NEWS

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, 2025

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, 2025

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, 2025

AstraZeneca Presents P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for G/GEJ Cancers at ASCO 2025

Shots: AstraZeneca has shared P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (n=474) vs PBO + FLOT (n=474) in 948 pts with stage II-IVA G/GEJ cancers at ASCO 2025 Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi (2 cycles with FLOT CT + 10…

June 2, 2025

Sanofi to Acquire Blueprint Medicines for ~$9.5B

Shots: Sanofi to acquire Blueprint Medicines, expanding its rare immunological disease portfolio As 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…

June 2, 2025

Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

Shots: The US FDA has accepted NDA & granted priority review seeking full approval of ziftomenib to treat adults with r/r acute myeloid leukemia (AML) with NPM1 mutation (PDUFA: Nov 30, 2025) NDA is supported by P-II (KOMET-001) trial assessing ziftomenib in r/r NPM1-mutant AML pts, which met its 1EP of CR & CR with…

June 2, 2025

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

Shots: CoreMap received the US FDA’s IDE approval of CoreMap EP (Endocardial Electrophysiology) to extend the 3-phase INvENI clinical study into the US in pts with Atrial Fibrillation (AF) and long-standing persistent AF The P-I study assessed acute safety of CoreMap EP in 14 pts while P-II study showed acute safety & effectiveness in 15 pts. The…

May 30, 2025

Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer

Shots: The NMPA has granted conditional approval to zanidatamab for the treatment of pts with previously treated, inoperable or metastatic HER2+ biliary tract cancer (BTC) following the CHMP’s positive opinion in Apr 2025 Approval was based on P-IIb (HERIZON-BTC-01) trial, which assessed anti-tumor activity of zanidatamab monotx. in HER2+ inoperable & advanced or metastatic BTC Approval…

May 30, 2025

Reflow Medical’s Spur Peripheral Retrievable Stent System Receives the US FDA’s De Novo Clearance for BTK-CLTI Treatment

Shots: FDA has granted De Novo clearance to the Spur Stent System for treating de novo or restenotic lesions post-predilatation in pts with infrapopliteal arterial disease In recently concluded DEEPER REVEAL trial (n=130), the system achieved 99.2% technical success rate & 97% freedom from MALE & POD at 30 days post-predilatation for below-the-knee (BTK) treatment…

May 30, 2025

Genentech Reports P-II (FENopta) Trial Data of Fenebrutinib for Relapsing Multiple Sclerosis (RMS)

Shots: Genentech has reported 96wk. data from P-II (FENopta) trial assessing fenebrutinib vs PBO for 12wks. in 109 RMS pts (18-55yrs.); 99 pts then opted for a 192wk. OLE study, with 93 remaining after 96wks. OLE study showed sustained efficacy over 96wks. with a low ARR of 0.06, no disability progression (per EDSS) & no…

May 30, 2025

NEWS

Novartis Reveals Interim P-III (PSMAddition) Trial Data of Pluvicto for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Sandoz Launches Wyost and Jubbonti (Biosimilars, Xgeva and Prolia) in the US

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

AstraZeneca Presents P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for G/GEJ Cancers at ASCO 2025

Sanofi to Acquire Blueprint Medicines for ~$9.5B

Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

CoreMap Reports the US FDA’s IDE Approval for CoreMap’s EP Map-Guided AF Ablation Study

Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer

Reflow Medical’s Spur Peripheral Retrievable Stent System Receives the US FDA’s De Novo Clearance for BTK-CLTI Treatment

Genentech Reports P-II (FENopta) Trial Data of Fenebrutinib for Relapsing Multiple Sclerosis (RMS)

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