Week of Jan. 23, 2023

This week we look at an emerging funding source within biotechs, the hottest topics during the recent JP Morgan Healthcare Conference, a revolutionary app to automate insulin dosing, the struggle for Medicare reimbursement of obesity drugs, and the Food and Drug Administration’s final guidance on early-phase cell and gene therapy trials.

Each week we highlight five things affecting the life sciences industry.  Here’s the latest.

Venture debt, loans for companies that have raised money from venture capital firms, is increasing among biotechs. Venture debt doesn’t provide equity to the lender. Because of this, it traditionally sees lower adoption in biotechs due to risks of companies not meeting clinical endpoints and being unable to repay the debt. While other forms of financing struggled during 2022, venture debt maintained a strong presence with over $20 billion lent to biotechs and pharma through the third quarter of 2022.

According to Harris Poll researchers and Endpoints News, gene editing and genomics tied with artificial intelligence and machine learning as the hottest topics during the recent JP Morgan Healthcare Conference (JPM23). Researchers looked at more than 3,150 medical and investment experts’ social media posts from Jan. 2 to Jan.16 to determine the most popular topics.

Tidepool is the first to receive FDA approval to launch its prescription-only app to connect a variety of diabetes management devices and automate insulin dosing. The app is cleared for all Type 1 diabetes patients aged 6 and older. The app allows users to wirelessly manage certain continuous glucose monitors and insulin pumps. The devices which are supported by the app have yet to be announced.

Once found ineffective, obesity drugs are prohibited from being reimbursed under Medicare. A new generation of FDA-approved semaglutide drugs has led to an unexpected alliance between big pharma, the NAACP, a cancer center and a nonpartisan think tank lobbying to overturn the old law. Approximately 42% of Americans over 60 have obesity and changes to the existing law could open treatment to those unable to afford the existing expensive drugs.

This article outlines the FDA’s final guidance on early phase cell and gene therapy trials. During early-phase trials, sponsors desire to collect preliminary evidence of safety using multiple versions of a cellular or gene therapy and they intend to do this within a single “umbrella trial.” It is critical that sponsors plan carefully as they develop the master protocol and make unique considerations for each variant of the product.

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