Zydus Lifesciences’ Menostar Transdermal System generic gets FDA final approval

Zydus Lifesciences’ Menostar Transdermal System generic gets FDA final approval

Zydus Lifesciences has secured final approval from the UA Food and Drug Administration (FDA) for Estradiol Transdermal System USP, 0.014 mg/day. The approved product which is to be used weekly is the generic version of Menostar Transdermal System and is approved for preventing postmenopausal osteoporosis. Zydus Lifesciences will manufacture the drug at its formulation manufacturing […]

Biocon Biologics signs licensing deal for two biosimilars with Yoshindo

Biocon Biologics signs licensing deal for two biosimilars with Yoshindo

Biocon Ltd. said that its subsidiary Biocon Biologics has signed an out-licensing agreement with Japanese pharma company Yoshindo Inc. for commercializing a couple of its pipeline biosimilar assets — bDenosumab and bUstekinumab in Japan. Ustekinumab is a biosimilar of the reference drug Stelara, which is a monoclonal antibody for the treatment of psoriasis, ulcerative colitis, […]

Amgen and UCB resubmit BLA for EVENITY to transform osteoporosis treatment in postmenopausal women

Amgen and UCB resubmit BLA for EVENITY to transform osteoporosis treatment in postmenopausal women

Amgen, in collaboration with UCB, has announced the resubmission of the biologics license application (BLA) for their osteoporosis drug candidate, EVENITY (romosozumab), to the US Food and Drug Administration (FDA). This resubmission is targeted at the treatment of osteoporosis in postmenopausal women who are at high risk of fractures, marking a significant development in the […]