Tags : Treatment

GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in

Shots: The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count Results: The PRIMA study improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd […]Read More

Sanifit Presents Results of SNF472 for the Treatment of Vascular

Shots: The additional insight from the P-IIb CaLIPSO study showed that SNF472 slowed the progression of CAC across key subgroups of patients on hemodialysis participating in the study. The presentation highlights the PK/PD and exposure-response analyses Sanifit also presents the design of its ongoing P-III CALCIPHYX study evaluating the efficacy and safety of SNF472 for […]Read More

AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat

Shots: The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials P-III ETHOS study results reported that triple-combination therapy showed a reduction in the rate of moderate or severe exacerbations compared with the Bevespi […]Read More

AstraZeneca Advances its AZD7442 in Two P-III Clinical Studies for

Shots: The two studies of AZD7442 will enroll ~6,000 adults for the prevention of COVID-19 in and outside the US, expected to begin in next wk. with additional trials enrolling ~4,000 adults for the treatment of SARS-CoV-2 infections. The first study will evaluate the safety and efficacy of AZD7442 to prevent infection for up to […]Read More

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment

Shots: The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are […]Read More