Shots: The 2-year data from Part 2 of P-II/III FIREFISH study involves assessing Evrysdi in 41 infants aged 1-7mos. with symptomatic Type 1 SMA Results: improvement in maintained motor function b/w 12-24mos., babies were able to sit without support for at least 5sec. after 24mos. vs 12mos. (61% vs 29%), 92% maintained the ability to […]Read More
Shots: The P-III ORIENT-3 trial involves assessing the efficacy and safety of Tyvyt (sintilimab) vs docetaxel (q3w) in 290 patients in a ratio (1:1) as a 2L treatment for advanced or m-sqNSCLC The trial met its 1EP i.e improvement in OS, mOS (11.79 vs 8.25 mos.), mPFS (4.30 vs 2.79 mos.), ORR (25.5% vs 2.2%), […]Read More
Shots: The P-II KINETIC study involves assessing the efficacy, safety, and tolerability of SAGE-324 (60mg, qd) vs PBO in 69 patients in a ratio (1:1) aged 18-80yrs. with essential tremor for 29 days The study met its 1EPs i.e reduction from baseline in TETRAS Performance Subscale Item 4 upper limb tremor score @29day (36% vs […]Read More
Shots: The P-III CheckMate-816 study involves assessing Opdivo (360mg) + CT (q3w for 3 doses) vs CT, followed by surgery as a neoadjuvant treatment in 358 patients with resectable stage Ib to IIIa NSCLC The study met its 1EPs, i.e. improvement in pCR (24% vs 2.2%) and showed improvement in 2EPs i.e. MPR (36.9% vs […]Read More
Shots: The P-III CHRONOS-3 study involves assessing Aliqopa (IV) + rituximab vs PBO + rituximab in 458 patients with relapsed iNHL in extending PFS who have received at least one or more lines of prior rituximab-containing treatment Results: @median follow-up of 19.2mos., mPFS (21.5 vs 13.8 mos.), ORR (80.8% vs 47.7%), CR (33.9% and 14.6%), […]Read More
Shots: The P-III REGN-COV 2069 trial involves assessing the efficacy and safety of Ab cocktail (casirivimab (1200 mg, SC) + imdevimab (1200 mg, SC) vs PBO in 1,505 people to prevent symptomatic infection in household contacts of individuals infected with COVID-19 The trial met its 1EP and 2EPs showed an 81% reduction in the risk […]Read More
Shots: The P-III KEYNOTE-564 trial involves assessing Keytruda (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) as adjuvant therapy vs PBO in 950 patients with RCC, following nephrectomy and resection of metastatic lesions The study showed improvement in 1EPs i.e DFS while the trial will continue to evaluate its […]Read More
Shots: The company reported the data from the N-MOmentum trial involves assessing Uplizna in patients with NMOSD The results from the N-MOmentum trial demonstrated a reduction in pain, long-term safety, and efficacy outcomes. Additional results from the new survey demonstrated NMOSD patient attitudes towards diagnosis and treatment Uplizna is the first FDA-approved B-cell depleter to […]Read More
Shots: The P-III study evaluating BNT162b2 (COVID-19 Vaccine) vs PBO in >44,000 participants age ≥16 yrs with 927 confirmed symptomatic cases of COVID-19 The results demonstrated that BNT162b2 is 91.3% effective against COVID-19, follow-up time of at least 6 mos after the 2nd dose, 100% effective in preventing severe disease by CDC, 95.3% effective against […]Read More
Shots: The P-II PULSAR trial involves assessing Sotatercept (0.3 mg/kg or 0.3 mg/kg, SC, q3w) vs PBO in 106 patients in a ratio (3:3:4) with PAH. The results were published in NEJM The results of the P-II PULSAR study that demonstrated sotatercept has the potential to provide benefits to patients with PAH on top of […]Read More
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