses including Ebola. Two phase III studies initiated.
FDA approves the first portable Magnetic Resonance Imaging (MRI) machine.
“According to Connecticut-based Hyperfine, their machine will cost $50,000, which is 20-times cheaper than traditional systems, runs on 35-times less power and weighs 10 times less than normal 1.5T MRI machines.“
