Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV
TITUSVILLE, N.J., January 21, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holde...
Source: Johnson and Johnson - January 22, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to th...
Source: Johnson and Johnson - January 16, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Inhaled Treprostinil Beneficial in Pulmonary Hypertension
Exercise capacity improved, clinical worsening reduced for patients with pulmonary HTN due to interstitial lung disease (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - January 14, 2021 Category: Respiratory Medicine Tags: Cardiology, Pharmacy, Pulmonology, Journal, Source Type: news

Inhaled Treprostinil Beneficial in Pulmonary Hypertension
THURSDAY, Jan. 14, 2021 -- Inhaled treprostinil improves exercise capacity in patients with pulmonary hypertension due to interstitial lung disease, according to a study published online Jan. 13 in the New England Journal of Medicine. Aaron Waxman,... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 14, 2021 Category: Pharmaceuticals Source Type: news

Janssen to Highlight Commitment to Lung Cancer Science and Innovation with Eight Data Presentations at the International Association for the Study of Lung Cancer ’s 2020 World Conference on Lung Cancer
January 12, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that eight company-sponsored presentations, including two oral presentations, will be featured at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore taking place virtually January 28-31, 2021. The presentations include updated data from the Phase 1 CHRYSALIS study (NCT02609776) evaluating amivantamab in patients with NSCLC and EGFR exon 20 insertion mutations and two studies that characterize the high unmet need and lack of stand...
Source: Johnson and Johnson - January 13, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma
December 21, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the initiation of a rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed and/or refractory multiple myeloma.“We are committed to innovation in cell therapy and advancing the science of multiple myeloma to improve patients’ lives,” said Pete...
Source: Johnson and Johnson - December 21, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Data Demonstrate Long-Term Benefit of IMBRUVICA ® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukemia
This study highlighted the need for cytogenetic/molecular testing before CIT treatment, consistent with clinical treatment guidelines.[8],[9]Real-World Prognostic Biomarker Testing, Treatment Patterns, And Dosing Among Patients With CLL/SLL From the informCLL™ Prospective Observational Registry (Abstract #547)An oral presentation on Monday, December 7, will feature results from the informCLL™ real-world prospective observational registry assessing treatment patterns in the era of novel agents.4 Key Study Findings:· The most common index treatment was IMBRUVICA®; the majority of patients treated with ...
Source: Johnson and Johnson - December 6, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents First Data from the Phase 1 Study of the GPRC5DxCD3 Bispecific Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma
December 5, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today initial data for the Phase 1 first-in-human dose escalation study of talquetamab (JNJ-64407564) for the treatment of relapsed or refractory multiple myeloma (NCT03399799). Talquetamab is a first-in-class, and the only investigational bispecific antibody that targets both GPRC5D, a novel multiple myeloma target, and CD3 on T-cells. Initial results for both the subcutaneous (SC) and intravenous (IV) formulations show encouraging clinical activity against the GPRC5D target, which is highly expressed on multip...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Updated Results from the Phase 1 Study of the BCMAxCD3 Bispecific Teclistamab Show Preliminary Efficacy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma
This study evaluated the ability of teclistamab to induce cytotoxicity and T-cell activation.About TeclistamabTeclistamab is an investigational bispecific antibody targeting both BCMA and CD3. BCMA, B-cell maturation antigen, is expressed at high levels on multiple myeloma cells.[3],[4],[5],[6],[7] Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce cytotoxicity of the targeted cells.5,6 Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients.6 Teclistamab is currently being evaluated in a...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Early, Deep, Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) Observed in Phase 1b/2 CARTITUDE-1 Study Show Potential of BCMA CAR-T in Treatment of Heavily Pretreated Patients with Multiple Myeloma
December 5, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today longer-term results from the combined Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of ciltacabtagene autoleucel (cilta-cel), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma. These data, presented as an oral presentation at the American Society of Hematology (ASH) 2020 Annual Meeting (Abstract #177), continued to demonstrate a very hig...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA ® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukemia
December 5, 2020 (RARITAN, N.J.) – New data from the Phase 2 CAPTIVATE study were presented today during an oral session at the 2020 American Society of Hematology (ASH) Annual Meeting (Abstract #123). The study evaluated the efficacy and safety of IMBRUVICA® (ibrutinib) plus venetoclax in the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and showed that, after achieving undetectable minimal residual disease (uMRD) in both the blood and bone marrow with the IMBRUVICA® combination regimen, the one-year disease-free survival (DFS) of patients randomized ...
Source: Johnson and Johnson - December 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
RARITAN, N.J., December 3, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The application marks the first-ever regulatory submission for the treatment of patients with NSCLC with EGFR exon 20 insertion mutations.[1] The Company...
Source: Johnson and Johnson - December 3, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Acquires Rights to Novel Gene Therapy, Pioneering Treatment Solutions for Late-Stage Age-Related Macular Degeneration
RARITAN, NJ, December 2, 2020 – Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced the acquisition of rights to Hemera Biosciences, LLC’s investigational gene therapy HMR59, administered as a one-time, outpatient, intravitreal injection to help preserve vision in patients with geographic atrophy, a late-stage and severe form of age-related macular degeneration (AMD). Financial terms of the transaction with Hemera Biosciences, a privately-owned biotechnology company, are not being disclosed. Patients with AMD often have low levels of CD59, a prote...
Source: Johnson and Johnson - December 2, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson and U.S. Department of Health & Human Services Expand Agreement to Support Next Phase of COVID-19 Vaccine Candidate Research and Development
NEW BRUNSWICK, N.J., November 14, 2020 – Johnson & Johnson (the Company) announced the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services for the ongoing development of Janssen’s investigational COVID-19 vaccine candidate.Under the amendment, Janssen will commit approximately $604 million and BARDA will commit approximately $454 million to support the ongoing Pha...
Source: Johnson and Johnson - November 14, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Late-Breaking 12-Month Data of Investigational RPGR Gene Therapy Shows Statistically Significant and Continued Vision Improvement in Patients with X-Linked Retinitis Pigmentosa
RARITAN, N.J., November 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new 12-month data from the ongoing Phase 1/2 trial (NCT03252847) of its investigational gene therapy for inherited retinal disease X-linked retinitis pigmentosa (XLRP). The data showed that low and intermediate doses were well-tolerated and continued to demonstrate statistically significant sustained or increased vision improvement across multiple metrics (mean sensitivity, volumetric and pointwise) and modalities (full-field static perimetry and microperimetry). Data on the novel adeno-associated virus re...
Source: Johnson and Johnson - November 13, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

