Shots: Under Dzuveo agreement, AcelRx to receive ~$55M as an up front and commercial milestones in addition to 35% to 45% revenue share on net sales of Dzuveo. AcelRx will manufacture and supply Dzuveo while Aguettant gets the right to commercialize Dzuveo in the EU As per second agreement, Aguettant has the right to receive […]Read More
Shots: The conditional approval is based on P-II SPRINT Stratum 1 trial assessing selumetinib (PO, bid) as monothx. in pediatric patients aged >3yr. with NF1-related inoperable PNs. The trial was sponsored by NCI CTEP, conducted under a research & development agreement b/w NCI & AstraZeneca with additional support from NTAP The trial showed a reduction […]Read More
Shots: The submissions are based on P-III CHRONOS-3 trial evaluating copanlisib + rituximab vs PBO + rituximab in patients with relapsed iNHL in extending PFS, following at least one prior rituximab-containing therapy Results: improvement in 1EPs of PFS, AEs of the combination was generally consistent with previously published data on the individual components of the […]Read More
Shots: The approval is based on P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant CT as indicated for 3 yrs. or until disease recurrence Results: Improvement in DFS in all primary analysis population in Stage II and […]Read More
Shots: The P-III TIDES study involves assessing two doses of TAK-003 (0.5mL, SC on day 1 & 90) vs PBO to prevent laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 20,000+ children and adolescents Results: @36mos. after the second dose, 62.0% VE against VCD; 65.0% […]Read More
Shots: The recommendation is based P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant CT as indicated for 3 yrs. or until disease recurrence The study showed improvement in DFS in all primary analysis population of patients with […]Read More
Shots: EMA’s CHMP has recommended conditional marketing authorization of Selumetinib in the EU. The recommendation is based on the results from the P-I/II SPRINT Stratum 1 trial evaluating selumetinib as a monothx (PO, bid) in pediatric patients aged ≥3yrs. with NF1 and symptomatic, inoperable PNs The trial showed 66% ORR which is defined as the […]Read More
Shots: The CHMP has recommended the approval of Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L treatment for unresectable MPM and is based P-III CheckMate -743 trial that met its 1EPs of OS The opinion for Onureg is based P-III QUAZAR AML-001 study assessing Onureg (300mg, qd) vs PBO in 472 patients in a ratio (1:1) […]Read More
Shots: The approval is based on pivotal P-II DESTINY-Breast01 study involves assessing of Enhertu (5.4 mg/kg) in 184 patients as a monothx. for patients with unresectable/m-HER2+ BC prior treated with trastuzumab emtansine Results: @median follow up of 20.5mos., ORR (61.4%); CRR (54.9%); mDoR (20.8mos.). The safety of therapy has been evaluated in a pooled analysis […]Read More
Shots: Imfinzi has been approved in the EU and the UK for an additional dosing option (1500mg, fd, q4w) in LA, unresectable NSCLC in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based CRT New option extends dosing from 2 to 4wks. thus, reducing […]Read More
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