Each week we highlight five things affecting the life sciences industry. Here’s the latest.
New inhalation technology aims to expand range of deliverable medicines
- A UK health tech business has secured funding to advance their next-generation inhalation technology which is capable of precisely controlling aerosol droplet size, enabling more efficient delivery of existing medication, reports Bioscience Today.
- Early studies indicate that the new technology can deliver a wider range of treatments, including fragile biologics and advanced therapies, beyond the capabilities of existing inhalation devices, with the potential to improve patient access and reduce healthcare burden.
FDA backs off wearable device enforcement after changes
- The U.S. Food and Drug Administration decided not to take action against a popular wearable technology company’s blood pressure feature after the company revised its labeling and functionality to clearly position it as a general wellness tool (not a medical device), aligning with updated January guidance on low-risk products.
- The outcome highlights how wearable companies can position features as wellness-focused, reducing the likelihood of medical device classification and signaling flexibility in FDA oversight and a favorable environment for consumer health innovation, reports Endpoints News.
Wearable company partners with Big Pharma to support GLP-1 patients
- A large pharmaceutical company partnered with a popular wearable technology company to enable the pharmaceutical company’s platform users on GLP‑1 weight-loss drugs to receive a free ring sizing kit and use the wearable to track physiological changes (e.g., weight, symptoms, biometrics) during treatment.
- According to Endpoints News, the partnership builds on the wearable company’s GLP‑1 tracking program but currently does not include data sharing with the pharmaceutical company, with the goal of helping users better understand and manage their progress independently.
FDA expands pharma company’s product into first-line TNBC settings
- A major pharmaceutical company’s product received approval as a first-line treatment for metastatic triple-negative breast cancer (TNBC), both as a standalone therapy certain for patients and in combination with another drug for other patients, broadening options in an area with historically limited frontline treatments.
- Phase 3 trials showed meaningful improvements in progression-free survival and reduced risk of disease progression/death versus standard care, supporting the combo and monotherapy as potential new standards despite prior setbacks in other indications, reports BioSpace.
HHS moves to strengthen U.S. drug development and clinical trials
- The Department of Health and Human Services is rolling out reforms to speed up early-stage clinical trials and reduce regulatory burden, responding to faster, lower-cost trial starts in China that have attracted biotech companies overseas.
- According to MedtechDive, policy changes target trial efficiency and patient access. Proposed measures include clearer investigational new drug data requirements, flexible trial protocols, rolling FDA feedback and expanded patient enrollment tools (e.g., stipends, telehealth, artificial intelligence) to make U.S.-based trials more competitive and accessible.
For more insights in life sciences, check out RSM’s industry outlook.
