Shots: Sitryx to receive $50M upfront, $10M equity investment, ~820M as development & commercial milestones and royalties on sales of therapies. Lilly to get an exclusive global license to develop and commercialize immunometabolism targeted therapies, including Sitryx’s two lead projects The companies will collaborate for 5yrs. supporting the development of therapies with Sitryx to be […]Read More
Shots: The EMA’s CHMP has adopted a positive opinion on a dosing and administration label update for AstraZeneca’s Lokelma to include patients with hyperkalemia on stable hemodialysis The recommendation is based on P-IIIb DIALIZE study assessing Lokelma (qd) vs PBO in 196 patients on non-dialysis days for 8wks. The study demonstrated that patients-maintained pre-dialysis potassium […]Read More
Shots: The US FDA has issued the EUA to the hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile (SNS) to be distributed and utilized to treat patients with COVID-19 The SNS will distribute anti-malarial drugs to the states for doctors to prescribe it to adolescent and adult patients hospitalized with COVID-19 and who […]Read More
Shots: The EC’s approval is based on P-III ARAMIS study assessing Nubeqa (600mg, bid) + ADT vs PBO + ADT 1,509 patients in a ratio (2:1) with nmCRPC The P-III ARAMIS study results: improvement in 1EPs of MFS (40.4 vs 18.4mos.), showed a delay in time to pain progression. Time to cytotoxic CT and time […]Read More
Shots: Abbott has received the US FDA’s EUA for its molecular point-of-care test to detect novel COVID-19 and runs on its ID NOW platform, delivering positive results in just five mins. and negative results in 13 mins. The ID NOW Covid-19 test allows HCPs to perform molecular POC testing outside the hospital in outbreak hotspots. […]Read More
Shots: The collaboration follows the existing partnership b/w J&J and BARDA while the company expects to initiate the clinical studies of selected vaccine candidates by Sept’2020 with the anticipated first batch of COVID-19 vaccine to be available for EUA in early 2021 Under the new agreement, J&J and BARDA to invest ~1B in research, development […]Read More
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. PharmaShots is keeping a track of all of the important updates in the Lifesciences sector, where […]Read More
Shots: The approval is based on P-III SUNBEAM & RADIANCE Part B studies assessing Zeposia (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI) vs Avonex (qw, IM) in 1,346 & 1,320 patients with RMS for at least 12 & 24mos. treatment period respectively The results will further be reviewed […]Read More
Shots: The approval is based on P-III study assessing Taltz (20mg for <25kg/40mg for 25-50kg/80 mg for >50 kg @12wks., with 40/80/160mg starting doses, respectively) vs PBO in 171 patients aged 6-18 yrs. with mod. to sev. PsO who are candidates for systemic therapy or phototherapy The P-III study results: patients achieving PASI 75 (89% […]Read More
Shots: The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and carboplatin / cisplatin CT, or Imfinzi + CT + tremelimumab vs CT as monothx. in 805 patients with ES-SCLC across 23 countries The Phase III CASPIAN study results: Imfinzi + SOC, reduction in risk of death by 27% with mOS (13.0 […]Read More
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