New XARELTO ® (rivaroxaban) Peripheral Artery Disease (PAD) Data from EXPLORER Clinical Research Program to be Unveiled at American Heart Association (AHA) Scientific Sessions 2020
RARITAN, N.J., November 9, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that 10 data presentations will be shared at the virtual American Heart Association (AHA) Scientific Sessions 2020 from November 13-17. Most notably, four new sub-analyses of XARELTO® (rivaroxaban) from the landmark VOYAGER PAD trial, part of the EXPLORER global cardiovascular research program, will be presented, including two live, featured science oral presentations. “We're pleased VOYAGER PAD was selected to be front and center once again at a major medical congress, as there's an urgent need f...
Source: Johnson and Johnson - November 9, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Headlines American Society of Hematology Annual Meeting With More Than 35 Presentations Highlighting Deep, Diverse Oncology Pipeline and Portfolio
RARITAN, N.J., November 5, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today more than 35 company-sponsored studies, including 10 oral presentations, will be featured at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.In multiple myeloma, highlights include Phase 1b/2 results for the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy ciltacabtagene autoleucel (cilta-cel); new and updated data for the anti-CD38 monoclonal antibody DARZALEX® (daratumumab) and the subcutane...
Source: Johnson and Johnson - November 5, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Nanox to integrate Ambra Health's medical image management software; ACTO acquires CoHealth's content delivery app; and more digital health deals
Also: Vocalis Health and Mayo Clinic seek new  pulmonary hypertension biomarkers; Sensyne Health and Microsoft's strategic partnership focuses on clinical AI co-development. (Source: mobihealthnews)
Source: mobihealthnews - October 29, 2020 Category: Information Technology Source Type: news

