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.
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Medtronic plc announced financial results for its fiscal year and fourth quarter 2019, which ended April 26, 2019.
Singapore-based researchers have discovered a possible solution to impede the evolution of bacteria into superbugs that are resistant to drugs and therefore harder to kill.
Researchers from Singapore have designed the world’s first ‘molecular swing’ to transport electrolytes across cell membranes.
“Within this total, the Committee provides target increases for medical product and food safety activities, including new initiatives to revolutionize the safety of the nation’s blood supply and to enable faster responses to foodborne illness outbreaks,” the House Committee said in a statement. “In addition, the bill includes a strong focus on continuing the FDA’s efforts to advance generic drug reviews and increase medical product manufacturing in the U.S.”
Sorilux was approved for the treatment of patients age 12 and up.
FDA Chief of Staff Lauren Silvis indicated the FDA is “pushing forward” with its nonprescription safe use regulatory expansion (NSURE) program, and that “OTC monograph reform remains a top priority for the agency” but “it’s up to Congress to legislate the issue.”
Promore Pharma’s most important task is to develop new products aiming to improve the quality of life for patients with difficult-to-treat wounds and various types of scarring, primarily following surgery.
The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) as the first treatments for transthyretin-meditated amyloidosis.
Auris Medical Holding Ltd. announced that it has received written notification from the Nasdaq Hearings Panel notifying the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550 for continued listing on The Nasdaq Capital Market.
Eisai Co., Ltd. announced today that Eisai has received approval from “Science Based Targets Initiative” for Eisai’s mid and long-term targets for greenhouse gas reduction.