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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FDA
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia are life-threatening hospital-related pulmonary infections that can particularly impact patients who are already dealing with severe underlying medical conditions.
Frontage Holdings Corporation, the parent company of Frontage Laboratories, Inc., a fast-growing contract research organization, specializing in R&D product development services, with operations in both the United States and China, announced on May 30th that the Company’s Shares have initiated trading on the Main Board of The Stock Exchange of Hong Kong.
Accsense Monitoring System Automates Data Archive and Alarming
Nivolumab plus ipilimumab meet primary endpoint of MD Anderson NEOSTAR Phase II trial
Last year, China invested $2.8 billion in U.S. health care companies, a big jump from the $702.9 million in 2017.
Help us identify the leading employers in the life science industry! We want to uncover who leads in key areas like diversity, culture, unique benefits and, of course, who are the 2019 Life Sciences Ideal Employers.
FDA
Medtronic plc announced U.S. Food and Drug Administration clearance and commercial launch for the SelectSite C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing.
The collaboration will establish a study protocol with an initial focus on breast cancer to provide the regulatory agency with information on the evolving treatment landscape, including insight on treatment variation within defined subpopulations of patients with the disease.
TARA Biosystems, Inc. announced the execution of an exclusive worldwide license agreement with Columbia University for intellectual property relating to engineered human heart tissues.