Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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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Recipharm AB, through its directly wholly-owned subsidiary Recipharm Holdings Limited, published an offer document setting out the full terms and conditions of its recommended cash offer to acquire the entire issued and to be issued share capital of Consort Medical plc .
As the J.P. Morgan Healthcare Conference winds down for 2020, one of the big topics was the general lack of big deals. Still, there were some general trends and for today, some news.
Investigators found that the U.S. Food and Drug Administration is approving drugs faster than ever. Unfortunately, it appears that the agency is also approving those drugs on less data and weaker evidence.
The first of the Insys Therapeutics executives found guilty of violating the Racketeer Influenced and Corrupt Organizations Act in May 2019 has been sentenced.
The FY20 Defense Appropriations Act provides funding to the Department of Defense Peer Reviewed Medical Research Program to support medical research projects of clear scientific merit and direct relevance to military health.
In a filing this week, the government said that tens of thousands of patients received “unreliable blood tests,” which deprived them of money and placed their health at risk.
In a painful blow to the San Francisco-based company, the committees voted unanimously, 27 to 0, not to recommend approval.
Candidates pointed out ways they would use the power of the federal government to lower the cost of medications in the United States.
The Institute of Cancer Research, London, strongly welcomes the recommendation by the Scottish Medicines Consortium to make the prostate cancer drug abiraterone, when given alongside hormone therapy, available to men with advanced prostate cancer as first-line treatment on the NHS in Scotland.
Auris Medical Holding Ltd. announced that the European Patent Office has issued a notice of “Intention to Grant” for its patent application entitled “Treatment of Tinnitus Through Modulation of Chloride Co-Transporter NKCC1 in the Auditory System”.