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Mashup Score: 0Johnson & Johnson to Resume U.S. VARIPULSE™ Cases - 15 day(s) ago
Investigation found that VARIPULSE™ devices operate as intended Cases being performed in U.S. External Evaluation to resume and Instructions for Use to be updated
Source: www.jnj.comCategories: General Medicine News, Hem/OncsTweet
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Mashup Score: 70CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer - 1 month(s) ago
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous thromboembolic events1 CHMP has issued a positive opinion for an extension of marketing authorisation for subcutaneous amivantamab dosed every two weeks
Source: www.jnj.comCategories: General Medicine News, Hem/OncsTweet-
🔑 🇪🇺 #PressRelease EMA CHMP recommends subcutaneous amivantamab (Q2W) for the treatment of patients with advanced EGFR-mutated NSCLC (MARIPOSA & PAPILLON)🪢 #LCSM https://t.co/prOXYmICZT
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Mashup Score: 69CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer - 1 month(s) ago
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous thromboembolic events1 CHMP has issued a positive opinion for an extension of marketing authorisation for subcutaneous amivantamab dosed every two weeks
Source: www.jnj.comCategories: General Medicine News, Hem/OncsTweet-
🔑 🇪🇺 #PressRelease EMA CHMP recommends subcutaneous amivantamab (Q2W) for the treatment of patients with advanced EGFR-mutated NSCLC (MARIPOSA & PAPILLON)🪢 #LCSM https://t.co/prOXYmICZT
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Mashup Score: 9
Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care osimertinib1 Median overall survival improvement is expected to exceed one year1
Source: www.jnj.comCategories: General Medicine News, Hem/OncsTweet-
Today, we’re one step closer to transforming care for EGFRm #NSCLC. I’m excited to share that the European Commission has now fully approved our chemo-free regimen—a breakthrough that offers a new way forward for patients and their families across the EU: https://t.co/MKWoZbODzj https://t.co/8rcmu90Gdr
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Mashup Score: 29
Median overall survival improvement expected to exceed one year First and only regimen with a survival benefit over current standard of care in first-line treatment of EGFR-mutated lung cancer
Source: www.jnj.comCategories: General Medicine News, Hem/OncsTweet-
Proud to share a topline overall survival announcement from the Phase 3 MARIPOSA trial in EGFR-mutated #NSCLC. These data reinforce @JNJInnovMed’s dedication to help transform what’s possible in cancer care and potentially give patients more time and hope: https://t.co/Ug1aHpoqJP https://t.co/jrKUaLTurl
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Mashup Score: 29
Median overall survival improvement expected to exceed one year First and only regimen with a survival benefit over current standard of care in first-line treatment of EGFR-mutated lung cancer
Source: www.jnj.comCategories: General Medicine News, Hem/OncsTweet-
Proud to share a topline overall survival announcement from the Phase 3 MARIPOSA trial in EGFR-mutated #NSCLC. These data reinforce @JNJInnovMed’s dedication to help transform what’s possible in cancer care and potentially give patients more time and hope: https://t.co/Ug1aHpoqJP https://t.co/jrKUaLTurl
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Mashup Score: 29
Median overall survival improvement expected to exceed one year First and only regimen with a survival benefit over current standard of care in first-line treatment of EGFR-mutated lung cancer
Source: www.jnj.comCategories: General Medicine News, Hem/OncsTweet-
Proud to share a topline overall survival announcement from the Phase 3 MARIPOSA trial in EGFR-mutated #NSCLC. These data reinforce @JNJInnovMed’s dedication to help transform what’s possible in cancer care and potentially give patients more time and hope: https://t.co/Ug1aHpoqJP https://t.co/jrKUaLTurl
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Mashup Score: 37Update on U.S. regulatory review of subcutaneous amivantamab - 3 month(s) ago
Sorry, I don’ t understand. Please try again Update on U.S. regulatory review of subcutaneous amivantamab RARITAN, N.J., December 16, 2024 – Johnson & Johnson (NYSE:JNJ) today announced the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) in patients with non-small cell lung cancer (NSCLC) with epidermal
Source: www.jnj.comCategories: General Medicine News, Hem/OncsTweet-
Will have to wait a bit longer for subcutaneous amivantamab. FDA issues complete response letter to application - not based on efficacy or safety, rather related to “observations as part of a standard pre-approval inspection at a manufacturing facility.” https://t.co/KcL7fPRVKI
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Mashup Score: 35Update on U.S. regulatory review of subcutaneous amivantamab - 3 month(s) ago
Sorry, I don’ t understand. Please try again Update on U.S. regulatory review of subcutaneous amivantamab RARITAN, N.J., December 16, 2024 – Johnson & Johnson (NYSE:JNJ) today announced the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) in patients with non-small cell lung cancer (NSCLC) with epidermal
Source: www.jnj.comCategories: General Medicine News, Hem/OncsTweet-
Will have to wait a bit longer for subcutaneous amivantamab. FDA issues complete response letter to application - not based on efficacy or safety, rather related to “observations as part of a standard pre-approval inspection at a manufacturing facility.” https://t.co/KcL7fPRVKI
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Mashup Score: 0Johnson & Johnson seeks U.S. FDA approval for first pediatric indications for TREMFYA® (guselkumab) - 3 month(s) ago
Applications filed for TREMFYA® to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic arthritis
Source: www.jnj.comCategories: General Medicine News, General HCPsTweet-
J&J has submitted 2 supplemental BLAs applying for FDA approval of guselkumab( Tremfya) for use in juvenile plaque psoriasis & juvenile (>5-6 yrs age) psoriatic arthritis based on several phase 3 RCTs. https://t.co/dAkH219pzN https://t.co/R9yJCSOVJa
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