This week we highlight a new diagnostic device for detecting traumatic brain injury and the U.S. Food and Drug Administration’s investigation into the risk of patients developing new cancers after receiving CAR-T cell immunotherapies. We also look at a new generative artificial intelligence biotech startup and a collaboration within the industry to secure renewable energy in manufacturing. Additionally, we explore the approval of Novavax’s updated COVID-19 shot.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
University of Birmingham develops diagnostic device for traumatic brain injury
Researchers at the University of Birmingham have developed an innovative diagnostic device for detecting traumatic brain injury (TBI) using a safe laser for beaming into the eye. Med-Tech News reports that this novel technique, distinct from current diagnostic methods, is expected to evolve into a handheld device crucial for use in the critical first hour after a TBI, when urgent treatment decisions are needed. It offers a fast, precise and non-invasive diagnostic solution suitable for use in various settings like road accidents, battlefields or sports fields. The device works by scanning the optic nerve, which shares biological information with the brain, including protein and lipid biomarkers. Changes in these biomarkers indicate brain health issues making this device a potentially vital tool for early TBI diagnosis and treatment.
FDA investigates ‘serious risk’ of secondary cancer following CAR-T treatment
The FDA is currently investigating the risk of patients developing new cancers after receiving CAR-T cell immunotherapies, a significant concern for these highly efficacious oncology drugs, per FiercePharma. Reports of T-cell malignancies, including CAR-positive lymphoma, have emerged among patients treated with BCMA- or CD19-directed CAR-T therapies, some resulting in hospitalization or death. This potential risk is considered applicable to all approved CAR-T therapies as malignancies have occurred following the use of various products. The FDA is contemplating regulatory actions even though the risk of secondary cancer is already included as a class warning on CAR-T therapy labels. The investigation highlights a new challenge for the CAR-T class, which has transformed care for several blood cancers but now faces the hurdle of balancing efficacy with potential long-term safety concerns.
Generative AI protein design biotech startup raises Series A funding
Stef van Grieken, a former product development leader at Google Brain, has successfully raised $24 million in Series A funding for his biotech startup, Cradle. Axios reports that the startup aims to revolutionize protein design using generative AI, targeting applications ranging from cultured food to vaccines. Cradle’s AI technology is being trained on billions of protein sequences and its own data to assist scientists in innovating and streamlining the often expensive and time-consuming process of protein design.
Pharmaceutical industry collaborates to secure renewable energy in key manufacturing markets
A new collaboration in the pharmaceutical industry aims to decarbonize the global supply chain by focusing on renewable energy in the energy-intensive manufacturing sectors in China and India. Per the European Pharmaceutical Review, this initiative, led by a group of biopharma companies, is in response to these two countries accounting for up to half of the materials used in medicines. This initiative is significant as over half of the health care sector’s emissions are generated in manufacturing supply chains, and energy consumed in these chains accounts for about 25% of total health care emissions. The collaboration is a major step toward reducing the environmental impact of pharmaceutical manufacturing and improving sustainability in the industry.
WHO grants emergency use authorization to Novavax’s updated COVID-19 vaccine
The World Health Organization has granted emergency-use authorization to Novavax’s updated COVID-19 vaccine for individuals ages 12 and older. According to Reuters, this vaccine, which received U.S. authorization last month, is designed to target a descendant of the XBB lineage of the coronavirus. The emergency use listing by WHO is expected to expedite regulatory approvals for importing and administering the vaccine in member states. Novavax, which uses a traditional protein-based technology for its vaccine, had previously faced delays in regulatory approval during the pandemic’s peak, missing the initial vaccine windfall that benefited mRNA vaccine makers.
For more insights in life sciences, check out RSM’s industry outlook.
