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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Opioid drugmakers being sued in the state of Connecticut are breathing a big sigh of relief today after a judge dismissed lawsuits filed by 37 different municipal governments.
Valio’s consumer-packaged infant formulas have received an export permit from the Chinese authorities.
Swiss pharma giant Novartis has found itself at the center of a legal battle that could determine if the company engaged in a research project that was a kickback in disguise.
Tuesday, January 8, was another busy day in San Francisco for the JP Morgan Healthcare Conference. One interesting sideline was the idea that the current government shutdown could complicate some deals.
Medigene AG reported today that an additional European Patent was granted for its dendritic cell (DC) vaccine platform.
Federal corporate tax cuts that were framed as a way to give a boost to employment across the United States have been more beneficial to companies and shareholders than the average worker or consumer, a new report issued by the advocacy group Americans for Tax Fairness shows.
Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.
According to reports, FDA Commissioner Scott Gottlieb will outline the formation of the Office of Drug Evaluation Sciences, a 52-member group, during his talk at the J.P. Morgan Healthcare Conference in San Francisco later today.
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. Let us know which topics you want to hear more about.
Yesterday, shareholders filed for a class action lawsuit against Tesaro in Delaware federal court, alleging that the merger is based on misleading financial analyses filed with the U.S. Securities and Exchange Commission (SEC).