Tags : Prevention

Regeneron with its Partner NIAID Report the Initiation of P-III

Shots: The P-III trial involves assessing REGN-COV2 with an expected enrollment of 2000 patients at 100 sites which will be evaluated to prevent infection among uninfected people who have had close exposure to a COVID-19 patient REGN-COV2 is also being evaluated in P-II/III portion of two P-I/II/III trials testing the cocktail’s ability to treat hospitalized […]Read More

Regeneron Initiates its First Clinical Study of Antibody Cocktail for

Shots: The company has reported the initiation of the first clinical trial of REGN-COV2. The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people that are at high risk of exposure and uninfected people with close exposure to a COVID-19 patient The first two adaptive […]Read More

Roche’s CINtec PLUS Cytology Receives the US FDA’s Approval as

Shots: The US FDA has approved Roche’s CINtec PLUS Cytology as the first biomarker-based triage test for women with HPV positive results, screened by using the Cobas 4800 HPV test. The approval is based on IMPACT study validating CINtec PLUS Cytology as a triage test in different screening scenarios in 35,000+ women in the US […]Read More

Soligenix’s RiVax Receives the US FDA’s Fast Track Designation for

Shots: The US FDA has granted FT designation to RiVax (heat stable ricin toxin vaccine) to prevent ricin intoxication. Soligenix will submit BLA for the vaccine on a rolling basis, letting the FDA review sections of the BLA prior to receiving the complete submission FDA’s FT designation is intended to facilitate the development and expedite […]Read More

Merck’s Ervebo Vaccine Receives the US FDA’s Approval for Prevention

Shots: The approval is based on the study conducted in Guinea during the 2014-2016 outbreak in individuals 18 years of age and older evaluated 3,537 contacts with laboratory-confirmed EVD who received either “immediate” or 21-day “delayed” vaccination with Ervebo The study showed that Ervebo was 100% effective in preventing Ebola cases with symptom onset >10 […]Read More

GSK Reports Results of M72/AS01E in P-IIb Study for the

Shots: The P-IIb study involves assessing of M72/AS01E vs PBO in 3,573 adults in a ratio (1:1) to prevent Mycobacterium tuberculosis infection from developing pulmonary tuberculosis disease in tuberculosis-endemic regions across 11 sites in Kenya, South Africa and Zambia The P-IIb study results demonstrated a reduction in the incidence of pulmonary TB in HIV-negative adults […]Read More

Bayer Initiates P-III Study of Aflibercept for the Prevention of

Shots: The P-III study will assess the efficacy, safety and tolerability of Aflibercept (intravitreal) in ~100 infants with ROP across 34 countries Bayer & Regeneron collaborated to develop aflibercept whereas Regeneron holds exclusive rights to aflibercept in the US while Bayer retained exclusive marketing rights outside the US with equal profit sharing (Ex-Japan) Aflibercept (marketed […]Read More