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.
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The FDA placed a clinical hold on the program due to a determination that there is insufficient information to support dose escalation with the product.
Arguments regarding the Purdue Pharma opioid settlement continue to be heard in court, Natera battles a class-action lawsuit, Walgreens is involved in a public nuisance suit and more.
Public health officials are seeing a notable rise in cases and expressing concerns over more subvariants of the SARS-CoV-2 virus. For those stories and more, continue reading.
The FDA is quickly catching up after COVID-19 disrupted typical review timelines and planned inspections and Monday morning held bad news for Coherus, Junshi and Axsome.
As May gets off to a slow start for the FDA calendar, a few companies have important target action dates.
China’s proposed guidelines for bioethics say that organizations outside of China cannot collect and preserve Chinese human genetic resources inside China or take them out of the country.
Amgen held its earnings conference call on Wednesday for Q1 of 2022. Most notably, the company provided updates on its ongoing litigation with the Internal Revenue Service.
The Q1 results for Voxzogo gave BioMarin the confidence to raise its 2022 full-year guidance to between $100 million to $125 million (net product revenue) for the drug.
Weeks after Gilead Sciences raised concern over counterfeit HIV drugs, Johnson & Johnson has taken similar action against the distribution of counterfeit prescription drugs.
The U.S. Congress is calling for the coronavirus management plan to deliberate on the timeline for the approval and release of vaccines for children under 5 years old.