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Advanced Therapies

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

South Korean Health Ministry Sees Benefits Of Pre-Regulatory Review

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.

Podcast: Acuitas CSO On CRISPR Delivery Breakthrough And Next-Gen Lipid Nanoparticle Technology

In Vivo sits down with Ying Tam, CSO at Acuitas Therapeutics, to discuss the company's role in delivering the first personalized CRISPR treatment to an infant and the clinical implications of new lipid nanoparticle technologies.

Korea Pre-Review Consultations Help Accelerate R&D

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.

Podcast: ADDF’s Karen Harris On Investing In Alzheimer’s Like A VC

A discussion with Karen Harris, CFO of the Alzheimer's Drug Discovery Foundation, about the foundation's investment strategy, biotech and investor sentiment at the recent BIO conference and what innovations give her hope for Alzheimer's patients.

In Conversation With Foundation Fighting Blindness

Jason Menzo, CEO of the Foundation Fighting Blindness, says the organization is adapting its funding strategy, navigating regulatory challenges and accelerating the translation of academic discoveries into industry-led clinical development.

Mapping Biopharma’s AI Strategy: From Custom Datasets to Foundation Models

Biotech companies are pursuing diverse AI strategies beyond expensive custom data generation: foundation model fine-tuning, data-efficient computational methods and targeted proprietary datasets. In Vivo takes a look at some examples.

Brazil Could Look To Germany, UK And Australia For ATMP Drug Pricing Rules

There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.

The Goldilocks Isotope: Perspective Therapeutics’ ‘Just Right’ Alpha Radiotherapeutic

Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.

Podcast: Flagship’s Vision To Predict And Prevent Illness, With Raj Panjabi

Flagship Pioneering senior partner Raj Panjabi discusses shifting health care from reactive treatment to AI-powered prediction and prevention of disease before symptoms emerge.

Deal Build-Up Amid Early ‘Deep’ Response For IGI’s Trispecific In Myeloma

IGI CEO tells Scrip about the “very encouraging” feedback at ASCO to promising early data for the firm's first-in-class investigational trispecific antibody in multiple myeloma. Is a licensing deal in the offing?

UK Bets On Regulatory Innovation As Competitive Advantage In Synthetic Biology

The UK government has prioritized synthetic biology and created a "concierge service" for biotechs just as the US cuts science funding.