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Total 188 results found since Jan 2013.
TREMFYA ® (guselkumab) Provides Sustained Improvements Across All Minimal Disease Activity Domains for Adults Living with Active Psoriatic Arthritis in Phase 3b Trial
SPRING HOUSE, PENNSYLVANIA, May 31, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 3b COSMOS clinical trial showing that treatment with TREMFYA® (guselkumab) provided sustainable improvements in all minimal disease activity (MDA)a domains through week 48 in adults living with active psoriatic arthritis (PsA) who previously had an inadequate response to one to two tumor necrosis factor inhibitors (TNFi-IR).[1] In a separate post-hoc analysis of the Phase 3 DISCOVER-1 and DISCOVER-2b clinical trial findings, TREMFYA was shown to be associated with prompt and su...
Source: Johnson and Johnson - May 31, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
RARITAN, NJ, May 30, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients with WHO functional class (FC) II-III.[1] The application is based on positive data from the Phase 3 A DUE study, which met its primary endpoint and demonstrated that M/T STCT si...
Source: Johnson and Johnson - May 30, 2023 Category: Pharmaceuticals Source Type: news
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
Janssen to Highlight Scientific Advances and Commitment to Transform Cancer Care at ASCO and EHA with More than 90 Presentations Showcasing Robust, Differentiated Portfolio and Pipeline in Hematologic Malignancies and Solid Tumors
This study evaluates an investigational combination regimen of IMBRUVICA® (ibrutinib) plus venetoclax (I+V) for newly diagnosed chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), (Abstracts #7535 and #P617, respectively).Advancing the Science of Solid Tumors Through Precision MedicineJanssen’s continued innovation in solid tumors focuses on advancing precision medicine options for patients with biomarker-driven disease who have limited targeted treatment options and moving patients into earlier lines of therapy when treatments may be more effective. Lung CancerAn oral presentation will report ...
Source: Johnson and Johnson - May 18, 2023 Category: Pharmaceuticals Tags: Innovation Source Type: news
The Pandemic Didn ’ t Really Change How Americans Think About Sickness
Thomas McDade, a biological anthropologist at Northwestern University, still remembers an advertisement for cold medicine he saw in late 2019. The ad showed a visibly sick businessman walking through an airport, “and the message was, ‘You can solider through this. You can make it,'” McDade says.
That message didn’t age well. Only a few months later, the virus that causes COVID-19 began spreading across the globe, prompting health officials to beg people to stay home no matter what—but especially if they felt sick. Suddenly, soldiering through an illness wasn’t seen as admirable, but irre...
Source: TIME: Health - May 15, 2023 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news
TWiV 1004: Clinical update with Dr. Daniel Griffin
In his weekly clinical update, Dr. Griffin discusses the U.S. Food and Drug Administration approving Arexvy: the first respiratory syncytial virus (RSV) vaccine approved for use in the United State, association between SARS-CoV-2 and metagenomic content of samples from the Huanan Seafood Market, researchers disagree over how bad it is to be reinfected and whether COVID-19 can cause lasting changes to the immune system, virtual care and emergency department use during the COVID-19 pandemic among patients of family physicians in Canada, vaccination with BCG-Denmark did not result in a lower risk of COVID-19 among healt...
Source: This Week in Virology - MP3 Edition - May 6, 2023 Category: Virology Authors: Vincent Racaniello Source Type: podcasts
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
TREMFYA ® (guselkumab) Real-World Data Analyses Show Greater Treatment Persistence Than IL-17s in Both Bio-naïve and Bio-experienced Patients Living With Moderate to Severe Plaque Psoriasis
SPRING HOUSE, PENNSYLVANIA, March 17, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data, showing that initiation of TREMFYA® (guselkumab) was associated with greater treatment persistencea compared to secukinumab or ixekizumab in bio-naïve and bio-experienced patientsb living with moderate to severe plaque psoriasis (PsO), based on pairwise analysesc of real-world data.[1],[2] Additionally, in a post-hoc analysis of Phase 3 VOYAGE 2 clinical trial results, TREMFYA demonstrated durable clinical efficacy, itch relief and quality-of-life improvements in patients living with scal...
Source: Johnson and Johnson - March 17, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
New ‐onset retroperitoneal fibrosis following COVID‐19 mRNA vaccination: Coincidental or vaccine‐induced phenomenon?
AbstractThe Pfizer-BioNTech mRNA vaccine is a US Food and Drug Administration-approved coronavirus disease 2019 (COVID-19) vaccine. Although it is reported to be safe and effective, immune dysregulation leading to autoimmunity has become an area of concern. Retroperitoneal fibrosis (RPF) is an immune-mediated fibroinflammatory disease characterized by the deposition of fibrous tissues, primarily around the abdominal aorta and iliac arteries. Herein, we report a case of RPF following Pfizer BioNTech COVID-19 mRNA vaccination. To the best of our knowledge, there have been no published reports on RPF after COVID-19 mRNA vacci...
Source: International Journal of Rheumatic Diseases - February 23, 2023 Category: Rheumatology Authors: Hirut Yadeta Ture,
Na Ri Kim,
Eon Jeong Nam Tags: CASE REPORT Source Type: research
Opioid Antidote Narcan May Soon Be Sold Over the Counter
WASHINGTON — The overdose-reversing drug naloxone should be made available over the counter to aid the national response to the opioid crisis, U.S. health advisers said Wednesday.
The panel of Food and Drug Administration experts voted unanimously in favor of the switch after a full day of presentations and discussions centered on whether untrained users would be able to safely and effectively use the nasal spray in emergency situations.
The positive vote, which is not binding, came despite concerns from some panel members about the drug’s instructions and packaging, which caused confusion among some people in ...
Source: TIME: Health - February 16, 2023 Category: Consumer Health News Authors: Matthew Perrone/AP Tags: Uncategorized Drugs healthscienceclimate wire 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
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
Janssen Presents Efficacy and Subgroup Analyses from MAIA Study Showing Long-Term Results of DARZALEX ® (daratumumab)-based Regimen in Newly Diagnosed, Transplant-Ineligible Multiple Myeloma
NEW ORLEANS, December 12, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new analyses from the Phase 3 MAIA study of DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone (D-Rd), evaluating progression-free survival (PFS), minimal residual disease (MRD) negativity and overall response rate (ORR) at a median follow-up of 64.5 months, and overall survival (OS) at a median follow-up of 73.6 months in newly diagnosed, transplant-ineligible (TIE) patients with multiple myeloma, regardless of patients’ age and across clinically important subgroups, as well as health...
Source: Johnson and Johnson - December 12, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Janssen Presents First Data from MajesTEC-2 Trial of TECVAYLI ™ (teclistamab-cqyv) in Combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and Lenalidomide in Relapsed or Refractory Multiple Myeloma
NEW ORLEANS, December 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new results from a cohort of the Phase 1b MajesTEC-2 study of TECVAYLI™ (teclistamab-cqyv), a first-in-class, BCMAxCD3 bispecific T-cell engager antibody, in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and lenalidomide. According to the results, the immune-based triplet therapy regimen had a manageable safety profile with no unexpected safety signals observed. A very good partial response (VGPR) or better was achieved by 90.3 percent of patients with relapsed or refractory multiple ...
Source: Johnson and Johnson - December 10, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
