In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears.
In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer.
No placebo recipients developed the condition.
Get the full story from our sister site, Drug Discovery & Development.
Photo by Miguel Á. Padriñán from Pexels
The market for injectable anti-HIV therapeutics will be worth $28 billion by 2029, according to projections from the analyst and consulting firm GlobalData.
GlobalData valued the broader HIV therapeutics market at $22.9 billion in 2019 across the U.S., France, Germany, Italy, Spain, U.K. and Japan.
While the overall market is growing at a low single-digit rate, injectable therapies will likely see more brisk growth, GlobalData projects.
To date, the majority of HIV therapies are orally-delivered antiretroviral drugs although a handful of injectable drugs have hit been introduced over the years.
Future injectable anti-HIV therapies could be administered less frequently than oral drugs.
One early injectable anti-HIV therapy, Fuzeon (enfuvirtide) from Roche (OTCMKTS:RHHBY), is administered multiple times per day, posing a challenge for adh…
Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine.
New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which met all of its primary and key secondary endpoints, according to a news release.
EUL submission is a step forward in the process for a new or unlicensed product to be assessed for use during public health emergencies by governments and UN procurement agencies. Such listing would offer the single-dose vaccine in many countries and is a prerequisite to supply vaccines to the new COVAX Facility for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.
Previously, J&J agreed in princ…
Johnson & Johnson (NYSE:JNJ) announced today that it submitted a conditional marketing authorization application (cMAA) for its COVID-19 vaccine.
New Brunswick, N.J.-based J&J’s cMAA application with the European Medicines Agency (EMA) is seeking authorization for the investigational, single-dose COVID-19 vaccine candidate developed by its Janssen subsidiary, according to a news release. The submission is based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its primary and key secondary endpoints.
The Janssen single-dose COVID-19 vaccine is estimated to remain stable for two years at -4°F (-20°C), at least three months of which can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C). J&J plans to ship it using the same cold chain technologies it uses to transport other medicines.
Earlier this month, the company applied for FDA emergency use authorization (EUA) in the U.S.,…