GSK & Spero Therapeutics Reports Early Conclusion of P-III (PIVOT-PO) Trial of Tebipenem HBr for Complicated Urinary Tract Infections (cUTIs)

Shots:GSK & Spero Therapeutics have reported early conclusion of P-III (PIVOT-PO) trial for efficacy of tebipenem HBr to treat cUTIs, incl. pyelonephritis following IDMC recommendation based on positive interim analysis; US FDA’s filing is expected in H2’25The P-III (PIVOT-PO) trial assessed tebipenem pivoxil HBr (600mg, PO, every 6hrs.) vs imipenem-cilastin (500mg, IV, every…

ByRidhi Rastogi1 day ago

News

GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Shots:Health Canada has accepted NDS of depemokimab as an adjunctive therapy for asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as inadequately controlled CRSwNP based on P-III (SWIFT & ANCHOR) trials, respectively SWIFT-1 (n=382) & SWIFT-2 (n=380) trials assessed depemokimab vs PBO + SoC, ICS & controller…

ByRidhi Rastogi3 days ago

News

GSK Receives the CHMP’s Positive Opinion for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

SShots:CHMP recommended Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; EC decision expected in Q3’25. Review ongoing in the US (PDUFA: Jul 23, 2025), Canada, China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8)Opinion was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494…

ByRidhi Rastogi5 days ago

News

GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots:The US FDA has approved Nucala as an add-on treatment for inadequately controlled COPD & eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA & NMPA’s submissions are under reviewMATINEE assessed Nucala (n=403; 100mg, SC, Q4W) vs PBO (n=401) in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…

ByRidhi RastogiMay 23, 2025

News

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots:MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8)Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…

ByRidhi RastogiMay 19, 2025

TOP 20

Top 20 Biopharma Deal Terminations of 2024

Shots: In the Biopharma industry, navigating M&A and licensing deals is challenging due to strict antitrust laws and shifting regulations. When these pressures create significant risks, nullifying or restructuring existing agreements can be the most rational and strategic response In 2024, the termination of the $4.45B deal between Adaptimmune and Genentech became a major talking…

ByPrince GiriMay 14, 2025

News

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…

ByRidhi RastogiMay 14, 2025

News

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 trialTrial met its 1EP, showing significantly reduced itch per WI-NRS scale in PBC pts, as assessed by monthly itch score, over 24wks.…

ByRidhi RastogiMay 8, 2025

TOP 20

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…

ByPrince GiriApril 24, 2025

News

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots:MHRA has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy incl. Revlimid; review ongoing in 14 markets incl. US (PDUFA: Jul 23, 2025), EU, Canada, Japan [priority review (PR)], China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8)Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep…

ByRidhi RastogiApril 21, 2025

GSK & Spero Therapeutics Reports Early Conclusion of P-III (PIVOT-PO) Trial of Tebipenem HBr for Complicated Urinary Tract Infections (cUTIs)

GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

GSK Receives the CHMP’s Positive Opinion for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Top 20 Biopharma Deal Terminations of 2024

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

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

Top 20 Biopharma Companies of 2025

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

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