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 21, 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

ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Non-Metastatic Castration-Resistant Prostate Cancer
RARITAN, NJ, May 13, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA® (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.[i] Results will be presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program (Abstract #5516) beginning May 29th. ERLEADA® ...
Source: Johnson and Johnson - May 14, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Inhaled Nitric Oxide Explored for COVID-19 Oxygenation
Clinicians filed an emergency application to treat a COVID-19 patient with pulmonary hypertension with nitrous oxide from a tankless device at home, and their findings have spurred clinical trials. (Source: WebMD Health)
Source: WebMD Health - May 13, 2020 Category: Consumer Health News Source Type: news

Inhaled Nitric Oxide Explored for COVID-19 Oxygenation Inhaled Nitric Oxide Explored for COVID-19 Oxygenation
Clinicians filed an emergency application to treat a COVID-19 patient with pulmonary hypertension with nitrous oxide from a tankless device at home, and their findings have spurred clinical trials.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 13, 2020 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

LSU Health study suggests nicotine exposure alone leads to pulmonary hypertension
(Louisiana State University Health Sciences Center) A study conducted at LSU Health New Orleans has shown for the first time that chronic exposure to inhaled nicotine alone increases blood pressure in both the body's general circulation and in the lungs that can lead to pulmonary hypertension. The study also found that nicotine-induced pulmonary hypertension is accompanied by changes in the size, shape and function (remodeling) of the blood vessels in the lung and the right lower chamber of the heart. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 1, 2020 Category: International Medicine & Public Health Source Type: news

Janssen Announces Submission of Two Applications to U.S. FDA Seeking Approval of SIMPONI ARIA ® (golimumab) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis
HORSHAM, PA, April 24, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate. If approved for these indications, SIMPONI ARIA would be the first anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous infusion av...
Source: Johnson and Johnson - April 24, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For its COVID-19 Vaccine Candidate in Support of the Company ’s Goal to Supply More Than One Billion Vaccine Doses Globally
NEW BRUNSWICK, N.J., April 23, 2020 - Johnson & Johnson (the Company) (NYSE: JNJ) today announced a collaboration between the Janssen Pharmaceutical Companies of Johnson & Johnson and Emergent BioSolutions, Inc. to support the manufacturing of its lead investigational COVID-19 vaccine candidate. This is the first in a series of prospective global collaboration agreements designed to accelerate manufacturing of Johnson & Johnson’s COVID-19 vaccine candidate, and further the Company’s goal to supply more than one billion doses of the vaccine globally. Paul Stoffels, M.D., Vice Chairman of the Executiv...
Source: Johnson and Johnson - April 24, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

A retrospective study of suicide attempts in patients with pulmonary hypertension - Hu WS, Lin CL.
This study enrolled 7,727 pulmonary hypertension patients and 7,727 comparison subjects. The multivariate Cox proportional hazard model was used... (Source: SafetyLit)
Source: SafetyLit - April 23, 2020 Category: International Medicine & Public Health Tags: Ergonomics, Human Factors, Anthropometrics, Physiology Source Type: news

U.S. FDA Approves IMBRUVICA ® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
HORSHAM, Pa., April 21, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to therapy. The approval is based on positive results from the landmark Phase 3 E1912 study that was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health. Today’s mi...
Source: Johnson and Johnson - April 22, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Results from Expert Delphi Consensus Survey on Treatment of Pulmonary Arterial Hypertension (PAH) with Oral Prostacyclin Pathway Agents (PPAs) Published in CHEST Journal
SOUTH SAN FRANCISCO, CA, April 3, 2020 – Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, today announced that CHEST, the official publication of the American College of Chest Physicians, published results from an expert Delphi consensus survey that help provide additional insights for physicians to advance the care of patients with pulmonary arterial hypertension (PAH).The Prostacyclin International Expert Panel developed the consensus opinions based on common clinical scenarios in which they considered adding oral prostacyclin pathway agents (PPAs), including UPTRAVI®...
Source: Johnson and Johnson - April 3, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use
NEW BRUNSWICK, N.J., March 30, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The Company expects to initiate human clinical studies of its ...
Source: Johnson and Johnson - March 30, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Landmark Phase 3 VOYAGER PAD Study of XARELTO ® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI[1] major bleeding. VOYAGER PAD is the only study to show a significant benefi...
Source: Johnson and Johnson - March 28, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

