OPSYNVI ® (macitentan and tadalafil) Becomes the First and Only Health Canada-Approved Once Daily Fixed Dose Combination Treatment for Patients with Pulmonary Arterial Hypertension (PAH)
Toronto, ON, (October 15, 2021) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada approved OPSYNVI® (macitentan 10mg and tadalafil 40mg) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose PAH is idiopathic, heritable, or associated with connective tissue disease or congenital heart disease.OPSYNVI® should be used in patients who are currently treated concomitantly with stable doses of macitentan 10mg and tadalafil 40mg (20mg x 2) as sepa...
Source: Johnson and Johnson - October 15, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Showcases Commitment to Advancing Scientific Innovation in Pulmonary Arterial Hypertension (PAH) at CHEST 2021 Annual Meeting
TITUSVILLE, N.J. – October 14, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today 11* abstracts highlighting data from its pulmonary hypertension (PH) portfolio will be presented at CHEST 2021, the annual meeting of the American College of Chest Physicians, held virtually October 17-20.Data presentations from eight abstracts will provide additional evidence supporting the role of objective multiparameter risk assessment approaches in helping to optimize treatment and care for pulmonary arterial hypertension (PAH), as well as the impact of earlier and comprehensive therapy with UPTRAVIÂ...
Source: Johnson and Johnson - October 14, 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
Janssen Announces Novel Mechanism of Action that Shows Promise Against Dengue in Data Published in Nature
BEERSE, BELGIUM, October 6, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced today, in collaboration with the KU Leuven Rega Institute and the KU Leuven Centre for Drug Design and Discovery (CD3), the publication of new preclinical data in the journal Nature showing that an early-stage compound with a novel mechanism of action could potentially treat all serotypes of dengue fever and provide a period of protection against acquiring the dengue virus. Janssen is now moving its dengue program into clinical development. Data from the early-stage study suggest that an antiviral compound...
Source: Johnson and Johnson - October 6, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine
NEW BRUNSWICK, N.J., October 05, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) announced it has submitted data to the U.S. Food and Drug Administration (FDA) to support use of a booster shot of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older.The submission includes recent results from the Phase 3 ENSEMBLE 2 study that found a booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%) and 100 percent protection (CI, 33%-100%) again...
Source: Johnson and Johnson - October 5, 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
Janssen Announces Phase 2b Data Demonstrating its Investigational RSV Adult Vaccine Provided 80% Protection against Lower Respiratory Infections in Older Adults
RARITAN, N.J., October 2, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that its investigational respiratory syncytial virus (RSV) vaccine candidate was highly effective in protecting against lower respiratory tract disease (LRTD) caused by RSV, demonstrating vaccine efficacy of 80 percent (CI, 52.2-92.9%) in adults aged 65 and older. The study results were presented as a late-breaking abstract at the virtual IDWeek 2021 conference on October 2.“The findings from our CYPRESS study are very encouraging as we seek to deliver a long-awaited preventive vaccine to stave off the severe ...
Source: Johnson and Johnson - October 2, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults
RARITAN, N.J., September 29, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the initiation of its Phase 3 EVERGREEN study. The study will evaluate the efficacy, safety and immunogenicity of Janssen’s investigational adult vaccine against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV), when compared with placebo in approximately 23,000 adults aged 60 years and older throughout North America and a selection of countries across Europe, Asia and the Southern Hemisphere.The EVERGREEN study was initiated based on positive results from the Phase 2b CYPR...
Source: Johnson and Johnson - September 29, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO ® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events
RARITAN, NJ, September 27, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data from the Phase 3 UNIVERSE study showing treatment with XARELTO® (rivaroxaban) in an oral suspension formulation, compared to treatment with aspirin, was associated with numerically fewer blood clots and clinical events strongly associated with blood clots in pediatric patients (aged 2-8 years) who have undergone the Fontan procedure. [1] These findings, which were published this month in the Journal of the American Heart Association and included in a recent New Drug Application submitted to the U.S. F...
