Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
NEW BRUNSWICK, N.J., October 15, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine. The vote was based on findings from two Company clinical trials, including the Phase 3 ENSEMBLE 2 study, which evaluated a booster dose of the Johnson &...
Source: Johnson and Johnson - October 15, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

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 ...
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 ...
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 associa...
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 comp...
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%) a...
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 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...
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...
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...
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,...
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...
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 catal...
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 present...
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 p...
Source: Johnson and Johnson - September 13, 2021 Category: Pharmaceuticals Source Type: news

ERLEADA ® (apalutamide) Oral Presentations Demonstrate Importance of Prostate Specific Antigen (PSA) as Key Efficacy Indicator and Show Strong Patient Adherence Rates
September 11, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data demonstrating robust prostate-specific antigen (PSA) response and strong adherence rates in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with ERLEADA® (apalutamide) in the real-world clinical setting. The strong PSA response was also seen in a separate post-hoc analysis that showed a correlation between rapid and deep PSA response and prolonged survival in both metastatic castration-sensitive prostate cancer (mCSPC) and nmCRPC. The post-hoc analysis also...
Source: Johnson and Johnson - September 12, 2021 Category: Pharmaceuticals Source Type: news

Janssen Demonstrates Commitment to Advancing Science and Innovation in the Treatment of Solid Tumors at ESMO Annual Congress
September 8, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than ten data presentations from its lung cancer, bladder cancer and prostate cancer portfolio and pipeline will be featured during the European Society for Medical Oncology (ESMO) Annual Congress 2021 virtual meeting, September 16–21. Further details about these data and the science Janssen is advancing will be made available throughout ESMO via the Janssen Oncology Virtual Newsroom.“With a diverse oncology portfolio and pipeline spanning bladder cancer, lung cancer and prostate can...
Source: Johnson and Johnson - September 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces U.S. FDA Approval of INVEGA HAFYERA ™(6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults with Schizophrenia
TITUSVILLE, N.J., Sept. 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Before transitioning to INVEGA HAFYERA™, patients must be adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least four months, or INVEGA TRINZA® (3-month paliperidone palmitate) for at least one 3-month injection cycle.1 The FDA a...
Source: Johnson and Johnson - September 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Striving to Deliver Better Outcomes: Janssen to Showcase Commitment to Advancing Science for Genitourinary Cancers at AUA 2021
August 31, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today multiple company-sponsored presentations in prostate and bladder cancers will be highlighted at the virtual 2021 American Urological Association Annual Meeting (AUA 2021), September 10-13. “Janssen maintains a strong commitment to advancing innovation and new therapeutic options for patients with genitourinary malignancies. As the treatment of genitourinary cancers becomes more complex, we continue to work with urologists and their teams to improve outcomes for patients across the continuum of disease...
Source: Johnson and Johnson - August 31, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson and Global Partners Announce Results from Phase 2b Imbokodo HIV Vaccine Clinical Trial in Young Women in Sub-Saharan Africa
This study is being conducted in the Americas and Europe where different strains of HIV are circulating. Given these differentiating factors and following consultations with the Mosaico study independent Data and Safety Monitoring Board (DSMB), it was decided that the Mosaico study will continue at this time. “We are extremely grateful to the women who volunteered for the Imbokodo study, and to our partners, including the people on the frontlines, all of whom are contributing every day to this enduring quest to make HIV history,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scien...
Source: Johnson and Johnson - August 31, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Announces Data to Support Boosting its Single-Shot COVID-19 Vaccine
NEW BRUNSWICK, N.J., August 25, 2021 – Johnson & Johnson today announced data supporting the use of its COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine. In July, the Company reported interim Phase 1/2a data published in the New England Journal of Medicine that demonstrated neutralizing antibody responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization. In anticipation of the potential need for boosters, the Company conducted two Phase 1/2a studies in individuals...
Source: Johnson and Johnson - August 25, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) e...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Patients With More Severe PH in COPD May Respond to Treatment Patients With More Severe PH in COPD May Respond to Treatment
Male sex, low 6-minute walking distance, and high pulmonary vascular resistance at baseline were predictive of poorer outcomes for pulmonary hypertension and COPD.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 19, 2021 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

Janssen Presents Phase 1 Results for RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with MET Exon 14 Skipping Mutations
August 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANTTM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. The initial data showed anti-tumor activity in patients with METex14 mutations and a safety profile consistent with reported experience at the approved CHRYSALIS Phase 2 dose (RYBREVANTTM 1050 mg [
Source: Johnson and Johnson - August 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

