This week, we look at the challenges of scaling up monkeypox vaccine production to meet demand as the outbreak continues to grow globally. We also look at a major spin-off of a clinical research organization, over-the-counter hearing aid sales, and one bright spot in the capital markets. Finally, we look at how biotechs are developing novel, and patentable, psychedelic drugs.
Each week we highlight five things to know in the life sciences industry. Here’s the latest.
Monkeypox vaccine manufacturer struggling to keep pace with demand
Bavarian Nordic A/S, a Danish biotechnology company, is currently the only producer of an approved vaccine for the monkeypox virus. The company recently indicated that it may not be able to continue to meet the high demand for the vaccine and is actively seeking partners that could take on parts of the production process. Monkeypox has infected people in over 70 countries and was declared a public health emergency by the World Health Organization in July. To date, the United States has seen the highest number of monkeypox cases and has also received the majority of the vaccine doses.
Labcorp to spin off clinical development business
Labcorp announced this week that it will spin off its clinical development business. The business, which focuses on contract research work, is specifically related to phase 4 clinical trials. This represents a strategic shift from 2021 when the company signaled that such a restructuring was not needed. The clinical research business generated revenue of $3 billion during the year ending June 30, 2022, and management believes there is an opportunity for significant growth in the coming years.
FDA allows over-the-counter hearing aid sales, paving the way for new entrants to the market
The Food and Drug Administration recently created a new category of hearing aids for adults with mild to moderate hearing loss. Such devices will not require a prescription. This development is expected to drive increased competition in the hearing aid market. Large technology and retail companies have expressed interest in entering the sector which could lead to significant reductions in price and additional options for consumers.
Early-stage medtech companies a rare bright spot in capital markets
With many life sciences companies struggling to raise capital in either the public or private markets, early-stage traditional medtech companies appear to be having more success than most raising cash, according to Evaluate Vantage. One interesting wrinkle in this trend is that early-stage financing appears to be going to more traditional companies, while digital health companies are still capturing a large amount of later-stage capital.
Companies explore the medical possibilities of psychedelic drugs, and bring their patent attorneys along on the trip
Some companies, researchers and investors are making big bets on the medical promise of psychedelic drugs for the treatment of mental health disorders. Initial trials were focused on known drugs, such as MDMA and LSD, but even when trials go well, they present a commercial problem. Since the drugs are existing compounds, they are difficult to protect with patents. Now, biotech companies, their chemists and their attorneys are creating new compounds they hope are both more clinically effective and more easily protected by patents.
