Shots: The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone with influenza confirmed by a rapid influenza diagnostic test Results: The proportion of household members aged ≥12yrs. who developed influenza (1% vs 13%), well-tolerated with no new safety signals Xofluza […]Read More
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
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
Shots: NICE has recommended Ajovy in its final appraisal document (FAD) to prevent migraine in patients with chronic migraine who have not responded to at least three prior preventive drug treatments The recommendation is based on a dossier submitted to NICE for a single technology appraisal (STA). Following the issuance of the FAD, NICE will […]Read More
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
Shots: Barhemsys is the first and only antiemetic to be approved for the rescue treatment of PONV in patients who have failed standard prophylaxis with its anticipated launch in H2’20 The results of the clinical program showed that Barhemsys (10mg) is significantly more effective compare to PBO (42% vs 29%) while in another study Barhemsys […]Read More
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
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
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
Shots: Novartis, Amgen and Banner Alzheimer’s Institute discontinue two P-II/III studies evaluating the safety & efficacy of CNP520 for the prevention or the delay of the onset of Alzheimer’s disease due to lack of efficacy and worsening of cognitive function in the patients In Aug’2015, Amgen & Novartis collaborated to develop & commercialize therapies for […]Read More
Copyright ©2021 PharmaShots | Powered by Octavus Consulting
