Shots: The submission is based on P-III HELP study evaluating lanadelumab (300mg, q2w & q4w) vs PBO in 125 patients with HAE attack for 26wks. It also based on P-III […]readmore
Tags : reports
Shots: The submission is based on EV-301 and EV-201 trials in Japan. The P-III EV-301 trial assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with […]readmore
Shots: The P-III BLAZE-1 study involves assessing Bamlanivimab (700 mg) + Etesevimab (1400 mg) vs PBO in 769 COVID-19 patients aged ≥12yrs. who are at high risk for progressing to […]readmore
Shots: The P-III CANOPY-2 study involves assessing canakinumab (ACZ885) + CT (docetaxel) in 237 adults with LA/m-NSCLC, prior treatment with PD-L1 inhibitors and Pt-based CT. The study did not meet […]readmore
Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of […]readmore
Shots: The P-III SURPASS-2 trial involves assessing Tirzepatide (5/10/15mg) vs Semaglutide (1mg) in 1,879 patients in a ratio (1:1:1:1) with T2D inadequately controlled with ≥1500 mg/day metformin alone for 40wks. […]readmore
Shots: The P-III 20120215 study involves assessing of Blincyto vs SoC consolidation CT before alloHSCT in pediatric patients with high-risk first relapsed B-cell ALL. The findings were published in JAMA […]readmore
Shots: The NDA submission is based on two P-III studies (COUGH-1 & -2) involves assessing gefapixant (45/15mg, bid) vs PBO in 2,044 patients with RCC & UCC In both the […]readmore
Shots: Regeneron reported changes to the P-III study assessing REGEN-COV in non-hospitalized patients with COVID-19, following recommendations from the IDMC The IDMC found clear clinical efficacy in reducing the rate […]readmore
Shots: Otsuka and Click have reported the initiation of the Mirai study which is a fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing depressive symptoms […]readmore