This week we look at how energy insecurity and supply chain disruptions are affecting generic drug manufacturers in Europe. We also highlight new treatments for amyotrophic lateral sclerosis (ALS) and Alzheimer’s, as well as the challenges of starting vaccine trials in the midst of an Ebola outbreak. Finally, we look at the challenges of designing placebo-controlled trials for digital therapeutics.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Manufacturers in Europe have long been a key component of the global drug supply chain. Now, a confluence of factors including the war in Ukraine, energy disruptions and cost inflation for raw materials are driving up costs for generic manufacturers that account for 70% of drugs dispensed in Europe. These manufacturers are asking European Union governments to include them in proposed measures to offset rising energy costs.
Patients with ALS will have access to a new treatment option after the Food and Drug Administration approved a drug from Amylx. This is a win for patients and advocacy groups after years of debate on the drugs efficacy.
Alzheimer’s patients have seen rare glimmers of hope this year. First, there was the controversial approval of aducanumab, the first new treatment in years. Now, Biogen and Eisai report promising results from a trial for lecanemab. Similar to aducanumab, this treatment targets amyloid plaques that have long been suspected of causing Alzheimer’s symptoms.
Despite recent successes in developing vaccines for Ebola, the world again finds itself racing to start vaccine trials amid an Ebola outbreak in Uganda. The existing vaccines are effective in treating Zaire ebolavirus, but are not effective in treating the Sudan ebolavirus strain currently spreading in Uganda. Now, three experimental vaccines are rushing to start trials for this rare strain.
Designing placebo-controlled trials can be a challenge, even when the placebo and the drug candidate are indistinguishable from one another. For digital therapeutics, it is not as simple as making a vial of saline or sugar pill. Their challenges in designing trials are much more significant and the impact of the placebo effect should never be underestimated. However, as more of these types of treatments are studied, the industry needs to establish standards that companies can follow in study design.