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Total 43 results found since Jan 2013.

News at a glance: China ’s ethics oversight, ARPA-H’s new science, and $210 million for protein research
PUBLIC HEALTH FDA advisers back maternal RSV shot A vaccine aims to protect infants from respiratory syncytial virus, a leading cause of infant hospitalization. JAMIE KELTER DAVIS/ THE NEW YORK TIMES /REDUX A panel advising the U.S. Food and Drug Administration (FDA) last week recommended that it approve a vaccine given to pregnant people to protect infants from respiratory syncytial virus (RSV), which can cause severe lung infections. The vote was unanimous based on the efficacy of the vaccine, called RSVpreF and branded Abrysvo. Ten members of the panel also...
Source: Science of Aging Knowledge Environment - May 25, 2023 Category: Geriatrics Source Type: research

Update on IMBRUVICA ® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications
HORSHAM, Pa., April 6, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics, an AbbVie Company, announced today the intent to voluntarily withdraw the U.S. indications for IMBRUVICA® (ibrutinib) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. This decision was made in consultation with the U.S. Food and Drug Administration (FDA), c...
Source: Johnson and Johnson - April 6, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

New RYBREVANT ® (amivantamab-vmjw) Data Showed Long-Term Clinical Response and Safety in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations Who Have Failed Prior Platinum-Based Chemotherapy
COPENHAGEN, DENMARK, March 29, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new long-term data from the CHRYSALIS study evaluating RYBREVANT® (amivantamab-vmjw) in patients with advanced non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on prior platinum-based chemotherapy.1 Data from the study showed long-term response and safety in this population and were presented in an oral presentation at the 2023 European Lung Cancer Congress (ELCC) (Abstract #779).1In the analysis of the CHRYSALIS study, inve...
Source: Johnson and Johnson - March 29, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Real-World Study Shows Patients Treated with IMBRUVICA ® (ibrutinib) Were Less Likely to Initiate a Next-Line Treatment than Patients on Acalabrutinib in First-line Chronic Lymphocytic Leukemia
NEW ORLEANS, December 12, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results of a real-world study showing that patients with chronic lymphocytic leukemia (CLL) treated with first-line acalabrutinib monotherapy were 89 percent more likely to start a next-line treatment than those treated with IMBRUVICA® (ibrutinib).[1] These data suggest the potential that first-line treatment with IMBRUVICA® in routine practice may provide patients with the ability to use once-daily, all-oral IMBRUVICA® as a monotherapy treatment for a longer period without the need to start the next line of ...
Source: Johnson and Johnson - December 12, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news

New Results from the Phase 3 GLOW Study of Fixed-Duration Treatment with IMBRUVICA ® (ibrutinib) Plus Venetoclax Demonstrate Robust Efficacy and Sustained Response in Older, Unfit Patients with Previously Untreated Chronic Lymphocytic Leukemia
NEW ORLEANS, December 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new four-year follow-up results from the Phase 3 GLOW study (Abstract #93), which showed investigational, fixed-duration treatment with IMBRUVICA® + venetoclax (I+V) reduced the risk of progression or death by 79 percent among older and/or unfit patients with previously untreated chronic lymphocytic leukemia (CLL) compared to patients treated with chemoimmunotherapy.[i] These results were highlighted in an oral presentation during the 2022 American Society of Hematology (ASH) Annual Meeting.1CLL is the most com...
Source: Johnson and Johnson - December 10, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news

Janssen to Highlight Latest Scientific Advances in Hematologic Diseases at ASH 2022 with Clinical and Real-World Data Across Innovative Pipeline and Distinguished Portfolio
RARITAN, N.J., November 3, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson are committed to redefining treatment outcomes in the hematology setting and today announced that abstracts from more than 50 company-sponsored studies, plus more than 20 investigator-initiated studies, will be presented at the American Society of Hematology (ASH) Annual Meeting in New Orleans from December 10-13, 2022. Janssen’s commitment to advancing an innovative portfolio of therapies for healthcare professionals and patients is evidenced through more than 70 presentations that span clinical studies and r...
Source: Johnson and Johnson - November 3, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

U.S. FDA Approves IMBRUVICA ® (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease
August 24, 2022 (HORSHAM, PA) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy. This milestone marks the first pediatric indication for IMBRUVICA® and the introduction of a new oral suspension formulation for patients ages one to less than 12. IMBRUVICA® is now the first FDA-approved therapy for these younger patients who previously had no approv...
Source: Johnson and Johnson - August 24, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