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revasculariz...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.
Discussions with other regulators around the world to resume the clinical trial program are progressing. After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified. There are many possible factors that could have caused the event. Based on the information gathered to date and the input of independent experts, the Company has found no evidence that the vaccine candidate caused the event.At Johnson & Johnson, there is no greater priority than the health and safety of the people we serve every day around the world. Our primary goal is to ensure the safet...
Source: Johnson and Johnson - October 23, 2020 Category: Pharmaceuticals Source Type: news

Heart Defects Don't Increase Risk of Severe COVID
Among the 43 adults and 10 children with a congenital heart defect who were infected with COVID-19, 58% had complex congenital anatomy, 15% had a genetic syndrome, 11% had pulmonary hypertension and 17% were obese. (Source: WebMD Health)
Source: WebMD Health - October 16, 2020 Category: Consumer Health News Source Type: news

Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen ’s COVID-19 Vaccine Candidate
New Brunswick, N.J., October 8, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to EU Member States following approval or authorization from regulators. The EU Member States also have the option to secure up to 200 million additional doses.“The COVID-19 pandemic continues to threaten communities worldwide and we have a responsibility to ensure access ...
Source: Johnson and Johnson - October 8, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

High blood pressure: The dizzy sensation that may indicate risk of pulmonary hypertension
HIGH blood pressure has many factors people need to be aware of. If you feel dizzy or breathless when exerting yourself, it could indicate a worrying condition known as pulmonary hypertension. (Source: Daily Express - Health)
Source: Daily Express - Health - October 6, 2020 Category: Consumer Health News Source Type: news

Johnson & Johnson Completes Acquisition of Momenta Pharmaceuticals, Inc.
NEW BRUNSWICK, N.J., October 1, 2020 -- Johnson & Johnson (NYSE: JNJ) today announced it has successfully completed its acquisition of Momenta Pharmaceuticals, Inc. (“Momenta”), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 billion.“We’re delighted to welcome Momenta’s talented team to the Janssen Pharmaceutical Companies of Johnson & Johnson and to begin our work together to further advance patient care in autoantibody-driven diseases,” said Jennifer Taubert, Executive Vice President, Worldwi...
Source: Johnson and Johnson - October 1, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

SIMPONI ARIA ® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older
HORSHAM, PA, September 30, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab) for patients 2 years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population. “This latest FDA approval of SIMPONI ARIA for pediatric use in active pJIA and active PsA not only brings a new option to young patients living with these diseases but also adds to the growing body of evidence for this treatment,” said Mathai Mammen, M.D., Ph.D., Glo...
Source: Johnson and Johnson - September 30, 2020 Category: Pharmaceuticals Source Type: news

Janssen Submits New Drug Application (NDA) to U.S. FDA for UPTRAVI ® (selexipag) Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH)
SOUTH SAN FRANCISCO, CA – September 30, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UPTRAVI® (selexipag) as an injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults with WHO functional class (FC) II–III, who are currently prescribed oral UPTRAVI but are temporarily unable to take oral therapy. In patients with PAH, interruptions in treatment should be avoided due to the progressive nature of the disease...
Source: Johnson and Johnson - September 30, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen ’s COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. These results have been submitted to medRxiv and are due to be published online i...
Source: Johnson and Johnson - September 23, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

New virtual screening tool eases, accelerates routine diagnosis of pulmonary hypertension
(Temple University Health System) The COVID-19 pandemic has increasing numbers of doctors caring for patients virtually. While critical to protecting patient health during a pandemic, however, virtual care presents unique challenges, especially when it comes to diagnosis. Now, cardiologists at the Lewis Katz School of Medicine at Temple University, have come up with a virtual screening tool that greatly simplifies the process of diagnosing a complex form of heart failure known as pulmonary hypertension. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 17, 2020 Category: International Medicine & Public Health Source Type: news

