Tags : Women

Pharma

Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix

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

Regulatory

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment

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

Regulatory

GSK’s Zejula (niraparib) Receives FDA’s Approval for Late-line Treatment in

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

Pharma

Evotec Signs an Agreement with Celmatix to Develop Pre-Clinical Candidates

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

Pharma

Novartis Reports Results of Kisqali in Second Phase P-III MONALEESA-3

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

Regulatory

Palatin Technologies’ Vyleesi (bremelanotide injection) Receives FDA’s Approval for Premenopausal

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