Policy
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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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Checkpoint Therapeutics announced that its checkpoint inhibitor cosibelimab is showing positive objective response rate data in patients with locally advanced cutaneous squamous cell carcinoma.
Frederick National Laboratories, the American Cancer Society and other leaders are picking up the pieces - both good and bad - as COVID-19 becomes endemic.
Covis announced that the U.S. Food and Drug Administration has granted the company a hearing for its controversial drug Makena, which is intended to reduce preterm births.
An FDA advisory committee voted Wednesday to recommend both the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as six months old.
A recent study found that over a span of ten years, the FDA approved cancer drugs approximately eight months earlier than the same drugs were greenlit by the European Commission (EC).
Jazz Pharmaceuticals, Redx Pharma and Omega Therapeutics are pushing forward with their cancer treatments with Investigational New Drug approval and IND application submission.
Industry lobbyists urge Congress to approve a plan that will allow companies not yet generating revenue from their assets to sell NOL carryforwards to larger companies.
The World Health Organization is giving the monkeypox virus a new name soon in an attempt to quell the stigma and discrimination that might go with it.
Despite geopolitical tensions, the pharmaceutical industry sees China as a land of opportunity and some largely surmountable challenges.
In a unanimous vote, a panel of FDA advisors voted to recommend the approval of Moderna’s COVID-19 vaccine for children between the ages of six and 17 years old.