Policy
Jim O’Neill was deputy secretary at the Department of Health and Human Services and also acting director of the CDC after the abrupt ouster of Susan Monarez in August 2025.
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
Nearly one year after charges were filed against former Genentech employees accused of stealing trade secrets to benefit JHL Biotech, the two companies have come to an agreement over the ill-gotten intellectual property – destruction.
Global Blood Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) seeking accelerated approval for voxelotor, an oral, once-daily therapy in development for the treatment of sickle cell disease (SCD).
CDC Awarding Opioid Misuse Prevention Grants Directly to Local Health Departments for the First Time
The Centers for Disease Control and Prevention announced the recipients of its Overdose Data to Action grants, including those in 17 local jurisdictions.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission has approved the expanded use of ustekinumab for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
Shares of Mallinckrodt are down more than 45% in premarket trading after multiple reports indicate the company plans a restructuring in the wake of the opioid crisis that has promoted a number of lawsuits that implicate the company for its sales practices in the United States.
Polyphor AG focused on the discovery and development of immuno-oncology compounds and a new class of antibiotics, publishes today its financial results for the first half of 2019 and announces a realignment of the strategy.
$7.2 million total funding since 2015 for more providers of age-friendly healthcare
Recce Pharmaceuticals Ltd announced advances in scaled manufacture and drug quality following positive Food and Drug Administration feedback to its Chemistry, Manufacturing, and Controls data pack.
uniQure N.V. announced that the planned enrollment of 56 patients has been achieved in the HOPE-B pivotal trial of etranacogene dezaparvovec, an investigational AAV5-based gene therapy incorporating the patent-protected FIX-Padua variant for the treatment of patients with severe and moderately severe hemophilia B.
GeneTx Biotherapeutics LLC and Ultragenyx Pharmaceutical Inc. announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation and Rare Pediatric Disease Designation to GTX-102 for the treatment of Angelman Syndrome, a serious, debilitating rare neurogenetic disorder that affects approximately 1 in 15,000 people worldwide.