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Boston Pharmaceuticals

GSK to Acquire Efimosfermin Alfa from Boston Pharmaceuticals for ~$2B, Strengthening its Hepatology Pipeline

Shots: GSK to acquire Boston’s lead asset, efimosfermin alfa, a P-III candidate for steatotic liver disease (SLD) As per the deal, GSK will acquire BP Asset IX (Boston’s subsidiary) for ~$2B to access efimosfermin, incl. $1.2B upfront & $800M in milestones, plus GSK will also be responsible for royalties & milestone payments owed to Novartis…

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GSK New

GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: GSK has reported P-III (GLISTEN) trial data assessing linerixibat (n=119) vs PBO (n=119) to treat PBC pts (N=238) with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial Trial met its 1EP, showing significantly reduced itch per WI-NRS scale in PBC pts, as assessed by monthly itch score, over 24wks.…

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Top 20 Biopharma 2025

Top 20 Biopharma Companies of 2025 

Shots:  Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones  With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…

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Viewpoints_Vijay Nadipelli

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…

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

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…

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Viewpoints_Roger Levy

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…

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GSK

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)…

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GSK

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…

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