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J&J
NEWS

Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias

Shots: The CE mark of Thermocool Smarttouch SF Catheter for cardiac arrhythmias was based on SmartfIRE trial in European patients with refractory PAF that depicted 100% acute success rate & first-pass isolation achievement in 96.8% of veins (published in Apr 2024). The Trupulse Generator hardware compatibility is anticipated in H1’25 The company has concluded…
January 13, 2025

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J&J
NEWS

Johnson & Johnson Reports the US FDA’s BLA Acceptance of Nipocalimab with Priority Review for Generalized Myasthenia Gravis (gMG)

Shots: The US FDA has accepted & granted priority review to the BLA of nipocalimab for treating patients with antibody positive (anti-AChR, anti-MuSK, anti-LRP4) gMG, based on P-III (Vivacity-MG3) trial. MAA in this indication has been filed with the EMA on Sep 11, 2024 The P-III study assessed safety & efficacy of nipocalimab +…
January 10, 2025

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Johnson& Johnson
NEWS

Johnson & Johnson Reports the EC’s Approval of Rybrevant (Amivantamab) Plus Lazcluze (Lazertinib) as a 1L Treatment of EGFRm NSCLC 

Shots:      The EC has approved Rybrevant + Lazcluze as a 1L treatment of advanced NSCLC harboring EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution mutations. The EC’s decision of lazertinib for the corresponding combination regimen is pending (was granted CHMP’s recommendation last month)  Approval was based on P-III (MARIPOSA) trial assessing Rybrevant +…
December 30, 2024

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Johnson& Johnson
NEWS

Johnson & Johnson’s Rybrevant Plus Lazcluze Receives the CHMP’s Positive Opinion as a 1L Treatment of EGFR-Mutated NSCLC

  Shots:      The CHMP has recommended Rybrevant + Lazcluze as a 1L treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and approval of Type II extension of indication for amivantamab  Opinion was based on the P-III (MARIPOSA) study assessing Rybrevant + Lazcluze vs osimertinib & Lazcluze in NSCLC patients…
November 15, 2024

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Insights+: EMA Marketing Authorization of New Drugs in August 2024
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in August 2024

Shots:    The EC has approved to 5 Biologics and 3 New Chemical Entities in August 2024, leading to treatments for patients and advances in the healthcare industry   The major highlighted drugs were Johnson & Johnson’s Balversa to treat Metastatic Urothelial Carcinoma (mUC) and Takeda’s Adzynma for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)  PharmaShots has compiled a list…
September 24, 2024

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Johnson& Johnson
NEWS

Johnson & Johnson’s Balversa (Erdafitinib) Receives the EC’s Approval to Treat Urothelial Carcinoma 

Shots:    The EC has approved Balversa (oral, QD) monotx. for treatment-experienced adults with inoperable or metastatic urothelial carcinoma (mUC) having susceptible FGFR3 genetic alterations  Approval was supported by results of cohort 1 from the P-III (THOR) trial assessing the safety & effectiveness of Balversa (n=136) vs CT (n=130) to treat mUC with select FGFR alterations…
August 23, 2024

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J&J
NEWS

Johnson & Johnson Reports the US FDA’s Approval of Rybrevant + Lazcluze as a 1L Treatment of NSCLC with EGFR Mutations 

Shots:     The US FDA has approved J&J’s Rybrevant + Lazcluze as a 1L treatment for LA/metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations  The approval was based on the P-III (MARIPOSA) assessing Rybrevant + lazertinib vs osimertinib and lazertinib alone in 1074 patients  The study reached its 1EP and 2EPs…
August 19, 2024

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Insights + EMA Marketing Authorization of New Drugs in July 2024
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in July 2024

Shots:    The EMA granted Positive Opinion to 2 Biologics and 5 New Chemical Entities in July 2024, leading to treatments for patients and advances in the healthcare industry   The major highlighted drugs were Johnson & Johnson’s Yuvanci to treat Pulmonary Arterial Hypertension (PAH) and Astellas’ Vyloy + CT for Gastric & Gastroesophageal Junction Cancer   PharmaShots has compiled a list…
August 14, 2024

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