FDA Grants VERO Biotech Expanded Access Emergency Use for the Treatment of Patients with COVID-19, with the GENOSYL(R) DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide
The recently FDA-approved GENOSYL® inhaled nitric oxide may have pulmonary and antiviral benefits in treating pulmonary hypertension and acute infectious diseases associated with the novel coronavirus[1] GENOSYL® DS facilitates outpatient use of... Biopharmaceuticals, Drug Delivery, FDA VERO Biotech, GENOSYL, Nitric Oxide (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 26, 2020 Category: Pharmaceuticals Source Type: news

Janssen Announces Health Canada Approval of CABENUVA ™, the First Long-Acting Regimen for the Treatment of HIV
Cork, Ireland, March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that Health Canada has approved CABENUVA™ (cabotegravir and rilpivirine extended release injectable suspensions), the first and only once-monthly, long-acting regimen for the treatment of HIV-1 infection in adults. CABENUVA™ is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]). CABENUVA™, a co-packaged kit with ...
Source: Johnson and Johnson - March 20, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Highlights Continued Commitment to Cardiovascular & Metabolic Healthcare Solutions with Late-Breaking Data at the First Fully Virtual American College of Cardiology Scientific Session
RARITAN, N.J., March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the virtual American College of Cardiology’s 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) on March 28-30, 2020. Notably, four late-breaking abstracts for XARELTO® (rivaroxaban) will be presented, including data from the Phase 3 VOYAGER PAD study in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization.Click to...
Source: Johnson and Johnson - March 20, 2020 Category: Pharmaceuticals Source Type: news

Johnson & Johnson Announces Collaboration with the Beth Israel Deaconess Medical Center to Accelerate COVID-19 Vaccine Development
NEW BRUNSWICK, N.J., March 13, 2020 – Johnson & Johnson today announced that its Janssen Pharmaceutical Companies have entered a collaboration with the Beth Israel Deaconess Medical Center (BIDMC) to support the development of a preventive vaccine candidate for COVID-19. The parties have commenced preclinical testing of multiple vaccine prospects, with the aim to identify by the end of the month a COVID-19 vaccine candidate for clinical trials.Janssen is optimistic that, in collaboration with multiple global strategic partners, it can initiate a Phase 1 clinical study of a potential vaccine candidate by the end o...
Source: Johnson and Johnson - March 13, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

Janssen Announces Results of Phase 3 Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen of Rilpivirine And Cabotegravir through 96 Weeks
CORK, IRELAND, March 9, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson presented new data from the global Phase 3 trial today for the novel, investigational, long-acting (LA), two-drug injectable regimen – a combination of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir. The study – First Long-Acting Injectable Regimen (FLAIR) trial – demonstrated positive 96-week results in long-term safety and efficacy of rilpivirine and cabotegravir. These data were presented at the 2020 Conference on Retroviruses and Opportunistic Infections (CROI)“In our quest to...
Source: Johnson and Johnson - March 11, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces 48-week Results of Phase 3b Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment of Rilpivirine and Cabotegravir Administered Every Two Months
CORK, IRELAND, March 9, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson presented new data from its global Phase 3b trial today for the novel, investigational, long-acting (LA), two-drug injectable regimen – a combination of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir. The study – Antiretroviral Therapy as Long-Acting Suppression every 2 Months (ATLAS-2M) trial – met its primary endpoint at Week 48, showing that the therapy, injected every eight weeks, had similar safety and efficacy in maintaining viral suppression in adults living with HIV-1, as treatm...
Source: Johnson and Johnson - March 11, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer
RARITAN, NJ, March 10, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) 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. JNJ-6372 is an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.[1...
Source: Johnson and Johnson - March 10, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

