Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations
RARITAN, N.J., February 28, 2023 – 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) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet (DAT), plus prednisone, for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). If approved, this will be the first DAT formulation available in the U.S. to patients with mCRPC with BRCA mutations, which are a type of homologous recombination repair (HRR) gene alt...
Source: Johnson and Johnson - March 1, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Janssen Receives Positive CHMP Opinion for AKEEGA ® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer
BEERSE, Belgium, 24 February 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for AKEEGA® (niraparib and AA), in the form of a DAT, given with P or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.[1]Niraparib is a highly selective poly adenosine diphosphate-ribose polymerase (PARP) inhibi...
Source: Johnson and Johnson - February 27, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
SAN FRANCISCO, February 16, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced updated results from the Phase 3 MAGNITUDE study evaluating the investigational use of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination repair (HRR) gene alterations, including BRCA mutations. Results will be featured today in a Rapid Abstract Session (Abstract #170) at the American Society of Clinica...
Source: Johnson and Johnson - February 16, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Johnson & Johnson Names Paula A. Johnson, President of Wellesley College, to its Board of Directors
New Brunswick, N.J., February 14, 2023 – Johnson & Johnson (NYSE: JNJ) announced today that Paula A. Johnson, MD, MPH, President of Wellesley College, has been appointed to its Board of Directors.“I am excited to welcome Dr. Paula Johnson to Johnson & Johnson’s Board of Directors,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “Paula is an impressive leader, physician-scientist, and educator, with expertise in improving health outcomes for patients around the globe. Her extensive knowledge of medical research, public health, and health policy, and her proven leadership a...
Source: Johnson and Johnson - February 14, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Johnson & Johnson to Participate in the Barclays Global HealthCare Conference
New Brunswick, NJ (February 13th, 2023) -- Johnson & Johnson (NYSE: JNJ) will participate in the Barclays Global HealthCare Conference on Tuesday, March 14th, at the Loews Miami Beach Hotel, Miami Beach, Florida. Aldo Denti, Company Group Chairman DePuy Synthes and Peter Menziuso, Company Group Chairman, Vision will represent the Company in a session scheduled at 10:15 a.m. (Eastern Time).This live audio webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.The audio webcast replay will be available approximately 48-hrs after the webca...
Source: Johnson and Johnson - February 14, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Janssen Data at ASCO GU Support Ambition to Transform Treatment of Prostate and Bladder Cancer Through Precision Medicine and Early Intervention
RARITAN, N.J., February 13, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced plans to present more than 20 abstracts featuring seven oncology therapies from its robust portfolio and pipeline at the annual American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place in San Francisco on February 16-18. Building on more than a decade of leadership in the development of medicines for people diagnosed with GU cancers, Janssen will present data demonstrating its ambition to advance patient-centered treatment through precision medicine, real-world evidence a...
Source: Johnson and Johnson - February 13, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Johnson & Johnson Appoints Dr. John Reed as Executive Vice President, Pharmaceuticals, R & D
New Brunswick, NJ, February 13, 2023 - Johnson & Johnson (NYSE: JNJ) (the Company) today announced the appointment of John Reed, M.D., Ph.D., to the Company’s Executive Committee as Executive Vice President of Pharmaceuticals, R&D. Dr. Reed previously served as Executive Vice President, Global Head of Research and Development for Sanofi and brings more than 35 years of biomedical research leadership to the Company.Dr. Reed will join Johnson & Johnson on April 3, 2023, assuming responsibility for the Company’s industry-leading portfolio from William Hait, M.D., Ph.D., who has served as interim head of Johnso...
Source: Johnson and Johnson - February 13, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Johnson & Johnson Statement on the Earthquakes in Turkey and Syria
NEW BRUNSWICK, N.J., February 9, 2023 – Johnson & Johnson extends our sympathy and support to the thousands of people affected by the devastating earthquakes in Turkey and Syria.In the immediate aftermath of this disaster, we have been assisting the region by:Pledging $1 million for disaster relief efforts to support the following NGOs: International Medical Corps (IMC) and International Rescue Committee (IRC).Donating funds to Direct Relief for immediate support of the rescue efforts on the ground in Turkey.Donating thermal blankets and working to provide other items in urgent need, including hygiene products, surgi...
Source: Johnson and Johnson - February 9, 2023 Category: Pharmaceuticals Source Type: news

