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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ChromaDex to move forward with patent infringement action, following unsuccessful challenge by Elysium Health during Inter Partes Review (IPR)
In its year-end financial report, Johnson & Johnson (J&J) predicted product sales for 2019 to range from $80.4 billion to $81.2 billion, about $1 to $2 billion below what Wall Street analysts projected. The company thinks this will largely be due to increased biosimilar competition.
Taiwan Liposome Company, Ltd. today announced that the European Medicines Agency (EMA) has granted orphan drug designation for TLC178 for the treatment of soft tissue sarcoma.
A documentary about Theranos will be shown at Sundance, while ABC News will unveil its own documentary on the company this week.
Translate Bio did not provide information as to what questions or concerns the FDA has regarding the planned early-stage trial for mRT5201.
The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death.
As opioid lawsuits continue to wind through the courts, some drugmakers are focused on developing treatments for opioid addiction.
Researchers from A*STAR’s SBIC have discovered how changes in BCAA metabolism influence the development and progression of tumours, and pave the way for new approaches to prevent and treat certain cancers