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Amgen
News
Amgen Reports Data from the P-III (FORTITUDE-101) Study Evaluating Bemarituzumab in FGFR2b+ 1L Gastric Cancer
Amgen’s P-III (FORTITUDE-101) study (n=547) met its 1EP at interim analysis, showing statistically significant OS improvement with bemarituzumab + CT (mFOLFOX6) vs PBO + CT in FGFR2b+ unresectable locally advanced/metastatic G/GEJ cancer (FGFR2b ≥10% IHC 2+/3+) P-III (FORTITUDE-101) study 2EPs include PFS and ORR; the safety profile of bemarituzumab + CT was consistent with prior…
July 1, 20250Comments
News
Neurocrine Biosciences Initiates P-I Study of NBIP-01435 to Treat CAH
Neurocrine initiated a P-I first-in-human study of NBIP-01435 to assess safety, PK/PD, tolerability, and immunogenicity in healthy adults via SC injection for the potential treatment of congenital adrenal hyperplasia (CAH) NBIP-01435 (CRF1 antagonist) aims to improve androgen control and reduce glucocorticoid dosing. In Dec’24, the FDA approved Neurocrine's crinecerfont, an oral CRF1 antagonist, to treat…
July 1, 20250Comments
VIEWPOINTS
Unlocking Approval: Christophe Piketty from Galderma in an Illuminating Conversation with PharmaShots 
Shots:   Backed by positive results from the P-III ARCADIA study, Galderma’s Nemluvio recently received approval from the US FDA for patients with moderate to severe atopic dermatitis  Nemluvio (nemolizumab) has previously been approved for the treatment of prurigo nodularis  Christophe Piketty, VP, Head of Innovation, Therapeutic Dermatology, Global Clinical Sciences, Galderma, highlighted insights from the…
June 30, 20250Comments
10 Hidden Financial Risks Pharma Professionals Can’t Ignore
THOUGHTSPOT
10 Hidden Financial Risks Pharma Professionals Can’t Ignore
Working in the pharmaceutical industry comes with great rewards—but it’s not without its financial blind spots. High income, stock options, consulting gigs, and regulatory risk make this a unique environment where professionals can be exposed without realizing it.  If you’re focused on research, development, or clinical work, it’s easy to overlook personal finance strategy. But…
June 30, 20250Comments
The Evolving Role of Nurses in the Pharmaceutical Industry
THOUGHTSPOT
The Evolving Role of Nurses in the Pharmaceutical Industry
In today’s rapidly changing healthcare world, nurses are stepping into roles that go far beyond traditional bedside care. With the healthcare system becoming increasingly interconnected and innovation reshaping how care is delivered, new opportunities are emerging that allow nurses to use their clinical expertise in areas once reserved for scientists, researchers, and corporate professionals. One…
June 30, 20250Comments
News
Sobi Reports the US FDA Approval of Gamifant for Macrophage Activation Syndrome in Still’s Disease
Shots: The US FDA has approved Gamifant (emapalumab-lzsg) for treating hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still's disease, including systemic Juvenile Idiopathic Arthritis (sJIA), in pts of all ages who are unresponsive, intolerant to glucocorticoids, or have recurrent MAS Approval was based on pooled data from two pivotal trials, P-III (EMERALD) and P-II (NI-0501-06),…
June 30, 20250Comments