Week of June 12, 2023

This week we’re tracking new COVID-19 booster strategies targeting the XBB variant, Moderna’s move into mRNA therapies for rare diseases, U. S. Food and Drug Administration guidelines to safeguard tattoo inks, challenges for European medical device startups, and a Scottish startup’s pilot telerobot enhancing nursing care.

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

Despite dwindling demand for COVID-19 vaccines, health care officials are working on ensuring the availability of the most effective shots. The FDA’s advisory committee is considering focusing on a single XBB variant for the fall booster campaign, marking a shift from the previous bivalent boosters. The XBB variant, a development from the omicron strain, is responsible for most of the COVID-19 cases in the United States. Manufacturers are already developing vaccines targeting the XBB.1.5 subvariant, even as vaccine revenues have declined with Pfizer and Moderna predicting significant sales drops.

Moderna, known for its development of a COVID-19 vaccine, is transitioning its focus to the treatment of rare diseases using its mRNA technology. Early results indicate that mRNA may aid in producing necessary enzymes in children with specific metabolic diseases, potentially decreasing metabolic crises by approximately 66%. The shift in focus represents a strategic evolution for Moderna, which was previously questioned over the viability of its mRNA technology. With roughly $16.4 billion in resources, the company is planning to expand its exploration of rare disease treatments that could mimic its extensive vaccine development pathway. The goal is to leverage mRNA technology to provide the genetic code for missing or broken proteins in people with genetic conditions. Despite these early findings, there are still concerns related to the safety and tolerability of chronic mRNA therapy, especially regarding side effects. However, it’s noteworthy that all the patients in the completed study chose to continue the treatment. Moderna is developing multiple therapies and expects to advance more to clinical trials in the coming years.

The FDA has released draft guidelines to help tattoo ink manufacturers and distributors prevent microbial contamination in their products. This follows several reports of illnesses caused by contaminated inks, with numerous sealed tattoo inks found to have microbial contamination. The guidelines recommend testing for microbial contamination in both ink components and finished products, ensuring manufacturing processes are clean and sanitary, and validating sterilization methods. The FDA is encouraging public reporting of adverse reactions from tattoos through its MedWatch program. The agency is now seeking comments on the draft guidelines within 90 days of publication.

Delays in obtaining Conformité Européenne certification for medical devices in Europe are causing significant challenges for startups pushing them to turn their attention to the U.S. market. The European Council has extended deadlines for existing devices to remain on the market, but startups face lengthy waiting times for certification, hindering investor attraction and product launch. Concerns arise about the disadvantage European startups face compared to international competitors that benefit from easier certification processes in their home markets. Some startups are considering launching in markets with streamlined certification or finding ways to avoid engaging with the medical device regulation. They call for a more transparent, standardized and accelerated validation process, along with increased support. The European Commission has initiated projects to address these issues, including training and matchmaking portals for companies and notified bodies.

A telerobot developed by Scottish deep-tech startup Touchlabs has been launched at Laakso Hospital in Finland for a three-month pilot scheme aimed at enhancing nursing care and reducing workloads. Named Välkky, the robot uses electronic skin technology to transmit tactile sensations enabling nurses to measure vital signs such as pulse, temperature and oxygen saturation. In addition to vital sign measurement, Välkky is designed to perform tasks like handling patient meals, moving medical devices and even brushing hair. The robot’s deployment addresses the need for innovations in nursing care robotics, especially in light of aging populations and staff shortages. Touchlabs aims to demonstrate the coexistence and support of semi-autonomous robots with health care professionals and other industries, gathering anonymized real-time data during the project to validate these capabilities.



Source link: https://realeconomy.rsmus.com/5-things-to-know-in-life-sciences-week-of-june-12-2023/ by Justin Culbertson at realeconomy.rsmus.com