Biopharma Leaders Unite To Stand With Science
NEW YORK, September 8, 2020 — The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech (NASDAQ: BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), known as MSD outside the United States and Canada, Moderna, Inc. (Nasdaq: MRNA), Novavax, Inc. (Nasdaq: NVAX), Pfizer Inc. (NYSE: PFE), and Sanofi (NASDAQ: SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. All nine CEOs signed the following pledge: We, the un...
Source: Johnson and Johnson - September 8, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Coronavirus Risk Higher For Obese People, Vaccine May Be Less Effective, Study Says
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Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - August 27, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Boston News Covid-19 Boston, MA Health Healthcare Status Syndicated CBSN Boston Coronavirus Source Type: news

Pulmonary hypertension overview
(Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - August 20, 2020 Category: Consumer Health News Source Type: news

Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen ’s Leadership in Novel Treatments for Autoimmune Diseases
NEW BRUNSWICK, N.J., August 19, 2020 – Johnson & Johnson (NYSE:JNJ) today announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. (Momenta), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 billion. This acquisition provides an opportunity for the Janssen Pharmaceutical Companies of Johnson & Johnson to broaden its leadership in immune-mediated diseases and drive further growth through expansion into autoantibody-driven disease. The transaction will include full global rights to nipocalim...
Source: Johnson and Johnson - August 19, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

PVR Reassessed as Predictor of Heart Failure PVR Reassessed as Predictor of Heart Failure
A study of patients with pulmonary hypertension suggests a reconsideration of the accepted benchmark for pulmonary vascular hypertension as a predictor of heart failure may be warranted.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - August 14, 2020 Category: Cardiology Tags: Cardiology News Source Type: news

Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine
New Brunswick, N.J., August 05, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the United States following approval or Emergency Use Authorization by the U.S. Food and Drug Administration (FDA). The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of th...
Source: Johnson and Johnson - August 5, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Announces U.S. FDA Approval of SPRAVATO ® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior
TITUSVILLE, N.J. – (August 3, 2020) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation orbehavior.1 SPRAVATO® is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours,1 providing a new option for significant symptom relief until a longer-te...
Source: Johnson and Johnson - August 3, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-clinical Studies
NEW BRUNSWICK, N.J., July 30, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical studies. The data, published in Nature, show the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited a robust immune response as demonstrated by “neutralizing antibodies,” successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates (NHPs) in the pre-clinical s...
Source: Johnson and Johnson - July 30, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Casting a wider net to catch more cases of pulmonary hypertension
(Brigham and Women's Hospital) Investigators took an evidence-based approach to determine the lower end of the risk spectrum for PH based on pulmonary vascular resistance (PVR), which is resistance against blood flow from the pulmonary artery to the lungs. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 28, 2020 Category: International Medicine & Public Health Source Type: news

Interim Six-Month Data of RPGR Gene Therapy Shows Significant Vision Improvement in Patients Living with X-Linked Retinitis Pigmentosa
Click to Access Audio Press ReleaseRARITAN, NJ, July 17, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today six-month data from the ongoing Phase 1/2 trial (NCT03252847) of its investigational gene therapy for the treatment of inherited retinal disease X-linked retinitis pigmentosa (XLRP). The interim data showed that low and intermediate doses of the investigational adeno-associated virus retinitis pigmentosa GTPase regulator (AAV-RPGR) were generally well-tolerated and indicated significant improvement in vision. Initial data on the novel AAV-RPGR asset, jointly developed with Meir...
Source: Johnson and Johnson - July 17, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

TREMFYA ® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis
HORSHAM, PA, July 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.[1],[2] TREMFYA is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA. The safety and efficacy of TREMFYA in PsA have b...
Source: Johnson and Johnson - July 14, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Treprostinil Improves Walk Distance in Pulmonary Hypertension Treprostinil Improves Walk Distance in Pulmonary Hypertension
Exercise capacity increased after patients with pulmonary hypertension associated with interstitial lung disease were treated with the vasodilator for 16 weeks, new research shows.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 9, 2020 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

OSIC offers $55K in AI pulmonary fibrosis competition
The Open Source Imaging Consortium (OSIC), a global nonprofit consortium of...Read more on AuntMinnie.comRelated Reading: AI algorithm can help in incidental detection of PE Chest CT clarifies negative COVID-19 lab results Lung experts refine diagnostic criteria for IPF on CT Lung abnormalities at CT linked to in-hospital death Automated CT tool reveals pulmonary hypertension (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - July 8, 2020 Category: Radiology Source Type: news

