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…

BySaurabh ChaubeyApril 2, 2025

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)…

ByDipanshu DixitMarch 26, 2025

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…

ByRidhi RastogiMarch 4, 2025

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…

ByRidhi RastogiMarch 3, 2025

TOP 20

Top 20 Life Sciences Deals of 2024 by Total Deal Value 

Top 20 Life Sciences Deals of 2024 by Total Deal Value Shots: Life Sciences Dealmaking 2024 outlined a new genre of strategies for shaping global healthcare landscapes by targeting emerging technologies and addressing unmet needs In 2024, Arrowhead’s global licensing and commercialization deal with Sarepta Therapeutics for $11.37B ranked first in the list, followed by…

ByPrince GiriFebruary 20, 2025

NEWS

GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD

Shots: China’s NMPA has accepted the NDA for Nucala as an add-on treatment for COPD with eosinophilic phenotype based on P-III (MATINEE) study; global regulatory filings is ongoing The MATINEE study assessing Nucala (100mg, Q4W, SC) vs PBO in addition to inhaled triple therapy in COPD pts (n=804) with type 2 inflammation achieved its 1EP, showing…

ByRidhi RastogiFebruary 20, 2025

NEWS

GSK Reports the US FDA Approval of Penmenvy (MenABCWY Vaccine) for Protection Against Invasive Meningococcal Disease (IMD)

Shots: The US FDA has approved Penmenvy for individuals (10-25yrs) to protect against 5 serogroups of N. meningitidis (A, B, C, W, & Y) responsible for IMD. Meanwhile, the CDC's ACIP will vote on Feb 26, 2025, to recommend the use of Penmenvy in adolescents & young adults Approval was supported by 2 P-III…

ByRidhi RastogiFebruary 17, 2025

NEWS

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Shots: The EMA accepted depemokimab’s MAA 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, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…

BySenior EditorJanuary 28, 2025

NEWS

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer

Shots: The EC has approved Jemperli + CT (carboplatin & paclitaxel) as a 1L treatment of primary advanced or recurrent endometrial cancer in adults eligible for systemic therapy Approval was based on part 1 of P-III (RUBY) study assessing Jemperli + CT followed by Jemperli vs CT + PBO followed by PBO and part…

BySenior EditorJanuary 20, 2025

NEWS

GSK to Acquire IDRx for ~1.15B, Boosting its GI Cancer Portfolio

Shots: GSK to acquire IDRx incl. its lead candidate IDRX-42, for $1B upfront & ~$150M in regulatory milestones (total ~$1.15B). It will also pay success-based milestones & tiered royalties to Merck KGaA for IDRX-42 IDRX-42 (TKI, small molecule) targets key KIT mutations, responsible for proliferation & survival of tumor cells, & is under P-I/Ib…

BySenior EditorJanuary 13, 2025

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

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

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

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

Top 20 Life Sciences Deals of 2024 by Total Deal Value

GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD

GSK Reports the US FDA Approval of Penmenvy (MenABCWY Vaccine) for Protection Against Invasive Meningococcal Disease (IMD)

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer

GSK to Acquire IDRx for ~1.15B, Boosting its GI Cancer Portfolio

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