Researchers at Bar-Ilan University and the Galilee Medical Center identified an association between vitamin D deficiency and severity and mortality of COVID-19.
FDA’s ODAC Says Lilly & Innovent Must Run U.S. Trial
Business, Checkpoint Inhibitors, China, Clinical Trial Endpoints, Clinical Trials, Ethnicity, FDA/Regulatory, Lung Cancer, Oncologic Drugs Advisory Committee (ODAC), PD-1 Inhibitors, Primary Endpoints, Progression-Free Survival (PFS), R&D, Therapeutics, United StatesThe Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended that Eli Lilly and Co. and Innovent Biologics Inc. conduct a clinical trial applicable to the U.S. population for the lung cancer drug sintilimab. The U.S. FDA previously raised concerns over a clinical trial conducted entirely in China focused on a single ethnic group.
GSK-Vir therapy has neutralizing activity against Omicron sub-variant, data shows
Antibodies, Broadly Neutralizing Antibodies (bNAbs), Clinical Data, Clinical Trials, Columbia University, Covid-19 Data, COVID-19 Studies, GlaxoSmithKline, Monoclonal Antibodies, Omicron BA.2, R&D, Researchers, Sotrovimab, Vir BiotechnologyAn antibody-based COVID-19 therapy developed by GSK and Vir Biotechnology retains neutralizing activity against the emerging BA.2 form of the Omicron coronavirus variant, according to data from a laboratory study cited by Vir on February 10.
Germany’s Bayer won fast-track status from U.S. drugs regulators for a new blood thinner designed to prevent certain types of strokes, as the company seeks to follow up on the success of the anticoagulant Xarelto.
The U.S. Food and Drug Administration is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib), which is indicated for two types of lymphoma.
Many babies of mRNA-vaccinated moms have antibodies at 6 months; Moderate COVID tied to higher childbirth risks
Birth, Covid-19 Data, COVID-19 Infections, COVID-19 Studies, Eli Lilly, Infants, JAMA, Monoclonal Antibodies, Mothers, Pregnancies, R&D, Regeneron Pharmaceuticals, Severe Covid-19, United StatesAt 6 months of age, babies born to mothers vaccinated against COVID-19 during pregnancy are more likely to have antibodies against the virus in their blood than babies born to unvaccinated mothers who were infected while pregnant, a small study suggests. Additionally, contracting COVID-19 late in pregnancy is linked with a higher risk for obstetric complications, new data suggest.
The U.S. Food and Drug Administration approved Sanofi’s proposed drug to address red blood cell destruction in patients living with a rare form of anemia called cold agglutinin disease (CAD).
U.S. health officials on Feb. 4 said they are considering lengthening the recommended interval between the first two doses of the most widely used COVID-19 vaccines to eight weeks to lower the risk of heart inflammation and improve their effectiveness.
Alzheimer’s-like changes found in COVID patients’ brains; flu shot, mRNA booster safe together
Alzheimer's, Alzheimer’s & Dementia, Beta Amyloid, Brain, Brain Cells, Columbia University, Coronavirus Tests, COVID-19 booster shots, Dementia, Flu Vaccines, Lancet Respiratory Medicine, Messenger RNA (mRNA) Vaccines, mRNA-1273/Moderna COVID-19 Vaccine (Moderna), Poison, R&D, Sanofi, Seniors, TauPeople who die of severe COVID-19 have brain abnormalities that resemble changes seen in Alzheimer’s disease – accumulation of a protein called tau inside brain cells, and abnormal amounts of the protein beta-amyloid that accumulates into amyloid plaques – small studies found. In other news, seniors can safely get the high-dose flu vaccine and an mRNA COVID-19 booster dose at the same time, a new study confirms.
Sanofi still expects the French drugmaker’s COVID-19 vaccine to complete a phase 3 trial in first-quarter 2022 and reported a rise in fourth-quarter 2021 sales and earnings on Feb. 4.