Johnson & Johnson Announces European Commission Approval for Janssen ’s Preventive Ebola Vaccine
Discussions with the U.S. Food and Drug Administration (FDA) have taken place to define the required data set for filing US licensure. About Janssen’s Ebola Vaccine Regimen The Janssen preventive Ebola vaccine regimen, Ad26.ZEBOV and MVA-BN-Filo, utilizes a non-replicating viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors carry the genetic code of several Ebola virus proteins in order to trigger an immune response.Janssen’s vac...
Source: Johnson and Johnson - July 1, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus
SPRING HOUSE, PENNSYLVANIA, June 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today its decision to discontinue the Phase 3 LOTUS study of STELARA® (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE.The decision is based on data from a pre-planned interim efficacy analysis. Interim safety findings were consistent with the known safety profile of STELARA, and no new safety signals were identified. Investigators, study participants and health authorities have been informed of the decision. The company intends to thoroughly analyze the totality of...
Source: Johnson and Johnson - June 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

What Is the Main Cause of Pulmonary Hypertension
? (Source: eMedicineHealth.com)
Source: eMedicineHealth.com - June 18, 2020 Category: General Medicine Source Type: news

Subcutaneous Daratumumab Combination Resulted in Deep and Rapid Hematologic Responses and Improved Clinical Outcomes in the Treatment of Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
RARITAN, NJ, June 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the first randomized Phase 3 study investigating subcutaneous daratumumab[i] in the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare and potentially fatal disease.[1],[2] The data demonstrated subcutaneous daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (D-CyBorD) resulted in a higher hematologic complete response rate (CR), (53 percent vs. 18 percent [P
Source: Johnson and Johnson - June 15, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

New technical approach can enhance diagnosis of pulmonary hypertension
(Elsevier) The management and prognosis of pulmonary hypertension heavily relies on whether the pathology is localized in pulmonary arteries or veins. In particular, at early stages, it is challenging to distinguish pulmonary arterial hypertension (PAH) from the rare subtype of pulmonary veno-occlusive disease (PVOD) because clinical presentations of PAH and PVOD can be similar. A new study in The American Journal of Pathology, published by Elsevier, reports gene expression analysis of lung explant tissue can accurately differentiate PAH from PVOD. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - June 15, 2020 Category: Biology Source Type: news

Johnson & Johnson Announces Acceleration of its COVID-19 Vaccine Candidate; Phase 1/2a Clinical Trial to Begin in Second Half of July
NEW BRUNSWICK, N.J., June 10, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July. Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, “Based on the strength of the preclinical data we have seen so far and inter...
Source: Johnson and Johnson - June 10, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Johnson & Johnson Receives Positive CHMP Opinion for Janssen ’s Investigational Preventive Ebola Vaccine Regimen
Discussions with the FDA are ongoing to define the required data set for filing Janssen’s Ebola vaccine regimen under the FDA’s Animal Rule licensure pathway. About Janssen’s Ebola Vaccine Regimen The Janssen investigational preventive Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) utilizes a viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors are modified to safely carry the genetic code of an Ebola virus protein in order...
Source: Johnson and Johnson - May 29, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

U.S. FDA Approves New Pediatric Formulation of SIRTURO ® (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis
NEW BRUNSWICK, NJ, May 27, 2020 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new pediatric formulation of SIRTURO® (bedaquiline). SIRTURO® is now indicated for use as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multidrug-resistant tuberculosis (MDR‑TB). In the U.S., the medicine should be reserved for use when an effective treatment regimen cannot otherwise be provided. This indication received acceler...
Source: Johnson and Johnson - May 27, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen ’s BCMA CAR-T Therapy JNJ-4528 Showed Early, Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
RARITAN, NJ, May 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of JNJ-4528, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in the treatment of patients with relapsed or refractory multiple myeloma. Longer-term follow-up results from the Phase 1b portion of the study (n=29), to be shared in an oral presentation at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program (Abstract #8505), show t...
Source: Johnson and Johnson - May 14, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news