GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≤50yrs. Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…

ByRidhi Rastogi10 hours ago

INSIGHTS+

EMA Marketing Authorization of New Drugs in May 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 4 Biologics and 2 New Chemical Entites in May 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were GSk’s Blenrep to Treat R/R Multiple Myeloma PharmaShots has compiled a list of 4 drugs that have been…

ByDipanshu Dixit3 days ago

News

GSK Reports the US FDA’s NDA Acceptance of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: The US FDA has accepted NDA of linerixibat for the treatment of cholestatic pruritus in PBC pts (PDUFA: Mar 24, 2026) NDA is supported by P-III (GLISTEN) trial assessing linerixibat (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial Trial…

ByRidhi RastogiJune 2, 2025

News

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 H2’25 The P-III (PIVOT-PO) trial assessed tebipenem pivoxil HBr (600mg, PO, every 6hrs.) vs imipenem-cilastin (500mg, IV, every…

ByRidhi RastogiMay 29, 2025

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 RastogiMay 27, 2025

News

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

S Shots: 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 RastogiMay 26, 2025

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 review MATINEE 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

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

EMA Marketing Authorization of New Drugs in May 2025

GSK Reports the US FDA’s NDA Acceptance of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

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

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