Tags : Tremfya

ViewPoints Interview: Janssen’s Andrew Greenspan Shares Insights on the Data

Tuba Khan January 12, 2021

In a recent interview with PharmaShots, Andrew Greenspan, MD, VP Medical Affairs of Janssen Immunology shared his views on Janssen’s commitment to advance research in rheumatic disease. Shots: Janssen presented clinical trial results in 35 abstracts featuring findings across PsA, RA, and SLE at ACR Convergence 2020 Virtual Scientific Program Sixteen abstracts focus on Tremfya […]Read More

Regulatory

Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in

Tuba Khan November 26, 2020

Shots: The approval is based on P-lll DISCOVER-1 & -2 study assessing Tremfya (100mg q4w and q8w) vs PBO in 381 & 739 patients with active PsA who had an inadequate response to SOC & Who were biologic-naïve only and had an inadequate response to SOC respectively Combined results: achieved 1EPs of ACR20 @24wks.; improvements […]Read More

Regulatory

Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to

Tuba Khan October 19, 2020

Shots: The CHMP’s positive opinion is based on P-III DISCOVER-1 & -2 studies assessing guselkumab (100 mg, q4w/q8w) vs PBO in 381 & 739 patients with active PsA & patients who were biologic-naïve only & who had an inadequate response to standard therapies respectively Combined results: @24wks. improvement in ACR (20%); improvements in quality of […]Read More

Clinical Trials

Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of

Tuba Khan October 12, 2020

Shots: The P-II GALAXI 1 study involves assessing of Tremfya vs PBO in patients with mod. to severely active CD with intolerance to conventional therapies. In interim analyses, patients were randomized equally into 5 arms, with Tremfya (200/600/1200 mg (IV) @0, 4 & 8wks. respectively or with ustekinumab, dosed at ~6mg/kg (IV) @0wk. and dosed […]Read More

Biotech Regulatory

Janssen’s Tremfya (guselkumab) Receives the US FDA’s Approval as the

Tuba Khan September 11, 2020

Shots: The approval is based on two pivotal P-III clinical trials (DISCOVER-1 and DISCOVER-2) assessing Tremfya (100 mg, SC, q8w) following two starter doses @0 & 4wks. vs PBO in 1,120 adults with active PsA who had an inadequate response to standard therapies. Tremfya is the 1st and only biologic approved for PsA to improve […]Read More

Biotech

Janssen Reports Results of Tremfya (guselkumab) in P-III DISCOVER Studies

Tuba Khan November 12, 2019

Shots: The P-III DISCOVER 1 & 2 studies involves assessing of Tremfya (q4w/q8w, SC) vs PBO in 381 & 739 patients with active psoriatic arthritis including those previously treated with biologic anti-TNF alpha agent respectively Collective Results: @24wks. met its 1EPs of ACR20 (59%/52% & 64% vs 22% & 33%); patients with ≥3BSA affected with […]Read More

Biotech Regulatory

Janssen Reports Submission of sBLA to the US FDA for

Tuba Khan September 17, 2019

Shots: The sBLA is based on two P-III DISCOVER-1 & 2 studies assessing Tremfya (SC) in 381 & 739 patients with active PsA including prior treated patients with anti-TNF therapy and continued through 52wks. & biologic-naïve patients planning to continue through 100wks. respectively The P-III DISCOVER-1 & 2 studies resulted in meeting their 1EPs i.e, […]Read More

Biotech

Janssen Reports Results of Tremfya (guselkumab) in Two P-III DISCOVER

Tuba Khan June 17, 2019

Shots: The P-III DISCOVER 1 & 2 studies results involve assessing of Tremfya vs PBO in 381 & 739 patients with PsA prior treated with anti-TNF biologics & bio-naive candidates respectively The P-III DISCOVER 1 & 2 studies resulted in meeting its 1 EPs @24wks. i.e, improvement in ACR20, no new safety signals are observed […]Read More

Regulatory

Janssen’s Tremfya (guselkumab) Receives FDA’s Approval for Moderate-to-Severe Plaque Psoriasis

Vartika Singh February 28, 2019

Shots: The approval is based on P-III study results assessing Tremfya (guselkumab, 100mg) vs PBO in 78 patients with moderate-to-severe plaque psoriasis P-III ORION study: IGA score of 0/1 or PASI 90 @16wks. (81%, 76% vs 0%,0%); IGA score of 0 @16 wk (56% vs 0%); PASI 100 response @16 wks (50% vs 0%) Tremfya […]Read More

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Boehringer Ingelheim and MD Anderson Expand their Collaboration to Accelerate Targeted Therapies for Lung Cancer

Spark Therapeutics Signs an Option Agreement with Senti Bio to Develop Precision Gene Therapies

BMS and PsiOxus Therapeutics Expand their 2016 Immuno-Oncology Collaboration

Prestige Biopharma and Pharmapark Sign an Exclusive License and Supply Agreement to Commercialize HD204 (biosimilar, bevacizumab) in Russia

PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab

J&J Pauses Dosing of COVID-19 Vaccine Due to Blood Clotting

AstraZeneca’s Farxiga (dapagliflozin) Fails to Meet its Primary Endpoint in P-III DARE-19 Trial for COVID 19

Janssen’s Darzalex (daratumumab, SC) Combination Regimen Receives Health Canada’s Approval for Patients with Newly Diagnosed Light Chain Amyloidosis

Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Lilly and Incyte Report Results of Baricitinib in P-III BRAVE-AA1 Study for Severe Alopecia Areata

Biogen and Eisai Report Results of Lecanemab (BAN2401) in P-IIb Study 201 for Patients with Early Alzheimer Disease

Tags : Tremfya

ViewPoints Interview: Janssen’s Andrew Greenspan Shares Insights on the Data

Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in

Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to

Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of

Janssen’s Tremfya (guselkumab) Receives the US FDA’s Approval as the

Janssen Reports Results of Tremfya (guselkumab) in P-III DISCOVER Studies

Janssen Reports Submission of sBLA to the US FDA for

Janssen Reports Results of Tremfya (guselkumab) in Two P-III DISCOVER

Janssen’s Tremfya (guselkumab) Receives FDA’s Approval for Moderate-to-Severe Plaque Psoriasis

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ViewPoints Interview: Biogen’s Monica Mann Shares Insight on Plegridy to Treat Multiple Sclerosis

Lilly and Incyte Report Results of Baricitinib in P-III BRAVE-AA1 Study for Severe Alopecia Areata

Janssen’s Darzalex (daratumumab, SC) Combination Regimen Receives Health Canada’s Approval for Patients with Newly Diagnosed Light Chain Amyloidosis

Biogen and Eisai Report Results of Lecanemab (BAN2401) in P-IIb Study 201 for Patients with Early Alzheimer Disease

Tags : Tremfya

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