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 multiple m...
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 high ov...
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 to discont...
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 has...
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 protein that ...
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 Phase 3 ENS...
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 retini...
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 for data in ...
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 subcutaneous for...
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 revascularization, a c...
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 to our C...
Source: Johnson and Johnson - October 8, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news
