BEIJING – Five-year-old Jacobio Pharmaceuticals Co. Ltd., of Beijing, has found itself a strong global partner to help advance its two SHP2 inhibitors, JAB-3068 and JAB-3312, both financially and later in the regulatory process. The Chinese startup will work with pharma giant Abbvie Inc., of North Chicago, to develop and commercialize the programs.
CYBERSPACE – At a series of new drugs on the horizon sessions at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I, a variety of companies presented preclinical and clinical data for promising early stage oncology products.
Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.
Following a public backlash to Monday’s news that the FDA had granted Gilead Sciences Inc. an orphan drug designation for remdesivir, an antiviral in development to treat COVID-19, the Foster City, Calif., company is taking the unprecedented step of rescinding its request for the designation.
“For those of us who believe in a free market, it is really important that the market works well,” FDA Commissioner Stephen Hahn said March 9 at a public workshop on ensuring a U.S. biologic marketplace that includes sustainable biosimilar and interchangeable competition.
The Association for Accessible Medicines (AAM) is garnering support in its Ninth Circuit challenge to a new California law that seemingly thumbs its nose at a 2013 U.S. Supreme Court ruling on so-called pay-for-delay patent settlements.
At this very early point in the emerging 2019-nCoV outbreak, knowledge about the virus is insufficient to predict what shape that outbreak will ultimately take. But knowledge about the virus is accumulating at remarkable speed, and experience with other viruses is helping to shape the response to the newest coronavirus threat. 2019-nCoV, sometimes called Wuhan coronavirus after its source, is the third coronavirus after SARS-CoV and MERS-CoV with the potential to cause serious illness and death that has emerged since the beginning of the 21st century.