To quell concerns over the politicization of a potential vaccine for the novel coronavirus, nine pharmaceutical companies developing a preventative treatment signed a pledge promising to uphold the integrity of the scientific process ahead of any potential approval of a medication.
At Least 4 Novel Coronavirus Vaccine Candidates Backed by U.S. Government Predicated to Fail, Analytics Group Says
"Operation Warp Speed" Initiative, Analytics, Antibodies, Biostatistics, Business, Clinical Trials, Coronavirus Vaccines, Donald Trump, Dr. Anthony Fauci (Director), National Institute of Allergy and Infectious Diseases (NIAID), R&D, U.S. governmentAt least four of six different vaccine candidates financially backed by the U.S. government aimed at the novel coronavirus are predicted to fail in the clinic, according to a draft report from an analytics group cited by CNBC.
AstraZeneca’s Covid-19 vaccine candidate begins late-stage U.S. study
"Operation Warp Speed" Initiative, Brazil, Britain, Clinical Trials, Coronavirus Infections, Covid-19 Data, COVID-19 Vaccines, Elections, Emergency Departments, Japan, National Institutes of Health, Novel Coronavirus, Oxford University, Placebo, R&D, Russia, South Africa, StudiesAstraZeneca Plc has begun enrolling adults for a U.S.-funded, 30,000-subject late-stage study of the company’s high-profile Covid-19 vaccine candidate.
FDA Action Alert: Bristol Myers Squibb/Juno, Seattle Genetics, BioMarin and Tricida
Adeno-Associated Virus (AAV), B Cell Lymphomas, Biologics License Application (BLA), Brain Metastases, CAR-T Therapy, Chronic Kidney Disease, Diffuse large B-cell lymphoma (DLBCL), FDA, FDA/Regulatory, Hemophilia A, HER2-positive breast cancer, Immunotherapy, New Drug Applicationa, Project Orbis, Quarterly results, T-CellsThe U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
The United States is tying payments for Covid-19 vaccines to timing milestones for production and approval, according to public documents and a Trump administration official, putting pressure on drugmakers including Moderna Inc. to meet ambitious targets.
Top U.S. health official says approval of COVID vaccines unlikely before November
"Operation Warp Speed" Initiative, Clinical Trials, Coronavirus Disease 2019 (COVID-19), COVID-19 Vaccines, Donald Trump, FDA/Regulatory, Health Officials, National Institutes of Health, R&D, Trump Administration, U.S. government, United States(Reuters) – Any potential COVID-19 vaccine backed by the Trump administration’s “Operation Warp Speed” program is unlikely to receive a green light from regulators any earlier than November or December, […]
The United States entered an agreement with drugmaker Moderna Inc. to acquire 100 million doses of the company’s potential COVID-19 vaccine for around $1.5 billion, the company and White House said.
Omeros’ COVID-19 treatment shows promise, shares jump
"Operation Warp Speed" Initiative, Acute Respiratory Distress Syndrome (ARDS), Breakthrough Status, Business, Clinical Trials, Coronavirus Disease 2019 (COVID-19), Hospitals, Italy, Monoclonal Antibodies, R&D, Shares, Stem Cell Transplant, U.S. governmentOmeros Corp.’s experimental treatment helped six patients with acute respiratory distress syndrome caused by Covid-19 recover and get discharged from the hospital, sending the drug developer’s shares up 60%.
GlaxoSmithKline and Sanofi struck a $2.1 billion deal with the U.S. government’s Operation Warp Speed program to supply an initial 100 million doses of a Covid-19 vaccine candidate under development by the two companies.
The National Institutes of Health is investing $248.7 million in seven diagnostic companies with new testing technologies to increase their testing capacities and make millions of rapid Covid-19 tests per week available by fall.