This week, we look at antimicrobial-resistant diseases, their toll on health systems globally and the need for new treatments. We also feature the continued delays in Food and Drug Administration inspections, the demand for decentralized trials, as well as medtech’s initial public offerings and their subsequent share performance. Finally, we highlight the challenges facing Biogen’s new drug Abduhelm and how it can design clinical trials to address them.
New research has found that deaths from antimicrobial-resistant pathogens exceeded 1.2 million people in 2019, more deaths from malaria or HIV/AIDs. This high volume of cases and deaths puts unneeded stress on health systems in many countries that already struggle to support the needs of their constituents. This shows the need for additional investment and research in treatment options to combat these diseases.
As the omicron variant of COVID-19 continues to ravage the United States and other countries that produce large volumes of pharmaceuticals, the FDA has again delayed restarting non-critical inspections. These delays have impacted new drug approvals. It is not expected that regular inspections will begin until later this spring.
As clinical research organizations and biopharma companies consider what clinical trials will look like after the pandemic, decentralized trials continue to promise additional growth and opportunities to rethink how trials are conducted. In addition to new approaches to trials, new therapeutic technologies like mRNA-based therapies will require rethinking how trials are conducted.
Last year was a complicated one for public offerings for medtech companies. The IPO window was open and 27 companies took advantage of it, but two-thirds of those companies saw their share price fall post IPO. Although deals slowed in the third quarter, there are a number of planned IPOs this year that promise to keep the sector in the sights of public investors.
Medicare last week took an aggressive stance toward paying for Biogen’s Alzheimer’s drug Abduhelm, saying it would reimburse only for patients who are participants in placebo-controlled clinical trials. With that constraint in place, Biogen and other companies pursuing similar treatments are looking at how they would structure those trials. One option, proposed in an article from Endpoints News, is for Biogen to create a very large trial, with broad criteria for participation. This would allow the company to both meet the constraints of Centers for Medicare and Medicaid Services, provide wide access to the new drug, and allow the company to develop enough clinical data to justify revisions to CMS’s decision on reimbursement.
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