Janssen Reports Positive Topline Phase 2 Results for Nipocalimab in Pregnant Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
SPRING HOUSE, PENNSYLVANIA, February 6, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive topline results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN). HDFN is a serious and rare condition which can cause life-threatening anemia in the fetus. It occurs when the blood types of a pregnant individual and their fetus are incompatible.1 The trial met the primary endpoint, with the majority of pregnant patients who received nipocalimab achieving a live b...
Source: Johnson and Johnson - February 8, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Johnson & Johnson Statement on War in Ukraine Anniversary
NEW BRUNSWICK, N.J., February 8, 2023 – As a global healthcare company, Johnson & Johnson believes access to healthcare is fundamental. One year following the start of the war in Ukraine, we remain committed to our employees, their families, and the people of Ukraine. We have:Provided employees with a range of support including, security and immigration advice; financial assistance; resettlement and redeployment support; and assistance with mental health and well-being.Donated $10 million to support humanitarian assistance work and continuing to honor non-profit partner product requests in support of the crisis, as w...
Source: Johnson and Johnson - February 8, 2023 Category: Pharmaceuticals Source Type: news

Johnson & Johnson to Participate in the Cowen 43rd Annual HealthCare Conference
New Brunswick, NJ (February 2nd, 2023) -- Johnson & Johnson (NYSE: JNJ) will participate in the Cowen 43rd Annual HealthCare Conference on Tuesday, March 7th, at the Boston Marriott Copley Place, Boston, MA. Joseph J. Wolk, Executive Vice President and Chief Financial Officer will represent the Company in a session scheduled at 11:10 a.m. (Eastern Time).This live audio webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.The audio webcast replay will be available approximately 48-hrs after the webcast. (Source: Johnson and Johnson)
Source: Johnson and Johnson - February 2, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI ® (cilta-cel) as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple Myeloma
RARITAN, New Jersey, January 27, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) for the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma met its primary endpoint of significant improvement in progression-free survival (PFS) at the first pre-specified interim analysis. As a result of meeting the primary endpoint, the Independent Data Monitoring Commi...
Source: Johnson and Johnson - January 27, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Johnson & Johnson Reports Q4 and Full-Year 2022 Results
NEW BRUNSWICK, N.J. – January 24, 2023 – Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full year 2022. “Our full year 2022 results reflect the continued strength and stability of our three business segments, despite macroeconomic challenges,” said Joaquin Duato, Chairman of the Board and Chief Executive Officer. “I am inspired by our employees who make a difference in the health and lives of people around the world every day. As we look ahead to 2023, Johnson & Johnson is well-positioned to drive near-term growth, while also investing strategically to deliver long-term value...
Source: Johnson and Johnson - January 24, 2023 Category: Pharmaceuticals Source Type: news

Johnson & Johnson to Participate in the SVB Securities Global Biopharma Conference
New Brunswick, NJ (January 18th, 2023) -- Johnson & Johnson (NYSE: JNJ) will participate in the SVB Securities Global Biopharma Conference on Wednesday, February 15th. Biljana Naumovic, Worldwide Vice President, Oncology and Peter Lebowitz, Global Therapeutic Head, Oncology will represent the Company in a virtual session scheduled at 1:00 p.m. (Eastern Time).This live audio webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.The audio webcast replay will be available approximately 48-hrs after the webcast. (Source: Johnson and Johnson)
Source: Johnson and Johnson - January 18, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Janssen and Global Partners to Discontinue Phase 3 Mosaico HIV Vaccine Clinical Trial
LEIDEN, THE NETHERLANDS, (January 18, 2023) – The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, today announced the results of an independent, scheduled data review of the Phase 3 Mosaico study (also known as HPX3002/HVTN706) of Janssen’s investigational HIV vaccine regimen. The study’s independent Data and Safety Monitoring Board (DSMB) determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified.In light of the DSMB’s determination, the Mo...
Source: Johnson and Johnson - January 18, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news