This week we look at the Food and Drug Administration’s approval of an over-the-counter naloxone nasal spray, promising vaccines nearing approval to treat respiratory syncytial virus, and the FDA’s new guidance on diversity considerations for later-stage clinical trials. We also look at a new founder-focused biotech fund that will help entrepreneurs navigate the difficult early stages of a company’s formation. Finally, we review plans for a next-generation biologics plant based in Southern California.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA panel supports over-the-counter sales of naloxone
A panel of FDA experts voted unanimously this week to recommend over-the-counter sales of naloxone, an overdose-reversing drug. The recommendation is non-binding and came despite concerns about confusing packaging and instructions. While there are ongoing studies evaluating the safety of the drug, the panel recommended that the FDA act swiftly to approve over-the-counter sales.
RSV vaccines progressing through trials and may be nearing approval
Respiratory syncytial virus (RSV) is fatal for over 10,000 people per year in the United States. Pharmaceutical companies have researched the virus for years and have been unable to produce a vaccine. However, currently there are 11 RSV vaccines in various stages of clinical trials. Two of these have been submitted to the FDA for approval and it is possible that a decision will be made in the next year.
FDA to require diversity among clinical trial participants
Companies conducting late-stage clinical trials will soon be required to submit a plan detailing diversity considerations for trial participants before receiving FDA approval. Before the requirement taking effect, the FDA will publish draft guidance and allow for a comment period, which could take several years. Diversity in clinical trials has been a topic of discussion in the life sciences industry and the media, of late, as there are concerns that trial populations are not adequately representative of the entire population of potential patients.
New founder-focused biotech fund raises over $500 million
Curie.bio has launched its first fund focused on helping founders launch new therapeutic companies. The fund will provide both seed capital and act as a copilot through the drug discovery process. The team will leverage its experience bringing over 60 drugs into the clinic with 12 approvals to help founders navigate the difficult early stages of a biotech’s formation.
Next-generation biologics plant breaks ground in Southern California
Genentech has unveiled plans for its first facility designed specifically for fast, efficient and sustainable commercial production of biologics for smaller patient populations including rare disease and personalized medicines. Scheduled to be operational by early 2025, the facility will reduce the time needed to transfer production from the clinical to commercial site to days compared to the six to 18 months it currently requires.
