U.S. FDA Approves CABENUVA (cabotegravir and rilpivirine) for Adolescents, Expanding the Indication of the First and Only Complete Long-Acting Injectable HIV Regimen
TITUSVILLE, N.J., March 29, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older, weigh at least 35 kg and are on a stable antiretroviral regimen, with no history of treatment failure, nor known or suspected resistance to either cabotegravir or rilpivirine.1,2 Co-developed as part of a collaboration with ViiV Healthcare, CABENUVA is the first ...
Source: Johnson and Johnson - March 30, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
New Data Show Majority of Adults with Moderate to Severe Plaque Psoriasis Treated with First-in-Class TREMFYA ® (guselkumab) Experienced Durable Skin Clearance Through Five Years Regardless of Metabolic Syndrome Status, Baseline Disease Severity, or Treatment History
SPRING HOUSE, PENNSYLVANIA, March 25, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced its first-in-class interleukin (IL)-23 inhibitor TREMFYA® (guselkumab) provided a consistent, high degree of durable skin clearance through five years in a majority of adult patients across broad subpopulations with moderate to severe plaque psoriasis (PsO) in the Phase 3 VOYAGE 1 and VOYAGE 2 clinical trials.1 A separate post hoc analysis of the VOYAGE studies showed TREMFYA provided high rates of efficacy and durability through five years and similar safety outcomes among patients with and without...
Source: Johnson and Johnson - March 25, 2022 Category: Pharmaceuticals Source Type: news
U.S. FDA Approves Streamlined Process for Initiating HIV Therapy with CABENUVA (cabotegravir and rilpivirine), the First and Only Complete Long-Acting Injectable HIV Treatment
TITUSVILLE, N.J., March 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved a label update for CABENUVA (cabotegravir and rilpivirine), giving healthcare professionals and people living with human immunodeficiency virus (HIV-1) in the U.S. the option to start this once-monthly or every-two-month injectable treatment without the need for the oral lead-in phase (daily cabotegravir and rilpivirine tablets, taken for one month prior to initiation of cabotegravir and rilpivirine injections).1 Clinical data demonstrated the regimen di...
Source: Johnson and Johnson - March 24, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Announces Series of Youth Initiatives Aimed at Helping to Empower a Generation to End Tuberculosis
NEW BRUNSWICK, N.J., March 24, 2022 – Today on World Tuberculosis (TB) Day, Johnson & Johnson (the Company) announced a series of initiatives in high TB burden countries aimed at helping to empower a generation of youth to end TB. The initiatives focus on supporting global efforts to help find the missing millions of people living with undiagnosed TB, and are part of Johnson & Johnson’s 10-year initiative to help drive progress toward the United Nations (UN) Sustainable Development Goal of ending this deadly, but preventable and treatable, disease by 2030.Johnson & Johnson, together with the Central TB Divi...
Source: Johnson and Johnson - March 24, 2022 Category: Pharmaceuticals Source Type: news
Janssen Initiates First-of-its-Kind Clinical Study to Bridge Critical Gaps in Care for People of Color with Moderate to Severe Plaque Psoriasis
HORSHAM, PENNSYLVANIA, March 22, 2022 – Psoriasis (PsO) can take a physical, psychological, and emotional toll on the more than 8 million Americans living with the disease; and for people of color, there are additional challenges due to limited medical research and education, as well as underrepresentation in clinical studies.1,2,3 This has led to a lack of data and barriers to optimal care for diverse patient populations.2 PsO may also present with less noticeable skin reddening on darker skin tones, which can make it harder for healthcare providers to identify and lead to misdiagnoses in people of color. To help addres...
Source: Johnson and Johnson - March 23, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Childhood maltreatment, mental well-being, and healthy lifestyle in patients with chronic thromboembolic pulmonary hypertension - Lepsy N, Dering MR, Fuge J, Meltendorf T, Hoeper MM, Heitland I, Kamp JC, Park DH, Richter MJ, Gall H, Ghofrani HA, Ellermeier D, Kulla HD, Olsson KM, Kahl KG.
