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 partial government shutdown is 31 days old, yet the U.S. Food and Drug Administration has maintained a steady list of drug approvals throughout that time. However, that approval rate could change next month.
China government officials told the Xinhua News Agency that the researcher who became world famous for using CRISPR on human embryos “will be transferred to public security authorities,” and the individuals involved in the research will be “severely dealt with according to the law.”
Last year was a record year for biotech initial public offerings (IPOs), but 2019 is off to a slow and rocky start because of the government shutdown, which today is in its 31st day.
The U.S. Food and Drug Administration (FDA) approved South Korea’s Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab).
Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee had a split vote, 8 to 8, on whether the overall benefits of Zynquista (sotagliflozin) outweiged the risk in order to support approval. This sends things back to the agency to make a final decision, which has a target action date of March 22, 2019.
Immunomedics was hoping for a green light from the U.S. Food and Drug Administration for its triple-negative breast cancer treatment, sacituzumab govitecan. However, this morning the company announced that approval will not likely be coming any time soon.
The Food & Drug Law Institute (FDLI) is pleased to announce the addition of two new members to the Board of Directors: Cathy Burgess, Partner, Alston & Bird; and Carla Cartwright, Director, Global Regulatory Policy, Johnson & Johnson.
The U.S. government has been pushing to increase access to experimental drugs over the last two years. On August 18, 2018, the RACE for Children Act was signed into law as part of the 2017 FDA Reauthorization Act, which amended the Pediatric Research Equity Act (PREA).
This follows a 2017 rejection by the agency, requesting more data. As Jefferies analyst Michael Yee wrote in a note to clients, Amgen is “back in the game.”
U.S. federal lawmakers are discussing various legislative plans that could lower the out-of-pocket expenses many Americans pay for their medications. The plans are coming from both chambers of Congress and with a divided government, lines in the sand will likely be drawn.