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Regeneron Enters a ~$2B In-Licensing Deal with Hansoh Pharma for HS-20094, Expanding its Obesity Portfolio

Shots: Regeneron has entered into an in-licensing agreement with Hansoh for exclusive global clinical development & commercialization rights of HS-20094, excl. Mainland China, Hong Kong & Macau As per the deal, Hansoh will receive $80M upfront & ~$1.93B in development, regulatory & sales milestones, with low double digits royalties on sales in Regeneron-licensed areas HS-20094…
June 3, 20250Comments

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Moderna
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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 regions Approval was based on P-III (NextCOVE) trial assessing mNEXSPIKE (10 or 50μg) vs Spikevax (mRNA-1273) in ~11,400 subjects…
June 3, 20250Comments

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Takeda at ASH 2024: Phuong Khanh Morrow from Takeda in a Riveting Conversation with PharmaShots
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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…
June 2, 20250Comments

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Novartis
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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 discretion Trial met its 1EP of improved rPFS, with favorable OS trend (2EP) observed; data to be shared in future…
June 2, 20250Comments

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Sandoz
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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 US Jubbonti (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…
June 2, 20250Comments

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GSK
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GSK Reports the US FDA’s NDA Acceptance of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: The US FDA has accepted NDA of linerixibat for the treatment of cholestatic pruritus in PBC pts (PDUFA: Mar 24, 2026) NDA is supported by P-III (GLISTEN) trial assessing linerixibat (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial Trial…
June 2, 20250Comments

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