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.
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.
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.
No matter how effective it is, a drug is worthless if the people who need it can’t afford it. That’s been almost an anthem for patients and policy wonks testifying before U.S. Congress on drug prices.
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.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) looked with favor on a bucketload of would-be drugs, issuing positive opinions for the European Commission to consider across a range of indications.
Despite pressure from several lawmakers to declare the new coronavirus a U.S. public health emergency, Health and Human Services (HHS) Secretary Alex Azar said such a declaration isn’t needed, at least not yet.
The pending Abbvie Inc. merger with Allergan plc, expected to close in the first quarter, brought good tidings to another “A” company on Monday, allowing Astrazeneca plc to regain global rights to its late-stage Crohn’s disease and ulcerative colitis (UC) drug, brazikumab.