European Medicines Agency Grants PRIME and Advanced Therapy Medicinal Product Designations to Janssen ’s RPGR Gene Therapy for X-Linked Retinitis Pigmentosa
RARITAN, NJ, March 2, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Medicines Agency (EMA) has granted both PRIME (PRIority MEdicines) and Advanced Therapy Medicinal Product (ATMP) designations to the company’s adeno-associated virus (AAV)-RPGR gene therapy product for the treatment of inherited retinal disease X-linked retinitis pigmentosa (XLRP). PRIME is awarded to increase interactions, optimize development plans and accelerate innovative treatments where there is unmet medical need. Similarly, ATMP status is granted to medicines that are based on gen...
Source: Johnson and Johnson - March 2, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Aria CV Wants to Offer a Device Option for Pulmonary Arterial Hypertension
Aria CV is venturing into a space that few medtech companies have gone before. The St. Paul MN-based company is developing an implantable device to tackle Pulmonary Arterial Hypertension (PAH), a disease that is mostly treated with pharmaceuticals. Earlier this week, the company raised $31 million in a series B round to help fund an early feasibility study in the U.S. for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The series B round was led by Xeraya Capital. Also participating in the financing were Longview Ventures, Catalyst Health Ventures, BioStar Ventures, Cedar Point Capital, Frontcourt Group, and...
Source: MDDI - February 27, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Johnson & Johnson Launches Heartline ™, the First-of-its-Kind, Virtual Study Designed to Explore if a New iPhone App and Apple Watch Can Help Reduce the Risk of Stroke
New Brunswick, NJ, February 25, 2020 — Johnson & Johnson (NYSE: JNJ) today announced that the Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with Apple, opened enrollment for the Heartline™ Study. The study is designed to explore if the Heartline™ Study app on iPhone and heart health features on Apple Watch can improve health outcomes, including reducing the risk of stroke, with earlier detection of atrial fibrillation (AFib). AFib, a common form of irregular heart rhythm, is a leading cause of stroke in the U.S. To enroll in the Heartline™ Study, individuals must be...
Source: Johnson and Johnson - February 25, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Hormone adjustment may lead to new ways to prevent and treat lung damage in premature infants
(Elsevier) Prematurely born babies often need oxygen therapy to prevent brain damage or death. Unfortunately, excessive oxygen can damage immature lungs and cause severe life-long problems including bronchopulmonary dysplasia (BPD) and pulmonary hypertension (PH). A new study in The American Journal of Pathology, published by Elsevier, provides insights into the important role that the hormone adrenomedullin plays in the development, recovery, and prevention of BPD and PH. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 21, 2020 Category: International Medicine & Public Health Source Type: news

Johnson & Johnson to Expand Partnership with U.S. Department of Health & Human Services to Accelerate the Discovery of Potential COVID-19 Treatments
NEW BRUNSWICK, N.J., February 18, 2020 – Johnson & Johnson today announced that its Janssen Pharmaceutical Companies will expand its existing partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services, to seek treatment solutions for COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2 (also known as 2019-nCoV). This latest collaboration will enhance Janssen’s ongoing work with global partners to screen a library of existing antiviral...
Source: Johnson and Johnson - February 18, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Announces Collaboration with U.S. Department of Health & Human Services to Accelerate Development of a Potential Novel Coronavirus Vaccine
NEW BRUNSWICK, N.J., February 11, 2020 – Johnson & Johnson today announced that its Janssen Pharmaceutical Companies will further expedite its investigational coronavirus vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services. The collaborative partnership with BARDA builds on Johnson & Johnson’s multipronged response to the new coronavirus disease (COVID-19) outbreak. In addition to Janssen’s ef...
Source: Johnson and Johnson - February 11, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Announces Submission to U.S. FDA for New DARZALEX ® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma
RARITAN, NJ, February 10, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for relapsed/refractory multiple myeloma. The sBLA is supported by results from the Phase 3 CANDOR study, which compared treatment with DKd to carfilzomib and dexamethasone (Kd) in patients with multiple myeloma who relapsed after one to three prior lines of therapy. “W...
Source: Johnson and Johnson - February 10, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen to Highlight Depth of Solid Tumor Portfolio at ASCO GU
RARITAN, N.J., February 3, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today multiple data presentations from a robust solid tumor portfolio that will be featured at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, taking place February 13-15 in San Francisco. Company-sponsored data presentations will include clinical results for ERLEADA® (apalutamide) and niraparib in prostate cancer; and BALVERSA™ (erdafitinib) in bladder cancer. “We are committed to improving outcomes in patients with prostate and bladder cancer where high unmet...
Source: Johnson and Johnson - February 3, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news