EMA’s safety committee recently reviewed a number of risk and safety signals related to various COVID-19 vaccines
First, the committee known as PRAC (Pharmacovigilance Risk Assessment Committee)...
A JAMA Network Open study found that COVID-19 treatments hydroxychloroquine and lopinavir-ritonavir failed to show any significant benefit in hospitalized patients.
The study analyzed metrics such...
Johnson & Johnson recently announced that the rollout of its COVID-19 vaccine will resume in Europe.
The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee...
Eli Lilly and Company recently requested that FDA revoke the emergency use authorization for its COVID-19 antibody treatment.
The FDA’s authorization has allowed providers to use 700 milligrams...
The CDC and FDA are reviewing data involving six reported cases of a severe and rare kind of blood clot in individuals who received the Johnson & Johnson (Janssen) COVID-19 vaccine.
This comes...
Gilead recently announced that FDA approved Trodelvy for adults with unresectable, locally advanced, or metastatic triple-negative breast cancer (TNBC).
FDA based its approval on results from a Phase...
Many European countries, including Germany, France, Italy, and Spain recently suspended the use of AstraZeneca’s COVID-19 vaccine after experts found dangerous blood clots in some vaccine...
A recent JAMA Network Open study found that there are distinct COVID-19 antibody response profiles that vary based on age.
The cross-sectional study used 31,426 COVID-19 antibody test results from...
AstraZeneca recently announced that its COVID-19 vaccine was 76 percent effective against the coronavirus and 100 percent effective at preventing severe disease and hospitalization in a Phase 3...
The Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) recently reaffirmed the benefits of AstraZeneca’s COVID-19 vaccine.
The agencies stated that...
In an official letter to President Joe Biden, PhRMA and over 30 leaders in the biopharmaceutical warned that eliminating intellectual property (IP) protections in COVID-19 vaccine development could...
Pharmaceutical company bluebird bio recently announced that it suspended Phase 1/2 and Phase 3 studies of LentiGlobin gene therapy for sickle cell disease due to a suspected unexpected serious adverse...
Johnson & Johnson recently announced that a single-dose of its COVID-19 vaccine candidate, Ad26.COV2.S, was 66 percent effective at preventing moderate to severe coronavirus in a Phase 3 clinical...
Kaiser Permanente Vaccine Study Center, part of the company’s Northern California Division of Research, recently announced that it will oversee electronic patient records and uncover any adverse...
Pfizer and BioNTech recently announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 clinical trial of its COVID-19 vaccine candidate in Germany.
Specifically,...
Sanofi and GSK recently announced they will delay a program testing an adjuvanted COVID-19 vaccine after results from a Phase 1/2 study showed a low immune response in older adults.
The...
Roche recently announced a partnership with Moderna to utilize the Elecsys COVID-19 antibody test in Moderna’s mRNA-1273 vaccine research clinical trials.
The partnership will allow for easier...
Following a positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, FDA stated that it will rapidly work toward finalization and issuance of an emergency use...
Pfizer recently announced that 83 percent of patients in the ongoing Phase 1 study of its investigational multiple myeloma antibody drug achieved clinical response at the highest dose level.
The...
Ovid Therapeutics recently announced that the Phase 3 clinical trial of its rare disease drug for the treatment of Angelman syndrome did not meet primary endpoints.
Specifically, OV101, or...
