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Pink Sheet editors discuss the recent departure of a noted vaccine expert and many others from FDA advisory committee rosters, as well as the details and potential impact of the FDA’s release of dozens of complete response letters for unapproved products.

Dutch insulin pump maker ViCentra secured $85m to scale European manufacturing, preparing for the 2026 launch of its thinner, lighter Kaleido 2 pump and push into US market. CEO Tom Arnold said the pump has more than 3,500 users in Europe and expects “tens of thousands” in the next 18 months.

A recent Deloitte survey found that women are emerging as the “chief health officers” of everyday life, younger consumers are something of an enigma, being both adventurous and skeptical, and attitudes to health technologies vary geographically.

Centrient CEO Rex Clements talks about how the industry landscape is shifting for the European pure-play antibiotics producer, addressing issues including supply-chain security, US tariffs, localized manufacturing and AMR, as well as explaining how the firm is incorporating AI into its plans.

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Insights from Novotech on Evolving Trends Impacting Global Clinical Development

The biopharma industry veterans John Maraganore and Clive Meanwell partnered successfully twice before. With Corsera, the co-CEOs have raised more than $50m and aim to predict and prevent cardiovascular disease.

A decade after Teva’s $40.5bn acquisition of Actavis Generics, the deal remains a defining moment for the company. This retrospective explores Teva’s hopes, consequences, leadership shifts, and the firm’s new growth strategy under CEO Richard Francis.

In this week's episode: Lilly’s orforglipron strong in diabetic obesity; Ascletis confident in oral GLP-1 challenger; myostatin drugs progress for obesity; an interview with OneSource’s CEO; and an analysis of Dupixent’s pipeline-in-a-product success.

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.

Minoryx explained to Pink Sheet why it believes its resubmission for leriglitazone stands a stronger chance of approval, and highlighted the value of early dialogue with the regulators when it comes to rare diseases, where the understanding of the natural history and outcomes is often limited.

Academia spinout George Medicines snatched the first FDA approval for a triple combination pill for the initial treatment of hypertension. CEO Mark Mallon highlights the importance of partnering and what is next for the company.