In Vivo - Strategic Analysis For Medtech And Pharma Leaders since 1981

In this episode of the In Vivo podcast Michelle Werner, CEO of Alltrna, discusses using tRNA as a therapeutic modality for rare diseases.

Israeli-American biotech Immunai is mapping the immune system and using AI to predict immune responses to drugs.

Richard Lowenthal, co-founder, and CEO of ARS Pharma, highlights the crucial unmet need for needle-free injections. Challenging issues posed by current epinephrine injectors, In Vivo questions the current and future progression of Neffy.

Medtech innovators in the APAC region have in recent years seen a slowdown in investment following a combination of rising costs, supply chain challenges and inflationary pressures. But there is light at the end of the tunnel, says MedTech Innovator APAC leader Fredrik Nyberg.

Circular RNA has several advantages, but the field is young. Scandinavian startup Circio Holdings believes its version of the technology will prove the most robust.

AI and machine learning can help companies push failures further up to avoid costly late-stage disappointments.

Overseeing the diverse EMEA region as the regional president of Johnson & Johnson’s Vision business has been a whirlwind of activity for Jacqueline Henderson, in her role since 2023. Fresh back from the ESCRS 2024 meeting, she spoke to In Vivo about how J&J responds to market needs.

As the US biosimilars market approaches the end of its first decade, it has seen another busy year, with Amgen’s surprise launch of a rival to Eylea shaking up expectations as other first-time approvals rolled in throughout 2024. Meanwhile, competition to Stelara is waiting in the wings from the start of 2025.

The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.

Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?

As the pharmaceutical industry readies itself to navigate the complexities of 2025, US pricing trends reveal a landscape shaped by regulatory and legislative changes, innovative pricing models, and the ongoing impact of inflation.

As talks continue on the EU pharmaceutical legislative reform proposals, drug firms may have to wait some time before they find out what the future periods of regulatory data protection and orphan market exclusivity will be.