Innovation

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

Fusion Pharmaceuticals Inc CEO John Valliant talked to In Vivo about Canadian leadership in radiopharmaceutical innovation, its differentiated approach, and excitement around combination therapies for precision cancer treatments.

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.

Tricuspid valve innovation has taken off since the US FDA’s 2023 authorizations of Edwards' Evoque and Abbott's TriClip systems. Whether to repair or replace tricuspid valves remains an open, nuanced question among cardiologists. Dr. Henrik Treede of University Hospital Mainz and TriCares CEO Ahmed Elmouelhi offer views on the evolving space.

Richard Lowenthal, co-founder and CEO of ARS Pharmaceuticals, highlights the crucial unmet need for needle-free devices to treat type 1 allergic reactions, given challenges associated with current epinephrine injectors. Hear what’s next for the Neffy intranasal spray and ARS Pharmaceuticals.

Bayer adds dry eye treatment to its Bepanthen skin care range; Stada launches special edition Elotrans supplement for Eintracht Frankfurt fans; Hermes offers chewable magnesium supplement; and Klosterfrau introduces Oyono Night extension to help troubled sleepers maintain their immunity.

The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.

The big news in Q3 2024 was the acquisition of Exscientia by Recursion, which has now expanded its pipeline and gained access to more contracts, but this quarter was also marked by numerous seed rounds and M&As, with the strengthening of existing companies and emergence of new ones into what is becoming a crowded space.