Innovation

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

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.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second

Private Company Edition: ARCH raised more than $3bn for its eighth fund, Frazier added $630m to its public fund that also can back crossover rounds, DCVC’s third biotech fund totaled $400m and Asabys raised €180m ($200m) for its second fund. Also, Aktis closed a $175m series B round.

Christopher Anzalone is spearheading Arrowhead Pharmaceuticals' transformation from a development-focused to a commercial-stage biotech. The CEO touts an “almost plug and play” platform, a derisked development strategy and a busy pipeline with vast potential.

John Lepore, CEO of ProFound Therapeutics and CEO-partner at Flagship Pioneering, discusses the vast possibilities for the human atlas, the benefits of strategic partnering and knowing when to walk away from a project.  

Vitestro's automated blood drawing robot received CE marking on August 28. The company is limiting release of the robot over the next 12 months to a small number of selected hospitals, with plans to scale up production thereafter.

Medtech Insight interviewed Meri Beckwith, co-founder of “anti-CRO” clinical research organization Lindus Health, about his company’s efforts to make clinical trials more efficient and reliable.

In this episode of the Over the Counter podcast, HBW Insight speaks to Kerry's RDA senior manager of immune and joint health, Sonja Nodland, about the opportunity for innovation that postbiotics represent for the consumer health industry. 

The Food and Drug Administration’s final guidance outlines the agency’s thinking for sponsors submitting de novo requests electronically, which they must starting in October 2025.

Brazil looks to EU, UK and others for inspiration on introducing a regulatory sandbox.

BridgeBio spun out oncology assets in May to focus on rare diseases and now it has sliced off a few rare disease candidates for GondolaBio. Also, Avidity and Kymera closed follow-on offerings that grossed $345.1m and $225m, respectively, and Vandria extended its series A round to $30.7m.

Perrigo aims its new SolpaOne high-strength paracetamol effervescent at UK pharmacists, who now have expanded powers as part of the UK government's Pharmacy First initiative. 

Pharmaceutical companies should only use AI in evidence generation and reporting where there is “demonstrable value from doing so,” according to England’s health technology assessment body, NICE.

Plastics – specifically the reduction of virgin plastic in packaging and the move to recyclable or refillable packaging – is one of nine priority topics Kenvue is focused on as part of its global sustainability strategy, according to the company’s global head of packaging innovation, sustainability and experience, David Lickstein.

Meron Mathias is vice president of CSR and sustainability at Thermo Fisher, whose specialty diagnostics division makes it the fifth leading player by revenues in the global IVD industry. In this podcast, she reflects on Thermo Fisher’s early commitment to ESG and sustainability reporting, its Scope 1, 2 and 3 targets and how regulation is moving industry towards a mandatory disclosure landscape.

The MHRA says that having a complete picture of all upcoming filings will allow it to ensure “consistent and predictable” timelines for assessments and identify “potentially transformative technologies” at an early stage.

Keith Murphy, co-founder of Organovo, discusses the growing potential of bioprinting and how the company is using its technologies to study and develop treatments for inflammatory bowel disease (IBD).

As it considers what route to take to independence, Sanofi's Consumer Healthcare business – recently rebranded as Opella – has been changing its approach to marketing, according to chief growth officer Alberto Hernandez. In this exclusive interview, Hernandez explains how “Crazy Elevating Creativity” is delivering real results for Sanofi's top OTC brands.