UPTRAVI ® (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)
TITUSVILLE, N.J. – July 30, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved UPTRAVI® (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy. UPTRAVI® IV is a therapeutic option that will allow patients to avoid short-term treatment interruptions and stay on UPTRAVI® therapy, as uninterrupted treatment is considered key for individ...
Source: Johnson and Johnson - July 30, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Innovation Announces Extension Of Innovation Partnering Office at Monash University In Collaboration With Victorian State Government To Accelerate The Life-Sciences Hub
MELBOURNE, Australia, July 15, 2021 -- Johnson & Johnson Innovation announced today the extension of the Johnson & Johnson Innovation Partnering Office at Monash University's Clayton Campus in Melbourne (JJIPO@Monash) in collaboration with the Victorian State Government.This joint initiative between Johnson & Johnson Innovation, the Victorian Government and Monash University will be extended for approximately two years through June 30, 2023. The agreement will allow JJIPO@Monash to continue connecting with the Victorian innovation ecosystem, nurturing and accelerating innovative research, new product developmen...
Source: Johnson and Johnson - July 15, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

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 pr...
Source: Johnson and Johnson - July 9, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response
NEW BRUNSWICK, N.J., July 1, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. The two preprint study summaries have been submitted today to bioRxiv. “Today’s newly announced studies reinforce the ability of the Johnson & Johnson COVID-19 vaccine ...
Source: Johnson and Johnson - July 1, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Pulmonary hypertension disorders result in high costs, disability and mortality in Colombia
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - July 1, 2021 Category: Drugs & Pharmacology Source Type: news

Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with co...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Phase 3 Study Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia
Raritan, N.J., June 12, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA® plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duratio...
Source: Johnson and Johnson - June 12, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX ® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible
Raritan, N.J., June 12, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® (daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression.[1] These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefin...
Source: Johnson and Johnson - June 12, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Phase 3b Psoriatic Arthritis (PsA) Data Show First-in-Class TREMFYA ® (guselkumab) Achieved Robust Joint Symptom Improvement and Complete Skin Clearance in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR)
SPRING HOUSE, PENNSYLVANIA, June 2, 2021 – Today the Janssen Pharmaceutical Companies of Johnson & Johnson announced new efficacy and safety data for first-in-class TREMFYA® (guselkumab), including data from the first study evaluating a selective IL-23 inhibitor in adult patients with active PsA, all of whom had demonstrated inadequate response or intolerance to TNFi.1 In the COSMOS Phase 3b study, significantly higher proportions of patients treated with TREMFYA showed joint symptom improvement and complete skin clearance versus placebo at week 24 in this true TNFi-IRa patient population, which is often more...
Source: Johnson and Johnson - June 2, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 30 company-sponsored studies, including six oral presentations, will be featured during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8. Janssen presentations will include new data and updates for both approved and investigational therapeutics that are being studied for the treatment of various solid tumors and blood cancers. Immediately following ASCO, additional data will be featured during the European Hematology Association (EHA) Virtual Congress, June 9-17. A ...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma. This distinction for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors, follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) received earlier this year. Today’s BTD marks the 11th received by Janssen’s ...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). Updated results from the Phase 1b/2 CARTITUDE-1 study (n=97) with a longer-term follow-up at a median of 18 months showed an overall response rate (ORR) of 98 percent, with 80 percent of patients achieving a stringent complete response (sCR), highlight...
Source: Johnson and Johnson - June 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
RARITAN, N.J., May 26, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated results from the Phase 3 ANDROMEDA study, which evaluated DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare blood cell disorder associated with the deterioration of vital organs, most notably the heart, kidneys and liver.[1] Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEX FASPRO®...
Source: Johnson and Johnson - May 26, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Long-Term ERLEADA ® (apalutamide) Patient-Reported Outcomes Data in Metastatic Castration-Sensitive Prostate Cancer Demonstrate Maintenance of Health-Related Quality of Life for Patients
May 26, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced patient-reported outcomes (PRO) data from the pre-specified final analysis of the Phase 3 TITAN study in patients with metastatic castration-sensitive prostate cancer (mCSPC). The TITAN study previously demonstrated statistically significant improvement in overall survival (OS) after a median follow-up of 44 months in patients receiving ERLEADA® plus androgen deprivation therapy (ADT).1 The new PRO data showed that the addition of ERLEADA® to ADT maintained patients’ health-related quality of lif...
Source: Johnson and Johnson - May 26, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
May 24, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today follow-up data from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of the investigational product talquetamab, the only off-the-shelf T-cell redirecting bispecific antibody in clinical development to target both GPRC5D, a novel multiple myeloma target, and CD3 on T-cells (NCT03399799).[1],[2],[3] With a median follow-up of more than six months, updated results in 30 patients with relapsed or refractory multiple myeloma treated with talquetamab by subcutaneous (SC) administration at the recommend...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen ’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma
We reported initial findings for teclistamab at ASCO 2020, and study updates have observed a deepening of responses that have shown to be durable in a significant percentage of patients with relapsed or refractory multiple myeloma,” said Amrita Y. Krishnan, M.D., Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research and Chief, Division of Multiple Myeloma, Department of Hematology and Hematopoietic Cell Transplantation at City of Hope, and study investigator. “Teclistamab exposure was sustained across the dosing interval and exceeded target levels, and consistent T-cell activation was ob...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

