Policy
Jay Bhattacharya will become the latest leader of the CDC on an acting basis, days after Jim O’Neill stepped aside.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Federal corporate tax cuts that were framed as a way to give a boost to employment across the United States have been more beneficial to companies and shareholders than the average worker or consumer, a new report issued by the advocacy group Americans for Tax Fairness shows.
Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.
According to reports, FDA Commissioner Scott Gottlieb will outline the formation of the Office of Drug Evaluation Sciences, a 52-member group, during his talk at the J.P. Morgan Healthcare Conference in San Francisco later today.
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. Let us know which topics you want to hear more about.
Yesterday, shareholders filed for a class action lawsuit against Tesaro in Delaware federal court, alleging that the merger is based on misleading financial analyses filed with the U.S. Securities and Exchange Commission (SEC).
In theory, the U.S. Food and Drug Administration (FDA) is tasked with overseeing the safety of food and drugs in the U.S. based on science, not politics. That doesn’t always work.
IDE application submitted to the FDA for HEMOSNOWTM
For Adjunctive Treatment of Partial Onset Seizures
A mechanism expected to overcome checkpoint blockade in T cells
Initial results from ongoing Phase 1 study for mesothelin-targeted CAR T support activity and safety in patients with advanced solid tumors