German biotech firm CureVac enrolled the first participant for a Phase 2b/3 clinical trial of the company’s Covid-19 vaccine candidate.
The U.S. Food and Drug Administration approved BioCryst Pharmaceuticals Inc.’s Orladeyo (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema in adults and young patients 12 years and older.
The U.S. Food and Drug Administration approved Genentech and Blueprint Medicines’ Gavreto (pralsetinib) as a treatment for adults and pediatric patients 12 and older who have been diagnosed with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC).
The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in children and adults.
The U.S. government will start distributing Regeneron Pharmaceuticals Inc.’s newly authorized Covid-19 antibody combination on Nov. 24, beginning with more than 30,000 treatment courses, a health official said.
The U.S. Food and Drug Administration issued emergency use authorization for Regeneron Pharmaceuticals Inc.’s Covid-19 antibody therapy, an experimental treatment given to U.S. President Donald Trump that he said helped cure him of the disease.
U.S. hospitals to restrict Lilly Covid-19 antibody treatment due to limited supply
Adults 65 and Older, Antibodies, Bamlanivimab (LY-CoV555), Coronavirus Disease (COVID-19) Pandemic, Coronavirus Infections, COVID-19 Antibodies, Donald Trump, Eli Lilly, Emergency Use Authorization, FDA, Federal Government, Healthcare Physicians, Hospitalized COVID-19 Patients, Hospitals, Immune System, Regeneron Pharmaceuticals, United StatesU.S. hospitals, weighing high demand and tight supplies, said they may limit use of the new Eli Lilly and Co. nantibody drug bamlanivimab to Covid-19 patients with multiple risk factors for serious illness or to those whose immune systems have not begun to fight the infection.
How Effective Will Lilly’s Bamlanivimab be in the Battle Against Covid-19?
Adults 65 and Older, Analysis, Bamlanivimab (LY-CoV555), Clinical Data, Clinical Trials, Coronavirus Disease 2019 (COVID-19), Emergency Use Authorization, FDA, Hospitalized COVID-19 Patients, Humanized IgG1 monoclonal antibody, Monoclonal Antibodies, R&D, ReutersThere are some questions about how effective Eli Lilly’s antibody neutralizing antibody bamlanivimab (LY-CoV555) will prove to be in the battle against Covid-19 due to labeling limitations.
A combination of Canadian drug developer Medicago’s experimental Covid-19 vaccine and a booster from Britain’s GlaxoSmithKline will enter a large study with more than 30,000 volunteers in 2020.
U.S. allows emergency use of first Covid-19 antibody drug
Adults 65 and Older, Business, Clinical Trials, COVID-19 antibody drugs, Dr. Anthony Fauci (Director), Emergency Use Authorization, FDA, Hospitalized COVID-19 Patients, Monoclonal Antibodies, R&D, Regeneron Pharmaceuticals, Shares, White HouseU.S. regulators authorized emergency use of the first experimental antibody drug for Covid-19 in patients who are not hospitalized but are at risk of serious illness because of their age or other conditions.