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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Hutchison China MediTech Limited announces its unaudited financial results for the six months ended June 30, 2019 and provides updates on key clinical programs.
On July 18, it was reported by Reuters that Canada is opposed to any U.S. plans to buy Canadian prescription drugs because the country fears it will threaten its own drug supply or raise costs for its own people.
Teva Pharmaceuticals, Endo Pharmaceuticals and Taikoku Pharma entered into settlement agreements with the State of California for a total of almost $70 million. The settlements were over non-competitive, inter-company deals that prevented cheaper drugs from entering the market.
Specifically, the civil subpoenas were issued to determine if the company had violated antitrust laws with its rheumatoid arthritis drug Remicade.
There were two issues the agency had. First, the FDA wanted the inclusion of two animal studies to evaluate whether the drug caused thickening of the heart valve. The second was more of a goof—the contract research organization Zogenix employed uploaded the wrong data set for the application.
A recent study conducted by the Milbank Quarterly found that the FDA followed the guidelines of the scientific advisory committees 78% of the time. To come to that conclusion, researchers examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015.
MorphoSys AG will publish its first six months’ 2019 results on August 6, 2019 at 10:00pm CEST.
Galapagos NV announces its unaudited first half-year results, which are further detailed in its H1 2019 report available on the Galapagos website, www.glpg.com.
sterna biologicals selected as one of a group of top-tier European biotech companies to present at the European Biotech Investor Day on August 1, 2019 in New York City
Net sales increased 10 per cent compared to Q2 2018, corresponding to the net of acquisitions and discontinuing operations.