Source: Johnson and Johnson - September 27, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Side effects from too much erectile dysfunction medication - 'I wouldn't advise it'
ERECTILE dysfunction medication tends to work by increasing blood flow to the penis to help men get an erection. Sildenafil is a medicine used to treat erectile dysfunction, with one of the more well known forms being Viagra. You can get sildenafil on the NHS if you have erectile dysfunction or pulmonary hypertension, but it is also available without a prescription. (Source: Daily Express - Health)
Source: Daily Express - Health - September 26, 2021 Category: Consumer Health News Source Type: news
Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.
This study compared approximately 390,000 people who received the Company’s single-shot COVID-19 vaccine versus approximately 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code, and comorbidities and predictors for COVID-19 infection severity.This study is a longitudinal cohort design, using robust propensity matching methods to create a comparator cohort to assess real-world VE. All analyses were performed using the Aetion Evidence Platform, which is a scientifically validated software that is also used by regulators, payers, and health technology assessment bodies to assess the safety, eff...
Source: Johnson and Johnson - September 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Data on RYBREVANT ® (amivantamab-vmjw) in Combination with Lazertinib Show Early Activity in Patients with Non-Small Cell Lung Cancer Whose Disease Has Progressed After Both Osimertinib and Platinum-Based Chemotherapy
September 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary results from the Phase 1b CHRYSALIS-2 (NCT04077463) study evaluating RYBREVANT® (amivantamab-vmjw) in combination with lazertinib in the treatment of patients with non-small cell lung cancer (NSCLC) characterized by epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations whose disease had progressed after treatment with osimertinib and platinum chemotherapy.[i] While previously reported results have demonstrated durable responses with RYBREVANT® in combination with lazertini...
Source: Johnson and Johnson - September 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
RYBREVANT ® (amivantamab-vmjw) Provides Higher Activity and Longer Duration of Response When Used in Combination with Lazertinib in Patients with Advanced EGFR-Mutant Non-Small Cell Lung Cancer Who Have Failed Osimertinib
September 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced a new analysis from the CHRYSALIS (NCT02609776) study evaluating RYBREVANT® (amivantamab-vmjw) monotherapy and a combination regimen with lazertinib in advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations who progressed after osimertinib.[1] The analysis showed higher activity and longer duration of response (DOR) in patients treated with the combination therapy, demonstrating the potential benefit of targeting the extracellular (outer) and catalytic (i...
Source: Johnson and Johnson - September 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Presents Results from Phase 1b/2 NORSE Study in Patients with Metastatic or Locally Advanced Urothelial Carcinoma Treated with BALVERSA ® (erdafitinib) in Combination with Cetrelimab, a PD-1 Inhibitor
September 17, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1b/2 NORSE (NCT03473743) study evaluating BALVERSA® (erdafitinib) in combination with cetrelimab, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody, compared to BALVERSA® monotherapy in patients with locally advanced or metastatic urothelial carcinoma (mUC) with fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations who are ineligible for cisplatin, a current standard of care treatment for mUC. The results were highlighted in an oral presentation at t...
Source: Johnson and Johnson - September 17, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Ebola Vaccine Regimen Demonstrated Robust and Durable Immune Response in Adults and Children in Data Published in The Lancet Infectious Diseases
NEW BRUNSWICK, N.J., September 13, 2021 – Data from two papers published in The Lancet Infectious Diseases demonstrated that the Johnson & Johnson (the Company) Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo), generated robust humoral (antibody) immune responses in adults and children (ages 1-17) with the immune responses persisting in adults for at least two years. The data also showed that booster vaccination with Ad26.ZEBOV, administered to adults two years after the initial vaccination, induced a strong anamnestic (immune) response within seven days. These findings support the potential p...
Source: Johnson and Johnson - September 13, 2021 Category: Pharmaceuticals Source Type: news
