Humanigen gets positive feedback from FDA ahead of emergency use application for coronavirus drug lenzilumab
The agency said no material changes are needed in the company’s chemistry, manufacturing & controls plan, EUA labeling and the statistical analysis plan Lenzilumab is designed to treat what is known as the cytokine storm, an overactive immune response to conditions such as COVID-19 that can cause inflammation, fatigue and, in severe cases, organ failure
Humanigen Inc (NASDAQ:HGEN) announced Friday that the US Food and Drug Administration said its Emergency Use Authorization (EUA) application for its coronavirus treatment lenzilumab may be sufficient, pending Phase 3 trial data.
Press release content from Business Wire. The AP news staff was not involved in its creation.
Humanigen Reports Fourth Quarter and Year-End 2020 Financial Results and Provides Corporate Update
March 10, 2021 GMT
BURLINGAME, Calif. (BUSINESS WIRE) Mar 10, 2021
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today reported financial results for the year ending December 31, 2020 and announced objectives for 2021.
“We are proud of all the advances Humanigen made in 2020, not just as a company, but as a key player in the development of an effective treatment for hospitalized COVID-19 patients,” said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. “We were able to take lenzilumab from the context of preventing and treating cytokine storm in other therapeutic categories and adapt it at unpr
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Tensions were high at the outset. The bill from Rep. Greg Chaney (R-Caldwell) would make it a misdemeanor to target anyone – whether they’re a public official or not – and picket in front of their home.
Chaney said he’s not trying to demonize anyone over their outrage due to COVID-19 restrictions.
“But even the Nazi Party started with good-intentioned persons who were frustrated and they were used over time to allow bad people to take power,” he said.
The bill stems from several protests last year at the homes of elected and appointed officials, and even a police officer, due to COVID-19 restrictions and their enforcement.
Humanigen to Present at J.P. Morgan Healthcare Conference
(Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ˜cytokine storm with its lead drug candidate, lenzilumab„¢, today announced that the Companys management will present and host meetings with investors and potential partners at the J.P. Morgan Healthcare Conference, held virtually from January 11 to 14, 2021. Cameron Durrant, MD, MBA, chief executive officer of Humanigen, Dale Chappell, MD, MBA, chief scientific officer, and Timothy Morris, chief operating and financial officer, will provide an update on enrollment for its Phase 3 clinical trial of lenzilumab in patients hospitalized with COVID-19, an update on the commercial preparation ahead of a potential Emergency Use Authorization (EUA) for lenzilumab as well as an overview of the Companys other programs.
December 10, 2020 at 6:00 am
As the coronavirus pandemic picked up speed this year, some people’s jobs became a nonstop race to help save lives. Here, an emergency medicine doctor, vaccine trial volunteer, protective equipment manufacturer, public health director and others share what 2020 was like for them.
The following interviews have been edited for length and clarity.
Yvette CalderonMount Sinai Health System
Yvette Calderon is chair of emergency medicine at Mount Sinai Beth Israel Hospital. She was on the front lines of New York’s City’s early pandemic surge.
Q: How did the pandemic change your work?
Calderon: It was a very stressful time. it was really important to check in with everyone nursing staff, faculty, residents, the [physician’s assistants] just to make sure we had a mental health check. We saw a lot of death, more than I’ve ever seen in a short period of time.