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 mutationsAt 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 colitisTremfya is a dual-binding monoclonal antibody targeting interleukin 23 (IL-23), a cytokine responsible for inflammationAt…

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

TOP 20

Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

Shots:Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versionsLike every other utility patent, pharmaceuticals also get market exclusivity of 20 years. Some companies accept the offered period and open doors to biological drugs or biosimilars. In…

ByPrince GiriMarch 29, 2023

INSIGHTS+

Top Performing Drug of 2021 – Imbruvica (January Edition)

Active Ingredient: Ibrutinib Dosage Forms & Strengths: Capsules: 70 mg and 140 mg Tablets: 140 mg, 280 mg, 420 mg, and 560 mg Mechanism of Action: Bruton's tyrosine kinase Inhibitor (BTKi) First Approval: US (13 Nov 2013), EU (Oct 2014)  Revenue AnalysisImbruvica is an oral therapy that inhibits a protein called Bruton's tyrosine kinase. Imbruvica was one…

BySenior EditorJanuary 25, 2023

TOP 20

Top 20 Medical Device Companies Based on 2021 Revenue

Despite the severe impact of the Covid-19 pandemic in 2020, the medical device market continued to emerge with patients' more significant needs and emerging diseases In 2021, the medical device markets continued to supply personal protective equipment for the pandemic and new technological developments. Medtronic remains at the top of the ledger with total revenue…

ByPrince GiriMay 12, 2022

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)

Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

Top Performing Drug of 2021 – Imbruvica (January Edition)

Top 20 Medical Device Companies Based on 2021 Revenue

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