Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Shots: The US FDA has accepted & granted priority review to the sBLA of Dupixent for the treatment of adults with BP (PDUFA: Jun 20, 2025) sBLA was supported by P-II/III (ADEPT) trial assessing Dupixent vs PBO in pts (n=106) for 52wks., that met its 1EP of 5x pts achieving sustained disease remission at…

ByRidhi RastogiFebruary 18, 2025

NEWS

The US FDA Approves MED-EL’s Sonnet 3 Audio Processor for Optimal Hearing

Shots: The US FDA has approved the Sonnet 3 audio processor for MED-EL cochlear implants; commercially available in early 2025. Also, Pts implanted with MED-EL as of Sep 1, 2024, can access one-time exchange for Sonnet 3 in the TechSwap Program Sonnet 3 is 2g lighter & ~18% shorter than Sonnet 2 with features…

ByRidhi RastogiFebruary 18, 2025

NEWS

Samsung Bioepis Reports the EC’s approval of Obodence & Xbryk (Biosimilar, Denosumab)

Shots: The EC has approved SB16: Obodence (60mg pre-filled syringe; Biosimilar: Prolia) & Xbryk (120mg vial; Biosimilar: 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 (n=168), in terms of AUC from time zero to…

ByRidhi RastogiFebruary 17, 2025

NEWS

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

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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

Ridhi Rastogi

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

The US FDA Approves MED-EL’s Sonnet 3 Audio Processor for Optimal Hearing

Samsung Bioepis Reports the EC’s approval of Obodence & Xbryk (Biosimilar, Denosumab)

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

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