Carving a Path Toward Pragmatic Innovation in Clinical Trials

Prioritizing risk-based management, data science, smart automation, standards, and patient optionality are critical for the industry to keep up with market changes. The recent FDA guidance that encourages ‘pragmatic trials’ in specific scenarios is a move in the right direction. The post Carving a Path Toward Pragmatic Innovation in Clinical Trials appeared first on MedCity…

Read More

AbbVie’s $2.1B Acquisition Adds In Vivo Cell Therapy to Its Immunology & Inflammation Pipeline

AbbVie is acquiring Capstan Therapeutics, a startup with technology that enables in vivo engineering of immune cells. The University of Pennsylvania spinout’s lead program recently began a Phase 1 test as a potential treatment for B cell-mediated autoimmune disorders. The post AbbVie’s $2.1B Acquisition Adds In Vivo Cell Therapy to Its Immunology & Inflammation Pipeline…

Read More

Calculating Social Vulnerability Index by ZIP Code

A paper by Ng, Zhang and Kowal (2025) use the American Community Survey (ACS) data from 2016–2022 were used to construct Social Vulnerability Index (SVI).  SVI is calculated from 16 social determinants of health (SDoH) variables that are grouped into 4 themes: socioeconomic status, household characteristics, racial and ethnic minority status, and housing type &…

Read More

Shifts in Funding Priorities and Vaccine Guidance Contribute to Safety Myths, Plus Reactions to Ruling in U.S. v. Skrmetti — The Monitor

This volume examines how the cancellation of contracts to develop a bird flu vaccine and unfounded claims by new vaccine advisors reflect persistent myths about the safety of mRNA technology. It also explores false claims linking COVID-19 vaccines to miscarriage and analyzes how reactions to a Supreme Court ruling on gender-affirming care for minors highlights…

Read More

Under FDA Clinical Hold, Aardvark Therapeutics Seeks Path Forward for Metabolic Drug

The full FDA clinical hold formally halts all tests of Aardvark Therapeutics’ drug for Prader-Willi syndrome, a rare inherited metabolic disorder that leads to excessive eating. Earlier this year, Aardvark voluntarily paused all tests of its small molecule after a cardiovascular problem emerged in a healthy volunteer. The post Under FDA Clinical Hold, Aardvark Therapeutics…

Read More