Shots: Myovant & Pfizer will jointly develop & commercialize ORGOVYX (relugolix) in advanced prostate cancer & if approved, relugolix combination tablet in women’s health in the US & Canada. Myovant will receive ~$4.2B including $650M upfront, $200M in regulatory milestones for FDA approvals for relugolix combination tablet in women’s health, and tiered sales milestones upon […]Read More
Shots: The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC The study met its 2EPs of OS, demonstrating a significant improvement in OS, and is consistent for the NSAI population & across exploratory subgroups, m-OS was not reached while […]Read More
Shots: The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are […]Read More
Shots: The P-III IMagyn050 study involves assessing of Tecentriq + Avastin, paclitaxel, and carboplatin vs PBO + Avastin, paclitaxel and carboplatin in the ratio (1:1) in women with Stage III or IV ovarian cancer who are undergoing neoadjuvant or adjuvant therapy The study did not meet its 1EP i.e. PFS while the safety data were consistent […]Read More
Shots: The approval is based on P-III PRIMA study assessing Zejula (300/200mg, qd) vs PBO in patients with newly diagnosed advanced ovarian cancer following complete or partial response to platinum-based CT regardless of biomarker status The P-III PRIMA study resulted in a 57% improvement in PFS in HRd population and a 38% reduction in the […]Read More
Shots: The approval for the expanded indication is based on P-II QUADRA study assessing Zejula (niraparib) in 463 patients relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer prior treated with >3 CT regimen and whose cancer is associated with homologous recombination deficiency (HRD) The P-II QUADRA study results demonstrated ORR (24%) with […]Read More
Shots: Evotec will take care of medicinal chemistry, in vitro and in vivo pharmacology plus its development capabilities and expertise while Celmatix will utilize its novel drug target discovery based on its multi-omics Reproductive Atlas platform The focus of the agreement is to combine Celmatix database and expertise with Evotec’s footprints in therapeutic discovery with […]Read More
Shots: Astellas to initiate global BRIGHT SKY program which includes three P-III studies (SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4) and will assess fezolinetant (30/45mg, qd) in postmenopausal women with VMS i.e, hot flashes and night sweats associated with menopause. The P-III SKYLIGHT 1&2 will assess Fezolinetant vs PBO for 12wks. and will each enroll […]Read More
Shots: The P-III MONALEESA-3 study involves assessing of Kisqali (ribociclib) + fulvestrant in postmenopausal women with HR+/HER2- advanced or m-breast cancer The second phase of P-III MONALEESA-3 study resulted in meeting its 2EPs of OS with no new observed safety signals and consistent AEs with the previous P-III study results. These results follow MONALEESA-7 study results […]Read More
Shots: Vyleesi (SC) is a pre-filled autoinjector pen used in anticipation of a sexual encounter melanocortin receptor agonist, approved for premenopausal women experiencing distress or interpersonal difficulty due to low sexual desire In 2017, Palatin signed an agreement with AMAG pharmaceuticals for commercialization of Vyleesi. Palatin to receive $60M on FDA’s approval with milestones based […]Read More
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