This week, we look at a new executive order encouraging biomanufacturing, a rare company going public through a special purpose acquisition company and what an executive can do when a trial is placed on a clinical hold. We also look at how progress in curing hepatitis C remains slow despite revolutionary drugs that are available. Finally, Sony gets in the over-the-counter hearing aid business.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Looking back on disruptions to medical supply chains during the pandemic, alongside the growing amount of medical supplies coming from China, President Biden issues an executive order to increase investment in on-shore manufacturing and to promote the development of new drugs. The executive branch hopes to cement the role of the U.S. as a leading innovator even in the face of reduced private investment in the sector.
It has been a rollercoaster ride for SPACs in the past two years. Although the mechanics of SPACs have been around for years, they had quite a resurgence as numerous SPACs were formed and went public in the past two years. After additional scrutiny from regulators, the volume of new SPACs forming and deals taking companies public through a de-SPAC are both down substantially. However, when SPACs are formed they have a short timeline (generally two years) to merge with a private company. So, as Apollomics shows in this article, SPAC deals will likely continue to avoid having to return capital to investors.
No CEO wants to see headlines saying a drug candidate has been placed on a clinical hold. It can mean significant delays, increased costs and a risk that the candidate won’t come off hold to resume the trial. The president and CEO of Immunome shares the story of why the drug candidate was put on hold, what the company did in response and how other biotech leaders should respond in a similar situation.
Developing a cure for hepatitis C was, rightfully, seen as a breakthrough. However, years after the drug’s approval, and despite significant investment by state governments and deals to reduce the high costs of the drugs, progress in helping patient populations with hepatitis C remains elusive. Even after solving for the costs and access to the drugs in Washington and Louisiana, patient advocates and health care providers struggle to get the treatment into the hands of high-risk patient populations that don’t have reliable access to doctors, or a stable environment for treatment.
In August of this year, the Food and Drug Administration issued a new rule allowing over-the-counter sales of hearing aids. Now, Sony has announced a partnership with WS Audiology Denmark to bring self-fitting hearing aids to a store near you. The White House estimates that the new rule allowing over-the-counter sales will save consumers as much as $2,800 per pair and improve access to these devices.