What to Know About the Monkeypox Drug TPOXX —And Why It ’ s So Hard to Get
Monkeypox, which federal officials declared a public health emergency on August 4, is not as contagious as the other ongoing public health emergency in the U.S.: COVID-19. Monkeypox primarily spreads through contact with infected skin lesions. Theoretically, containing monkeypox should therefore be more feasible, as long as testing, vaccines, and treatments are accessible. But in reality, the rollouts of all three approaches have faced major challenges. Getting the antiviral drug tecovirimat, also known as TPOXX, is particularly difficult. Here’s what to know about the antiviral drug treatment TPOXX. What is TPOXX? T...
Source: TIME: Health - August 9, 2022 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized healthscienceclimate monkeypox Source Type: news

Janssen Announces New Data Supporting Safety and Efficacy of RYBREVANT ® and Lazertinib Combination for Patients with Non-Small Cell Lung Cancer and EGFR Mutations
July 26, 2022 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 1b/2 CHRYSALIS-2 study (NCT04077463) cohort evaluating the safety and tolerability of the combination of RYBREVANT® (amivantamab-vmjw) with the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) lazertinib and platinum-based chemotherapy (carboplatin and pemetrexed) in patients with relapsed/refractory non-small cell lung cancer (NSCLC) and EGFR mutations.[1] These findings and additional updates, including data on RYBREVANT® in combination with laze...
Source: Johnson and Johnson - July 26, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news

New IMBRUVICA ® (ibrutinib) Data in Fixed-Duration Combination Regimen Presented at EHA 2022 Shows Deep, Durable Response at Three Years in Untreated Chronic Lymphocytic Leukemia
June 10, 2022 (VIENNA) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new and updated results from the Phase 2 CAPTIVATE study evaluating IMBRUVICA® (ibrutinib) in combination with venetoclax (I+V) as a potential fixed-duration (FD) treatment in adult patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Updated data from the FD cohort with three years of follow-up shows that I+V continues to demonstrate deep and durable responses and clinically meaningful progression-free survival (PFS) and overall survival (OS) in the first-line tre...
Source: Johnson and Johnson - June 10, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Presents Initial Results from the Phase 2 RAGNAR Study of BALVERSA ® (erdafitinib) in Patients with Advanced Solid Tumors with FGFR Alterations
CHICAGO, ILLINOIS, June 7, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced initial results from the pivotal Phase 2 RAGNAR study evaluating the investigational use of BALVERSA® (erdafitinib), a fibroblast growth factor receptor (FGFR) kinase inhibitor, in patients with advanced solid tumors with prespecified FGFR alterations. At a planned interim analysis (IA), responses were observed across a variety of FGFR-driven solid tumors for patients who had exhausted standard treatment options prior to being treated with BALVERSA®.[1] These results will be featured in an oral presentation (...
Source: Johnson and Johnson - June 7, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Phase 3 SHINE Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen Significantly Reduced the Risk of Disease Progression or Death in Older Patients with Newly Diagnosed Mantle Cell Lymphoma
This study is one of the largest clinical trials ever conducted in first-line MCL and the first for a Bruton’s tyrosine kinase inhibitor (BTKi).[1] The data are being presented in an oral session and featured in a press briefing during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and were published in The New England Journal of Medicine today. The data will also be presented as an oral presentation at the 2022 European Hematology Association (EHA) Annual Congress. MCL is a type of aggressive, rare non-Hodgkin lymphoma (NHL) that is incurable and difficult to treat.[2] It commonly affects people o...
Source: Johnson and Johnson - June 3, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen to Highlight Science, Innovation and Advances in Robust Oncology Portfolio and Pipeline Through More Than 60 Data Presentations at ASCO and EHA
RARITAN, N.J., May 31, 2022 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that new research and data from its robust oncology portfolio and pipeline of investigational therapies will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 3-7 in Chicago, and the European Hematology Association (EHA) 2022 Congress taking place in Vienna, Austria, June 9-12. More than 60 presentations from company-sponsored studies across the two congresses, including 14 oral presentations, will feature new data and updates for both approved and investigation...
Source: Johnson and Johnson - May 31, 2022 Category: Pharmaceuticals 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

New Data from Phase 3 GLOW Study Show Fixed-Duration Treatment with IMBRUVICA ® (ibrutinib) Plus Venetoclax Demonstrated Deeper and Sustained Undetectable Minimal Residual Disease Outcomes in First-Line Chronic Lymphocytic Leukemia
ATLANTA, Ga., December 11, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from two studies evaluating the efficacy and safety of IMBRUVICA® (ibrutinib) plus venetoclax (I+V) as a potential fixed-duration treatment in adult patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These data were both featured today during the American Society of Hematology (ASH) 2021 Annual Meeting. New secondary endpoint data from the Phase 3 GLOW study (NCT03462719) showed that fixed-duration treatment with I+V resulted in undetectable min...
Source: Johnson and Johnson - December 11, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news