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 Commitment to E...
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 combination wi...
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. TREMFYA is t...
Source: Johnson and Johnson - April 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Cardiac Failure, Pulmonary Hypertension Secondary to Renal AVM Cardiac Failure, Pulmonary Hypertension Secondary to Renal AVM
Systemic AVM is a rare, but potentially reversible cause of high-output heart failure. This case emphasizes the importance of a detailed workup in a patient with heart failure symptoms.Journal of Medical Case Reports (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - April 22, 2021 Category: Intensive Care Tags: Family Medicine/Primary Care Journal Article Source Type: news
Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine
NEW BRUNSWICK, N.J., April 21, 2021 – Johnson & Johnson (the Company) today announced publication in the New England Journal of Medicine of primary data from the Phase 3 ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The publication of the primary analysis follows the topline efficacy and safety data announced in January, showing the trial met all primary and key secondary endpoints, and found that the Johnson & Johnson single-dose COVID-19 vaccine prevented hospitalization and death across all study participants ...
Source: Johnson and Johnson - April 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) ReviewEMA Confirms Overall Benefit-Risk Profile Remains Positive
NEW BRUNSWICK, N.J., April 20, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the Company’s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company’s COVID-19 vaccine. As a result, Johnson &...
Source: Johnson and Johnson - April 20, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
Janssen Provides Update on Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA® (abiraterone acetate) Plus Prednisone Combination
RARITAN, N.J., April 19, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that regulatory submissions based on the Phase 3 ACIS study, which evaluated the combination of ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) plus prednisone in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), will not be pursued. As presented at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium in February 2021, the ACIS study met its primary endpoint of radiographic progression-free survival (rPFS); however, combination...
Source: Johnson and Johnson - April 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Real-World Observational Analysis of UPTRAVI ® (selexipag) Underscores the Importance of Risk Assessment for Treating Pulmonary Arterial Hypertension (PAH) Patients
SOUTH SAN FRANCISCO, CA – April 6, 2021 – Findings from an analysis of the first 500 patients enrolled in the SPHERE registry (SelexiPag: tHe usErs dRug rEgistry) found more than three-quarters (76%) of pulmonary arterial hypertension (PAH) patients treated with UPTRAVI® (selexipag) either maintained (56%) or reduced (20%) their one-year mortality risk score. The SPHERE results were published in the April issue of the Journal of Heart and Lung Transplantation (JHLT). SPHERE is an ongoing real-world, observational, user registry using two different risk assessment methods that describes the clinical characteristics, ou...
Source: Johnson and Johnson - April 6, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
United Therapeutics Announces FDA Approval and Launch of Tyvaso(R) for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
First and only approved therapy in the United States for patients with PH-ILD, a serious, life-threatening disease with potentially more than 30,000 patients in need
FDA approval based on data from the INCREASE clinical trial
PH-ILD is the second FDA... Biopharmaceuticals, FDA, Product Launch United Therapeutics, Tyvaso, treprostinil, pulmonary hypertension (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 1, 2021 Category: Pharmaceuticals Source Type: news
United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.
The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 1, 2021 Category: Health Management Authors: Rebecca Cooper Source Type: news
United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.
The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 1, 2021 Category: Biotechnology Authors: Rebecca Cooper Source Type: news
United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.
The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 1, 2021 Category: Health Management Authors: Rebecca Cooper Source Type: news
United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.
The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 1, 2021 Category: Biotechnology Authors: Rebecca Cooper Source Type: news
Johnson & Johnson Announces Advance Purchase Agreement with the African Vaccine Acquisition Trust for the Company ’s COVID-19 Vaccine Candidate
NEW BRUNSWICK, NJ (March 29, 2021) - Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to make available up to 220 million doses of its single-shot COVID-19 vaccine candidate to African Union’s 55 member states with delivery beginning in the third quarter of 2021. AVAT also has the potential to order an additional 180 million doses, for a combined total of up to 400 million doses through 2022. The availability of the vaccine candidate is subject to its successful approval...
Source: Johnson and Johnson - March 29, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news
