AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025

Shots: The P-III (NIAGARA) trial assessed Imfinzi (4 cycles + neoadj. CT; then 8 cycles alone) vs CT with surgery in MIBC pts ± pCR; ongoing regulatory review in the US, EU, Japan & other areas Trial met its 2EPs of improved MFS (75.1% vs 65.1%) & DSS (89.2% vs 82.2%) in ITT pts (N=1063)…

ByRidhi RastogiFebruary 17, 2025

NEWS

Navi Medical Technologies Receives the US FDA’s 510(k) Clearance for Neonav ECG Tip Location System

Shots: Navi Medical has reported the US FDA’s 510(k) clearance for Neonav ECG Tip Location System to improve pediatric vascular care, with plans to raise capital & engage hospitals to expand access in the US market The system uses real-time ECG analysis to facilitate CVAD placement in pediatric pts, reducing misplacement & migration risks…

ByRidhi RastogiFebruary 17, 2025

NEWS

Ono Pharmaceutical Reports the US FDA Approval of Romvimza to Treat Symptomatic Tenosynovial Giant Cell Tumor (TGCT) in Adults

Shots: The US FDA has approved Romvimza to treat symptomatic TGCT in adults for which surgery may lead to functional impairment or severe morbidity. Commercially available in the US by Feb 2025, whereas MAA is under EMA review Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs…

ByRidhi RastogiFebruary 17, 2025

NEWS

Anivive Lifesciences Completes Pivotal Field Study of Laverdia-CA1 (Verdinexor Tablets) for Canine Lymphoma

Shots: Anivive has reported completion of its pivotal trial of Laverdia-CA1 to treat dogs with lymphoma where, the final study site was closed on Dec 12, 2024 The trial assessed Laverdia-CA1 vs PBO in dogs (n=150; selected via AniviveTrial platform from >700 applications) in 12 US sites with results expected in coming months Additionally,…

ByRidhi RastogiFebruary 17, 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

Samsung Bioepis Reports the US FDA’s approval of Ospomyv & Xbryk (Biosimilar, Prolia & Xgeva)

Shots: The EC has approved SB16: Ospomyv (denosumab-dssb; 60mg pre-filled syringe) & Xbryk (denosumab-dssb; 120mg vial), a biosimilar version of Prolia & Xgeva for osteoporosis & prevention of skeletal related events, respectively Approval was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males, in terms of AUC from…

ByRidhi RastogiFebruary 16, 2025

NEWS

IDEAYA Enters Into an Additional Clinical Study Collaboration and Supply Agreement with Gilead Sciences

Shots: IDEAYAhas entered into an additional clinical study collaboration and supply agreement with Gilead Sciences to evaluate the efficacy and safety of IDE397 + Trodelvy in MTAP-Deletion NSCLC IDEAYA is currently enrolling patients in a monotx. expansion study for IDE397 in MTAP-deletion NSCLC and urothelial cancer, alongside the P-I/II study evaluating IDE397 with Trodelvy in…

ByRidhi RastogiFebruary 14, 2025

NEWS

Galderma’s Nemluvio (Nemolizumab) Secures the EU Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD) and Prurigo nodularis (PN)

Shots: Based on ARCADIA and OLYMPIA studies EU approved Nemluvio for moderate-to-severe AD and PN and is now approved for SC use in pts. aged 12 and older for AD and in adults for PN who are candidates for systemic therapy ARCADIA 1 & 2 studies assessed Nemluvio (Q4W) + TCS ± TCI vs PBO…

ByRidhi RastogiFebruary 14, 2025

NEWS

Sanofi and J&J Discontinue P-III (E.mbrace) Study of ExPEC9V for Invasive E. coli Diseases

Shots: Sanofi and J&J have discontinued the P-III (E.mbrace) study of ExPEC9V after IDMC interim analysis due to insufficient efficacy against extraintestinal pathogenic E. coli , leading to a $250M impairment charge before tax The P-III trial assessed single dose of ExPEC9V (IM) vs PBO in adults (≥60yrs.) with UTI history in past 2yrs. to prevent invasive…

ByRidhi RastogiFebruary 14, 2025

NEWS

Bayer Submits MAA of Finerenone to Japan’s MHLW for Heart Failure (HF)

Shots: Japan’s MHLW received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Regulatory review is ongoing in the US, EU & China, with global filings planned Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n>15000)…

ByRidhi RastogiFebruary 14, 2025

Ridhi Rastogi

AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025

Navi Medical Technologies Receives the US FDA’s 510(k) Clearance for Neonav ECG Tip Location System

Ono Pharmaceutical Reports the US FDA Approval of Romvimza to Treat Symptomatic Tenosynovial Giant Cell Tumor (TGCT) in Adults

Anivive Lifesciences Completes Pivotal Field Study of Laverdia-CA1 (Verdinexor Tablets) for Canine Lymphoma

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

Samsung Bioepis Reports the US FDA’s approval of Ospomyv & Xbryk (Biosimilar, Prolia & Xgeva)

IDEAYA Enters Into an Additional Clinical Study Collaboration and Supply Agreement with Gilead Sciences

Galderma’s Nemluvio (Nemolizumab) Secures the EU Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD) and Prurigo nodularis (PN)

Sanofi and J&J Discontinue P-III (E.mbrace) Study of ExPEC9V for Invasive E. coli Diseases

Bayer Submits MAA of Finerenone to Japan’s MHLW for Heart Failure (HF)

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