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 only other drug currently approved in the U.S. for HIV PrEP is Gilead’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
Trump said that the pharma industry was looking for payback due to his administration’s efforts to lower the costs of prescription drugs.
The NOAA RESTORE Science Program has awarded approximately $15.6 million in grants to four teams of researchers and resource managers from across 20 institutions including universities, federal and state agencies and non-governmental organizations to support work on living coastal and marine resources and their habitats in the Gulf of Mexico.
In 2017, a lawsuit was filed alleging that Eli Lilly and Bayer, as well as other companies, attempted to use the free nursing services as a way to boost sales of diabetes drugs, such as Humalog and Humulin, as well as other drugs.
Heidelberg Pharma AG announced that it has adjusted its guidance for the current fiscal year published in March 2019.
According to multiple reports, President Donald Trump is set to pick Hahn, a noted radiation oncologist, as the successor to Scott Gottlieb.
Johnson & Johnson reached a $20 million settlement agreement with two Ohio counties for its role in the opioid crisis ahead of a watershed trial set to take place later this month involving multiple companies and lawsuits.
CELLINK is receiving a patent from the U.S. Patent and Trademark Office for the design of the company’s flagship bioprinter.
Magnetic Insight, Inc., the leader in Magnetic Particle Imaging solutions, announced that it was awarded a Small Business Innovation Research grant from the National Cancer Institute of the National Institutes of Health under Award Number R43CA233155.
Amryt, a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases, announces interim results for the six months ended 30 June 2019.