INTRODUCTION: Chronic thromboembolic pulmonary hypertension (CTEPH) is a potentially life-threatening condition associated with high morbidity and mortality. However, advances in medical, surgical and interventional treatment have markedly improved the out... (Source: SafetyLit)
Source: SafetyLit - March 16, 2022 Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
South Africa Health Products Regulatory Authority Approves Dapivirine Ring Developed by the International Partnership for Microbicides
NEW BRUNSWICK, NJ, March 11, 2022 – Johnson & Johnson (the Company) welcomes the approval from the South African Health Products Regulatory Authority (SAHPRA) of the once-monthly dapivirine vaginal ring, developed by the not-for-profit International Partnership for Microbicides, Inc. (IPM), for use by women ages 18 and older to help reduce their risk of contracting HIV. The dapivirine ring, which is the first discreet, long-acting HIV prevention method designed exclusively for women, offers women a new option when deciding which method best meets their individual needs.The approval of the dapivirine ring in South Afr...
Source: Johnson and Johnson - March 11, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Janssen Seeks Approval of a New Indication for IMBRUVICA ® (ibrutinib) for Use in Patients with Untreated Mantle Cell Lymphoma
BEERSE, BELGIUM, 8 March 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for IMBRUVICA® (ibrutinib) in combination with bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation (ASCT).Ibrutinib is a once-daily Bruton's tyrosine kinase (BTK) inhibitor that is currently approved for patients with MCL who have received at least one prior lin...
Source: Johnson and Johnson - March 8, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Johnson & Johnson Announces Landmark Agreement to Enable its COVID-19 Vaccine to be Manufactured and Made Available by an African Company for People Living in Africa
NEW BRUNSWICK, NJ (March 8, 2022) – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the completion of a landmark agreement between Janssen Pharmaceuticals, Inc., and manufacturer Aspen SA Operations (Pty) Ltd, based in South Africa, to enable the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with the goal of increasing COVID-19 vaccination rates across the continent.Expanding global vaccination coverage is critically important to controlling the COVID-19 pandemic and reducing the risk of emergence of new SARS-CoV-2 variants. Currently, only...
Source: Johnson and Johnson - March 8, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
U.S. FDA Approves CARVYKTI ™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
HORSHAM, Pa., February 28, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has approved CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1 The approval is based on data from the pivotal CARTITUDE-1 study, which included patients who had received a median of six prior treatment regimens (range, 3-18), and had previously rec...
Source: Johnson and Johnson - March 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Bayer launches KSA ’s first digital platform for pulmonary hypertension management
Germany ’s Bayer has launched Saudi Arabia’s first “digital hub” to improve management of pulmonary hypertension (PH), it has announced. (Source: mobihealthnews)
Source: mobihealthnews - February 23, 2022 Category: Information Technology Source Type: news
Consumer Health: Understanding pulmonary hypertension
February is American Heart Month, which makes this a good time to learn about pulmonary hypertension. About 500-1000 new cases of this rare type of high blood pressure are diagnosed each year in the U.S., according to the American Lung Association. Pulmonary hypertension affects the arteries in the lungs and the right side of the heart. In contrast, regular hypertension, often called high blood pressure, is a common condition that affects the arteries throughout the… (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - February 21, 2022 Category: Databases & Libraries Source Type: news
Janssen Presents New Data Demonstrating the Combination of Niraparib and Abiraterone Acetate Plus Prednisone Significantly Improved Radiographic Progression-Free Survival as a First-Line Therapy in Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
SAN FRANCISCO, Feb. 14, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced initial results from the Phase 3 MAGNITUDE study evaluating the investigational use of niraparib, a selective poly-ADP ribose polymerase (PARP) inhibitor, in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination repair (HRR) gene alterations. At the final analysis for radiographic progression-free survival (rPFS), the treatment combination of niraparib and abiraterone acetate plus prednisone de...
Source: Johnson and Johnson - February 14, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
New ERLEADA ® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
SAN FRANCISCO, Feb. 14, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new real-world evidence data showing the initiation of ERLEADA® (apalutamide) results in high rates of rapid and deep prostate-specific antigen (PSA) response among patients with metastatic castration-sensitive prostate cancer (mCSPC). In a separate post-hoc analysis of the registrational Phase 3 SPARTAN and TITAN studies, rapid and deep PSA responses with ERLEADA® were associated with improvement in patient-reported outcomes (PROs) related to quality of life, physical wellbeing, pain, and fatigue intensity. The...
Source: Johnson and Johnson - February 14, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Identifying Severe Pulmonary Hypertension in Patients With COPD Identifying Severe Pulmonary Hypertension in Patients With COPD
Patients with COPD and severe pulmonary hypertension may benefit from individualized treatment.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 3, 2022 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news
