Shots: The approval is based on P-III Archway study evaluates Susvimo (100 mg/mL, IV, q3mos.) via ocular implant vs ranibizumab (0.5mg, IV) in 415 patients with wet AMD prior responded to 2 anti- VEGF The results showed that the therapy achieved & maintained vision gains equivalent to ranibizumab @ 36 & 40wks.; 1.6% of patients […]Read More
Shots: The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma The results showed a 65% avg. reduction in the rate of severe asthma attacks @1yrs.; improvement in lung function by 5.32% points @ 12wks. & as early as 2wks. & sustained […]Read More
Shots: The approval is based on cohort 3 of a P-II/III study that evaluates Biktarvy (bictegravir 30mg/emtricitabine 120mg/tenofovir alafenamide 15mg) in 22 Pediatric patients with HIV-1 who are virologically suppressed or new to antiretroviral therapy The results showed that Biktarvy low-dose tablets were found to be effective & well-tolerated @24wks. After switching to Biktarvy, 91% […]Read More
Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases The study showed that Cyltezo was equivalent to Humira & demonstrated that switching several times b/w Cyltezo and Humira resulted in no clinical differences in PK, efficacy, immunogenicity, […]Read More
Shots: The approval is based on P-III IMpower010 study Tecentriq vs BSC in 1005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant cisplatin-based CT The results showed a 34% reduction in risk of disease recurrence or death in people with Stage II-IIIA NSCLC whose […]Read More
Shots: The US FDA has approved Keytryda + CT, with/out bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test The approval is based on the P-III KEYNOTE-826 trial that demonstrated superior OS and PFS, ORR (68% vs 50%), mDOR […]Read More
Shots: The approval is based on P-III IKEMA study assessing Sarclisa in combination with carfilzomib and dexamethasone (Kd) in 302 patients with relapsed MM who have received 1 to 3 prior lines of therapy across 69 centers spanning 16 countries The addition of Kd in Sarclisa leads to a 47% reduction in the risk of […]Read More
Shots: The approval is based on the P-III clinical trial program including Measure Up 1/2/AD Up that evaluates the efficacy & safety of Rinvoq (qd) as monothx. with TCS vs PBO in 2500+ adults & adolescents with AD In all three studies, the co-primary EPs showed 75% improvement in EASI 75 and vIGA-AD score of […]Read More
Shots: ViiV Healthcare has reported a regulatory submission to the US FDA for the approval of a new dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir & lamivudine. The submission is based on modeled data and in line with regulatory recommendations The company expands its approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower […]Read More
Shots: The approval was based on a P-I/II ZUMA-3 study assessing Tecartus in adult patients aged ≥18yrs. with ALL whose disease is refractory to or has relapsed following first standard systemic therapy with remission of 12mos. or less, after 2L+ systemic therapy or at least 100 days after ASCT Results: 65% of the evaluable patients […]Read More
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