Policy

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.
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An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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FDA
The approval marks the first time the FDA has approved a checkpoint inhibitor for the treatment of advanced renal cell cancer.
FDA
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
Under the terms of the deal, AbbVie will grant Germany-based Boehringer Ingelheim a non-exclusive license for Cyltezo, its biosimilar to Humira.