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Total 27 results found since Jan 2013.
New STELARA ® (ustekinumab) Long-Term Data Support its Established Safety Profile in Inflammatory Bowel Disease and Durable Efficacy in Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, March 4, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final pooled long-term safety results for STELARA® (ustekinumab) through five years in adults with moderately to severely active Crohn’s disease (CD) and four years in adults with moderately to severely active ulcerative colitis (UC), as well as final four-year clinical and endoscopic outcomes from the UNIFI long-term extension (LTE) study evaluating the efficacy of STELARA for the treatment of adults with moderately to severely active UC.1,2 These data are a part of Janssen’s 22 oral and poster ...
Source: Johnson and Johnson - March 4, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
U.S. weighs crackdown on experiments that could make viruses more dangerous
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Source: ScienceNOW - October 19, 2022 Category: Science Source Type: news
STELARA ® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults with Moderately to Severely Active Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final data from the long-term extension (LTE) of the Phase 3 UNIFI study demonstrating efficacy and safety of STELARA® (ustekinumab) through four years of treatment in adult patients with moderately to severely active ulcerative colitis (UC).1 Among all patients who had achieved clinical responsea with STELARA during induction, 64.9 percent were in symptomatic remissionb after 44 weeks of maintenance. At week 200 (four years), this proportion of patients was 55.2 percent; the majority (96.4 percen...
Source: Johnson and Johnson - October 10, 2022 Category: Pharmaceuticals Source Type: news
Anthony Fauci, loved and hated, plots his next move: ‘I'm not going to sit in my house’
In 1984, when Anthony Fauci took over as head of the National Institute of Allergy and Infectious Diseases (NIAID), his wife gave him a plant for the new office. Both the palm and the 81-year-old physician are still there, the giant plant now crowding the office of one of the most celebrated—and polarizing—scientific figures in U.S. history. But not for much longer. Fauci announced on 22 August that he would step down at the end of the year from both NIAID and his post as the chief medical adviser to President Joe Biden.
“What am I going to do with this plant? It’s a monster. I can’t fit it in any other plac...
Source: ScienceNOW - September 1, 2022 Category: Science Source Type: news
Anthony Fauci, loved and hated, plots his next move: ‘I’m not going to sit in my house’
In 1984, when Anthony Fauci took over as head of the National Institute of Allergy and Infectious Diseases (NIAID), his wife gave him a plant for the new office. Both the palm and the 81-year-old physician are still there, the giant plant now crowding the office of one of the most celebrated—and polarizing—scientific figures in U.S. history. But not for much longer. Fauci announced on 22 August that he would step down at the end of the year from both NIAID and his post as the chief medical adviser to President Joe Biden.
“What am I going to do with this plant? It’s a monster. I can’t fit it in any other plac...
Source: ScienceNOW - September 1, 2022 Category: Science Source Type: news
PAN-TB Collaboration to Advance Investigational Tuberculosis Drug Regimens to Phase 2 Clinical Trials
August 17, 2022 – The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration announced today the execution of a joint development agreement (JDA) supporting the progression of two investigational tuberculosis (TB) combination treatment regimens into phase 2 clinical development. The collaboration will evaluate whether the novel regimens, which combine registered products and new chemical entities (NCEs), can effectively treat all forms of active pulmonary TB using substantially shorter treatment durations than existing drug regimens, with the goal of identifying a regimen suitable for phase 3 develo...
Source: Johnson and Johnson - August 17, 2022 Category: Pharmaceuticals Source Type: news
STELARA ® (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis
HORSHAM, PENNSYLVANIA, August 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) for the treatment of pediatric patients six years of age and older with active psoriatic arthritis (PsA). This rare disease that resembles adult PsA affects five to eight percent of children and adolescents with chronic inflammatory arthritis.*1-7 Two of the four indications for STELARA now include pediatric patients, further expanding its treatment profile since the first approval in 2009 for adults living with moderate...