European Commission approves PONVORYTM (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features
BEERSE, BELGIUM, May 24, 2021 – Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced today that the European Commission (EC) has approved PONVORY (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.[4] “Relapsing multiple sclerosis is an unpredictable and complex disease that can present very differently from individual to individual, placing a heavy burden on the patient and their loved ones,” said Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Professor of Neuro...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn ’s Disease
SPRING HOUSE, PENNSYLVANIA, May 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced efficacy and safety data for STELARA® (ustekinumab) in Crohn’s disease (CD) and ulcerative colitis (UC),1-4including data from the SEAVUE study, the first head-to-head study of biologic therapies in patients with CD, presented in a Clinical Science Late-Breaking Abstract Plenary session.1 SEAVUE data showed treatment with STELARA demonstrated high rates of clinical remission, corticosteroid-free remission, clinical response and endoscopic response through one year in biologic-naïve p...
Source: Johnson and Johnson - May 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

RYBREVANTTM (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
May 21, 2021 (HORSHAM, P.A.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of RYBREVANTTM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.[1] RYBREVANTTM is the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC t...
Source: Johnson and Johnson - May 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

IMBRUVICA ® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, First-Line Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control
May 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the fixed-duration cohort of the investigational Phase 2 CAPTIVATE study, showing that 95 percent of patients treated with combined IMBRUVICA® plus venetoclax were alive and progression-free at two years.[1] Deep remissions were seen across all subgroups, including patients with high-risk chronic lymphocytic leukemia (CLL).1 In addition, long-term data from the RESONATE-2 (PCYC-1115/1116) study will be presented, providing the longest follow-up Phase 3 data for any BTK inhibitor to date. Thes...
Source: Johnson and Johnson - May 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer
May 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated data from the Phase 1 CHRYSALIS study showing treatment with amivantamab in combination with lazertinib led to a median duration of response (DOR) of 9.6 months in chemotherapy-naïve patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations whose disease had progressed after treatment with osimertinib.[1] These data, which will be presented in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual ...
Source: Johnson and Johnson - May 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Joins World Health Organization in Efforts to Prevent Spread of Ebola in West Africa
Discussions are ongoing with the U.S. Food and Drug Administration regarding the approval of the vaccine regimen in the U.S. WHO Prequalification is often a prerequisite for national registrations of new vaccines and medicines in developing countries. Johnson & Johnson now looks forward to collaborating with the WHO’s African Vaccine Regulatory Forum (AVAREF) to progress national registrations of the Company’s Ebola vaccine regimen. The Company’s Ebola vaccine regimen is designed to be used proactively to induce immunity against Ebola virus disease in adults and children. Johnson & Johnson’s...
Source: Johnson and Johnson - May 13, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Pulmonary endarterectomy achieves excellent results for patients with segmental CTEPH
(American Association for Thoracic Surgery) A new study, presented today at the AATS 101st Annual Meeting, found that patients treated surgically for segmental Chronic Thromboembolic Pulmonary Hypertension (CTEPH) had excellent outcomes with the vast majority doing very well in the long term without any additional treatment other than surgery. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 2, 2021 Category: International Medicine & Public Health Source Type: news

Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision
NEW BRUNSWICK, N.J., April 23, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that vaccinations with the Company’s COVID-19 single-shot vaccine will resume for all adults aged 18 years and older in the U.S., under Emergency Use Authorization (EUA), following a decision from the United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA).The decision was based on a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP), which followed a rigorous evaluation of data relating to a very rare adverse event involving blood clots in combin...
Source: Johnson and Johnson - April 23, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

New Phase 3 Data Showed First-in-Class TREMFYA ® (guselkumab) Provided Durable Complete Skin Clearance Through Five Years in Moderate to Severe Plaque Psoriasis (PsO) and Robust Joint Symptom Improvement Through 52 Weeks in Active Psoriatic Arthritis (PsA)
SPRING HOUSE, PENNSYLVANIA, April 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new Phase 3 data which showed TREMFYA® (guselkumab) sustained durable, complete skin clearance rates in a majority of adults with moderate to severe plaque psoriasis (PsO) through five years (252 weeks), a and improved disease activity and axial symptoms in adults with active psoriatic arthritis (PsA) through one year (52 weeks).1,2,3 These data are being presented at the American Academy of Dermatology Virtual Meeting Experience 2021, where Janssen will present a total of 22 abstracts. TREMF...
Source: Johnson and Johnson - April 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news