Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

Shots: The EC has approved label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT Approval was backed by P-III (PALOMA-3) trial, evaluating non-inferiority of…

ByRidhi RastogiApril 9, 2025

NEWS

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat NDMM pts; sBLA under the US FDA’s review Approval was based on P-III (CEPHEUS) trial assessing D-VRd (n=197) vs VRd (n=198) in 395 ASCT-ineligible or deferred pts, in 13 countries across the EU, North & South America At 59mos. mFU, trial…

ByRidhi RastogiApril 8, 2025

NEWS

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

Shots: J&J has reported P-IIIb (APEX) trial data assessing Tremfya vs PBO in biologic-naïve PsA pts with inadequate response to standard therapies for 24wks., followed by a 12wk. safety follow-up; eligible pts could enter a 2yr. extension phase prior to the final safety follow-up Trial met its 1EP of improved ACR20 response, showing reduced signs…

ByRidhi RastogiApril 7, 2025

NEWS

Johnson & Johnson Reports P-III (MARIPOSA) Trial Data of Rybrevant + Lazcluze for EGFRm NSCLC

Shots: J&J reported P-III (MARIPOSA) trial data assessing Rybrevant + Lazcluze vs osimertinib or Lazcluze alone as a 1L treatment of locally advanced or metastatic NSCLC pts (n=1074) with EGFR ex19del or L858R substitution mutations At 37.8mos. mFU, trial showed superior OS, with mOS not reached vs 36.7mos. for osimertinib-treated pts, plus 56% vs 44%…

ByRidhi RastogiApril 2, 2025

NEWS

Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025

Shots: J&J has reported P-III trial data incl. ICONIC-LEAD (vs PBO) & ICONIC-ADVANCE 1&2 (vs Sotyktu) assessing icotrokinra (JNJ-2113, QD, PO) to treat mod. to sev. plaque Ps OICONIC-LEAD showed that pts achieved IGA 0/1 (65% vs 8%) & reached PASI 90 (50% vs 4%) at 16wks. By Wk. 24, 74% achieved IGA 0/1,…

ByRidhi RastogiMarch 10, 2025

NEWS

Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the US

Shots: Shockwave Medical (J&J MedTech’s company) has launched Shockwave Javelin peripheral IVL catheter in the US to modify calcium & cross extremely narrowed vessels in pts with peripheral artery disease (PAD) Shockwave Javelin was studied in FORWARD PAD IDE trial that demonstrated similar safety & effectiveness compared to balloon-based Shockwave IVL catheters, regardless of…

ByRidhi RastogiMarch 6, 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

VIEWPOINTS

Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

Shots: Johnson & Johnson’s (J&J) Tremfya recently received its third approval from the US FDA, supported by the pivotal QUASAR study, which demonstrated significant remission after one year of treatment in adults with moderately to severely active ulcerative colitis Tremfya is a dual-binding monoclonal antibody targeting interleukin 23 (IL-23), a cytokine responsible for inflammation At…

BySaurabh ChaubeyFebruary 3, 2025

NEWS

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

Shots: The US FDA has approved sNDA for Spravato CIII nasal spray to treat MDD patients unresponsive to at least two oral antidepressants, following the FDA Priority Review Approval was based on a multicenter trial that assessed Spravato vs PBO, showing an improved MADRS total score. In a post-hoc analysis, Spravato improved all 10…

ByRidhi RastogiJanuary 22, 2025

NEWS

Johnson & Johnson Submits NDA to the US FDA for TAR-200 to Treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC)

Shots: FDA received NDA of TAR-200 (J&J) for the treatment of Bacillus Calmette-Guérin (BCG) -unresponsive HR-NMIBC with CIS &/or papillary tumors the application will be reviewed under RTOR pathway, following receipt of BTD in Dec 2023 The NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in patients ineligible or opting out of…

ByRidhi RastogiJanuary 17, 2025

Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis

Johnson & Johnson Reports P-III (MARIPOSA) Trial Data of Rybrevant + Lazcluze for EGFRm NSCLC

Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025

Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the US

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

Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

Johnson & Johnson Submits NDA to the US FDA for TAR-200 to Treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC)

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