Source: Johnson and Johnson - August 1, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA ® (guselkumab) and Long-Term Safety Profile for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022
SPRING HOUSE, PENNSYLVANIA, May 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 2 GALAXI 1 clinical trial of TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), and from three separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with STELARA® (ustekinumab).1,2,3,4 These data are being presented as oral and poster presentations and are among 29 Janssen abstracts presented during the Digestive Disease Week® (DDW) meeting taking place in person and virtually in San Di...
Source: Johnson and Johnson - May 24, 2022 Category: Pharmaceuticals Source Type: news
Janssen Reports Positive Topline Week 48 Phase 2 Results for TREMFYA ® (guselkumab) in Adults With Moderately to Severely Active Crohn's Disease
SPRING HOUSE, PENNSYLVANIA, November 17, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced topline results from the Phase 2 GALAXI 1 clinical trial which showed rates of clinical remission (Crohn’s Disease Activity Index [CDAI]<150) previously reported at week 12 increased at week 48 among adults with moderately to severely active Crohn’s disease (CD) treated with TREMFYA® (guselkumab).1 At week 48, 65 percent of patients receiving TREMFYA achieved clinical remission. TREMFYA is under investigation and not currently approved for the treatment of CD in the U.S.2Janssen previously...
Source: Johnson and Johnson - November 17, 2021 Category: Pharmaceuticals Source Type: news
New Analyses Suggest Favorable Results for STELARA ® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 25, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).1,2 In a modelled analysisa focused on treatment sequencing using data from randomized controlled trials, network meta-analysis and literature, results showed patient time spent in clinical remission or response was highest when STELARA was used as a first-line advanced therapy for bio-naïve patients with moderately to severely acti...
Source: Johnson and Johnson - October 25, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Submits Application Seeking U.S. FDA Approval of STELARA ® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis
HORSHAM, PENNSYLVANIA, October 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated dis...
Source: Johnson and Johnson - October 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA ® (ustekinumab) in Older Patients Across Approved Indications
SPRING HOUSE, PENNSYLVANIA, October 4, 2021 – Today, the Janssen Pharmaceutical Companies of Johnson & Johnson announced a new analysis of STELARA® (ustekinumab) pooled safety data from 13 clinical studies across approved indications, showing rates of key safety events among adults 60 years and older treated with STELARA for up to five yearsa were similar to rates observed with placebo during the control phase of these trials.1,b Approved indications included adults with moderately to severely active Crohn’s disease (CD), moderately to severely active ulcerative colitis (UC), moderate to severe plaque psoriasis (P...
Source: Johnson and Johnson - October 4, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Mind the gap from research laboratory to clinic: Challenges and opportunities for next-generation assays in human diseases
Vaccine. 2021 Aug 5:S0264-410X(21)00964-6. doi: 10.1016/j.vaccine.2021.07.071. Online ahead of print.ABSTRACTModern vaccinology has experienced major conceptual and technological advances over the past 30 years. These include atomic-level structures driving immunogen design, new vaccine delivery methods, powerful adjuvants, and novel animal models. In addition, utilizing advanced assays to learn how the immune system senses a pathogen and orchestrates protective immunity has been critical in the design of effective vaccines and therapeutics. The National Institute of Allergy and Infectious Diseases of the National Institut...
Source: Vaccine - August 9, 2021 Category: Allergy & Immunology Authors: M Patricia D'Souza Amy C Palin Thomas Calder Hana Golding Steven H Kleinstein Erin L Milliken David O'Connor Georgia Tomaras Jon Warren Cesar Boggiano Source Type: research
STELARA ® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Rates in Adults with Moderately to Severely Active Ulcerative Colitis at Nearly Three Years in Long-Term Extension of Phase 3 Trial
SPRING HOUSE, PENNSYLVANIA, July 9, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new three-year data from the long-term extension (LTE) of the STELARA® (ustekinumab) Phase 3 UNIFI study. The data demonstrated the majority (55.2 percent) of adult patients with moderately to severely active ulcerative colitis (UC) who initially responded to treatment with STELARA sustained symptomatic remissiona rates at nearly three years (week 152).1 Furthermore, a majority (96.4 percent) of the patients in symptomatic remissiona at week 152 were corticosteroid-free. These data are being presented...
Source: Johnson and Johnson - July 9, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
