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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Promore Pharma AB (publ) publishes its Interim report for the first quarter 2019 at 13.00 CET on 21 May 2019.
The approval marks the first time the FDA has approved a checkpoint inhibitor for the treatment of advanced renal cell cancer.
The panel opposed approval of Daiichi Sankyo’s AML drug but supported approval for its TGCT treatment.
GeoVax Labs, Inc. announced its financial results for the three months ended March 31, 2019 and provided an update on its corporate development progress.
TARA Biosystems, Inc. (TARA) today announced that the United States Patent and Trademark Office (USPTO) has issued US Patent 10,254,274 covering methods, compositions and devices for making and using three-dimensional biological tissues that mimic native physiology.
Evotec SE reported financial results and corporate updates for the first quarter of 2019.
Soligenix, Inc. announced its recent accomplishments and financial results for the quarter ended March 31, 2019.
Conference call and webcast (in English) today, May 14, 2019 at 3:00 pm CET / 9:00 am EST
Teijin Limited announced today that it has signed a research and development agreement with the Japan Agency for Medical Research and Development (AMED) to form an industry-government-academia partnership that will explore preventive and therapeutic drugs for frail elderly people as designated under AMED’s Cyclic Innovation for Clinical Empowerment program(CiCLE) in October 2018.
Record Sales of $4.25 Million, Sales Growth of 42%, and Material Net Earnings