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.
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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 order would compel healthcare providers, such as hospitals, to disclose information about negotiated and discounted costs of care.
The regulatory agency is establishing new standards for the approval of opioid medications.
The data indicated that some surgeons prescribed more than 100 opioid pills for the week after a surgery. However, current guidelines from several academic medical centers called for zero to 10 pills for many of the procedures analyzed, with up to 30 for coronary bypass surgery.
Two weeks after filing a lawsuit against his former company from prison, Martin Shkreli has reached a settlement with Retrophin.
MagForce AG, a leading medical device company in the field of nanomedicine focused on oncology, published today its financial results as of and for the year ended December 31, 2018 as well as operative highlights.
The U.S. Food and Drug Administration (FDA)’s Circulatory System Devices Panel is in the middle of two days of presentations and meetings regarding mortality rates associated with the use of paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs). The discussions are noting missing data and conflicting analysis.
Lawsuits against the FDA are fairly common. However, winning the lawsuit will be a tough road for Catalyst, as other pharma companies that challenged the regulatory agency learned.
Scientists from the Agency for Science, Technology and Research’s Genome Institute of Singapore have identified two new Epstein-Barr Virus viral variants associated with cancers, including nasopharyngeal carcinoma, gastric cancer, and several kinds of lymphomas[2].
Trade tensions between Washington, D.C. and Beijing continue, but have not yet impacted the pharmaceutical products traded between the two countries. However, if the punitive tariffs continue and pharma is impacted, a third global player could step in to fill the void in both countries.
Transparency in clinical trials has been a concern and the new study highlights the continued issue.