Shots: The approval is based on safety & efficacy data from the P-III LIBERTY program that consists of 2 studies i.e LIBERTY 1 & 2 evaluating Ryeqo in adult women with UF with no limitation for a duration of use. The EC’s decision is valid in all 27 member states of the EU, Iceland, Norway […]Read More
Shots: The EC approval is based on data from an ongoing P-II trial evaluating Libtayo in 119 patients with LA BCC or metastatic BCC (nodal or distant) previously treated with an HHI to date Results: patients treated with advanced or m-BCC showed median follow-up (16 & 9mos.); ORR (32% & 29%), DOR (≥ 6 mos.) […]Read More
Shots: The EC approval is based on the P-III EMPOWER-Lung 1 trial evaluating Libtayo (350mg, q3w, for 108 wks.) monothx. vs platinum doublet CT as 1L treatment in 710 patients in a ratio (1:1) with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells & without EGFR, ALK, or ROS1 aberrations Results: […]Read More
Shots: The approval is based on efficacy & safety results from the P-III ECZTRA 1, 2 & 3 trials which evaluates Adtralza (300mg, SC) as monthx vs PBO in 1900+ adult patients with a mod. to sev. AD who are candidates for systemic therapy Results: improvement in signs & symptoms with treatment response rates gradually […]Read More
Shots: The EC approval is based on a P-III TERIKIDS study evaluating Aubagioin vs PBO in 166 pediatric patients aged 10-17yrs. with RRMS across 22 countries globally, where a screening period (4wks.) is followed by a double-blind treatment period for ~96wks. The 1EPs is not significant with numerically a lower risk (-34%) of clinical relapse […]Read More
Shots: The approval is based on P-III VIALE-A and P-Ib M14-358 studies. The P-III study involves assessing Venclyxto + azacitidine in patients with newly diagnosed AML who were ineligible for intensive CT and demonstrated OS (14.7mos. vs 9.6mos.), CCCR (66.4% vs 28.3%), CR (36.7% vs 17.9%) The P-Ib M14-358 trial involves assessing in Venclyxto + […]Read More
Shots: The MAA is based on a P-III BLISS-LN study assessing the efficacy and safety of belimumab (10 mg/kg, IV) + standard therapy vs PBO + standard therapy in 448 patients with active lupus nephritis for 104 wks. The study met its 1EPs i.e patients who achieved PERR @2yrs. (43% vs 32%) and has achieved […]Read More
Shots: The EC has granted conditional approval for Jemperli in women with dMMR/ MSI-H endometrial cancer that has progressed on or following prior treatment with a Pt.- containing regimen AnaptysBio has received $10M as milestones upon the EC’s approval and will receive $35M as regulatory milestones in the US & EU, $165M as sales milestones […]Read More
Shots: The approval is based on P-III study evaluating cannabidiol (25 mg/kg/day) vs PBO in patients aged ≥2yrs. as an adjunctive treatment of seizures associated with TSC The study met its 1EPs i.e reduction in seizure frequency (49% vs 27%). The 2EPs supports the effects on 1EPs and safety profile was consistent with findings from […]Read More
Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC Results: @median follow-up of 10.6 mos.; m-PFS (16.6 vs 8.3mos.), ORR (55.7% vs 27.1%); CR (9.3% vs 4.3%); OS (40% reduction in risk of death), Grade 3+ AEs […]Read More
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