Janssen Pharmaceuticals of Johnson & Johnson recently announced that FDA has granted Breakthrough Therapy Designation (BTD) for its refractory T-cell therapy for multiple myeloma,...
Moderna recently announced that it initiated the rolling submission process for a Biologics License Application (BLA) for its mRNA COVID-19 vaccine.
The company will continue to submit data to support...
Although COVID-19 treatments azithromycin and hydroxychloroquine were often used in patients early in the pandemic, use decreased significantly by the end of 2020. But for drugs such as remdesivir and...
Johnson & Johnson recently announced efficacy and safety data for its biologic therapy, Stelara (ustekinumab) in treating patients with Crohn’s disease and ulcerative colitis.
The...
FDA recently approved Janssen’s Rybrevant as the first targeted therapy for patients with subset of non-small cell lung cancer.
The agency approved the therapy based on a study of 81...
Biogen and Capsigen recently entered into a collaboration to engineer novel adeno-associated virus (AAV) capsids to deliver gene therapies that address genetic causes of various central nervous system...
JAMA Network Open study found that change in brand-name medication prices for most commercially insured patients correlated with changes in out-of-pocket costs.
In the study, nearly 53.7 percent of...
Pfizer recently announced that it has acquired Amplyx Pharmaceuticals to expand its anti-infective therapies pipeline.
Amplyx’s lead compound, Fosmanogepix, is a novel investigational...
Abbott recently announced that its artificial intelligence-powered,coronary imaging platform launched in Europe.
The platform, which is now CE marked in Europe, is the first-of-its-kind imaging...
Health2047, a subsidiary of the American Medical Association (AMA), recently spun out SiteBridge Research to boost clinical trial access for small and community physician practices.
SiteBridge...
New COVID-19 drug therapies along with better clinical management of patients with SARS-CoV-2 infection may have contributed to reductions in in-hospital COVID-19 mortality rates, according to a recent...
FDA recently issued guidance on remote interactive evaluations of drug facilities where COVID-19 drugs are manufactured, processed, packaged, and held during the pandemic.
As part of the...
Gilead recently announced that it has stopped the Phase 3 clinical trial studying remdesivir in high-risk, non-hospitalized COVID-19 patients.
The company stated that it no longer believes...
Hologic, a global leader in women’s health, recently signed a $795 million definitive agreement to acquire Mobidiag Oy, a commercial stage developer of innovative molecular...
The New England Journal of Medicine (NEJM) recently released antibody persistence data six months following the second dose of Moderna’s COVID-19 vaccine, mRNA-1273.
As detected by three...
Nearly one in three antibiotic prescriptions written by doctors’ offices, emergency rooms, and hospital-based clinics are inappropriately prescribed annually. But effective and sustainable...
A recent study found that COVID-19 antigen test sensitivity is higher in individuals with signs and symptoms of the coronavirus, rather than in those without symptoms present.
In individuals...
Vir Biotechnology and GlaxoSmithKline (GSK) are stopping a Phase 3 clinical trial of its COVID-19 antibody early after data shows “profound efficacy,” according to a recent announcement...
FDA recently issued an emergency use authorization for an at-home and over-the-counter (OTC) COVID-19 diagnostic test.
The Cue COVID-19 Test for Home and OTC Use test is a molecular nucleic acid...
Eli Lilly & Company recently announced that the US government has agreed to purchase a minimum of 100,000 doses of its COVID-19 antibody therapy combination for $210 million.
The COVID-19...