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Viewpoints_Vijay Nadipelli
VIEWPOINTS

Evaluating SDoH in SLE: Vijay Nadipelli from GSK in a Riveting Conversation with PharmaShots

Shots:  SDoH screening can help identify patient needs, support faster clinical decisions, and improve patient-centric care  A first-of-its-kind lupus study surveyed 69 patients across two institutions to assess the feasibility of routine SDoH screening in lupus clinics and identify related barriers and enablers at the physician, care team, and patient levels  Vijay Nadipelli, Senior Director…
April 21, 2025

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Insights+: The US FDA New Drug Approvals in August 2023
INSIGHTS+

The US FDA New Drug Approvals in March 2025

Shots:      PharmaShots has compiled a list of US FDA-approved drugs in the month of March 2025       The US FDA has approved a total of 2 new drug including 2 new molecular entities leading to the treatment of patients and advances in the healthcare industry        The major highlighted drug was GSK’s Blujepa securing approval for treating…
April 15, 2025

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Viewpoints_Roger Levy
VIEWPOINTS

Evaluating SDoH in Lupus Nephritis: Roger Levy from GSK in a Stimulating Conversation with PharmaShots

Shots:  GSK presented data at the American College of Rheumatology from a multi-center cohort study highlighting the achievement of complete renal response in patients with active lupus nephritis  The study evaluated the attainment of modified complete renal response (mCRR) in patients with systemic lupus erythematosus (SLE) and active lupus nephritis (LN), comparing characteristics between mCRR…
April 2, 2025

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GSK
NEWS

GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)

Shots: The US FDA has approved Blujepa to treat uUTIs in female adults (≥40kg) & adolescents (≥12yrs., ≥40kg) caused by E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus & E. faecalis; commercially available in H2’25 Approval was based on P-III (EAGLE-2, n=1531; EAGLE-3, n=1605) studies assessing gepotidacin (1500mg, PO, BID for 5 days) vs nitrofurantoin (100mg, PO, BID for 5 days)…
March 26, 2025

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GSK
NEWS

The US FDA Accepts GSK’s Depemokimab Review Application for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The FDA has accepted review application for BLA of depemokimab as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP (PDUFA: Dec 16, 2025), based on P-III (SWIFT & ANCHOR) trials, respectively SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…
March 4, 2025

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GSK
NEWS

GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025

Shots: The P-III (ANCHOR-1: N=271, ANCHOR-2: N=257) trial assessed depemokimab + SoC vs PBO + SoC in CRSwNP pts that showed early benefits lasting over 52wks. ANCHOR data with SWIFT-1 & 2 trial data will support global filings for asthma with type 2 inflammation & CRSwNP Pooled analysis of 2EPs showed 0.7-point NPS decrease (-0.9 to…
March 3, 2025

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