5 things to know in life sciences: Week of March 11, 2024 

REAL ECONOMY BLOG | March 15, 2024

Authored by RSM US LLP

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

Public biotech financings on pace for best quarter since 2021

• According to Biopharma Dive, publicly traded biotech companies have raised nearly $10 billion in follow-on stock offerings during the first quarter. The fourth quarter of 2021 is the last time this much follow-on capital has been raised in a single quarter.
• The quarter has also seen a significant uptick in returns for biotech exchange traded funds, as well as an increasing number of initial public offerings.

FDA raises concerns with CAR-T oncology treatments

• The U.S. Food and Drug Administration has expressed concerns about increased rates of early deaths associated with CAR-T therapies in phase 3 trials for multiple myeloma, particularly noting adverse events rather than disease progression as the cause, Fierce Pharma reports.
• While the treatments demonstrate significant benefits in delaying tumor progression, there is a risk of early deaths among patients, which has prompted the FDA to seek input from outside experts on whether the observed negative trend in overall survival is acceptable in light of clinical benefits.

Physicians beginning to explore concurrent radiation and drug-based treatment for breast cancer

• According to MedScape, physicians are exploring the safety of combining targeted treatments, such as antibody-drug conjugates and immunotherapy agents, with radiotherapy in breast cancer.
• There have been limited clinical trials focusing on this approach but immunotherapy with radiotherapy has shown efficacy and has been well tolerated. However, trials of other combinations have yielded mixed results and researchers are hesitant to recommend them until further comprehensive safety and efficacy data are available.

New guidelines from FDA regarding Alzheimer’s treatments

• The FDA has released draft guidelines suggesting that amyloid reduction could serve as a surrogate endpoint for predicting clinical benefit in Alzheimer’s disease treatments amid ongoing debate regarding the link between amyloid reduction and cognitive benefits.
• While the FDA still considers cognitive and functional measures as generally acceptable co-primary endpoints in Alzheimer’s trials, the agency acknowledges challenges in establishing clinically meaningful treatment effects in early-stage disease and is considering alternative approaches, including endpoints based on cognitive assessments or surrogate endpoints, which may allow for shorter trial durations.

AI becoming a major focal point for medtech regulators

• There has been a focus on regulating new technologies that include artificial intelligence.
• MedTech Dive published an interview with Melissa Torres of the Center for Devices and Radiological Health, where she discussed recent AI regulatory discussions by the International Medical Device Regulators Forum, which includes representatives from the European Union, Japan, Canada, Australia, and the U.S., and who regularly collaborate with the World Health Organization.