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Moderna
Moderna’s mNEXSPIKE Receives the US FDA’s Approval to Protect Against COVID-19
Shots:The US FDA has approved mNEXSPIKE (mRNA-1283) for active immunization against COVID-19 in individuals (≥12yrs.) with ≥1 underlying risk factor as defined by Centers for Disease Control and Prevention; regulatory review is ongoing in other regionsApproval was based on P-III (NextCOVE) trial assessing mNEXSPIKE (10 or 50μg) vs Spikevax (mRNA-1273) in ~11,400 subjects…
Takeda at ASH 2024: Phuong Khanh Morrow from Takeda in a Riveting Conversation with PharmaShots
Takeda at ASH 2024: Phuong Khanh Morrow from Takeda in a Riveting Conversation with PharmaShots
Shots: Recently, at ASH 2024, Takeda presented data from several ongoing clinical trials across hematology and oncology, including the Phase II OPTIC and Phase III PhALLCON studies, among others Phuong Khanh Morrow, Head of the Oncology Therapeutic Area Unit at Takeda, shed light on Takeda’s key presentations at ASH 2024 Phuong also highlighted the findings…
Novartis
Novartis Reveals Interim P-III (PSMAddition) Trial Data of Pluvicto for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Shots:Novartis has reported interim P-III (PSMAddition) trial data assessing Pluvicto + SoC (ARPI + ADT) vs SoC in PSMA+ mHSPC adults, with pts switching to Pluvicto upon confirmation of radiographic progression & per physician's discretionTrial met its 1EP of improved rPFS, with favorable OS trend (2EP) observed; data to be shared in future…
Sandoz
Sandoz Launches Wyost and Jubbonti (Biosimilars, Xgeva and Prolia) in the US
Shots:Sandoz has launched Wyost & Jubbonti, interchangeable biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the USJubbonti (60mg/1mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase…
Blueprint Medicines
Sanofi to Acquire Blueprint Medicines for ~$9.5B
Shots:Sanofi to acquire Blueprint Medicines, expanding its rare immunological disease portfolioAs per the deal, Blueprint shareholders will receive $129/share in cash (~$9.1B equity value) & one non-tradeable CVR of $2 & $4 per share upon achievement of development & regulatory milestones, respectively, for BLU-808, totaling the deal value up to $9.5B on a…