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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

Fight Aging! Newsletter, May 1st 2023
In conclusion, frailty progression accelerates in males with one LTCs and females with two LTCs or more. Health providers should be aware of planning a suitable intervention once the elderly have two or more health conditions. Plasma Transfer Lowers Epigenetic Age and Mortality in Rats https://www.fightaging.org/archives/2023/04/plasma-transfer-lowers-epigenetic-age-and-mortality-in-rats/ Plasma transfer from young to old individuals has produced mixed results in animals and little to no benefit in humans where assessed rigorously. These studies were driven by the hypothesis that young plasma contains me...
Source: Fight Aging! - April 30, 2023 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs

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

New STELARA ® (ustekinumab) Long-Term Data Support its Established Safety Profile in Inflammatory Bowel Disease and Durable Efficacy in Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, March 4, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final pooled long-term safety results for STELARA® (ustekinumab) through five years in adults with moderately to severely active Crohn’s disease (CD) and four years in adults with moderately to severely active ulcerative colitis (UC), as well as final four-year clinical and endoscopic outcomes from the UNIFI long-term extension (LTE) study evaluating the efficacy of STELARA for the treatment of adults with moderately to severely active UC.1,2 These data are a part of Janssen’s 22 oral and poster ...
Source: Johnson and Johnson - March 4, 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

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

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 TECVAYLI ™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
HORSHAM, Pa., October 25, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved TECVAYLI™ (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.1 TECVAYLI™ is a first-in-class, bispecific T-cell engager antibody that is administered as a subcutaneous treatment.1 This off-the-shelf (or ready to use) therapy uses innovative science to ac...
Source: Johnson and Johnson - October 25, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

STELARA ® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults with Moderately to Severely Active Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final data from the long-term extension (LTE) of the Phase 3 UNIFI study demonstrating efficacy and safety of STELARA® (ustekinumab) through four years of treatment in adult patients with moderately to severely active ulcerative colitis (UC).1 Among all patients who had achieved clinical responsea with STELARA during induction, 64.9 percent were in symptomatic remissionb after 44 weeks of maintenance. At week 200 (four years), this proportion of patients was 55.2 percent; the majority (96.4 percen...
Source: Johnson and Johnson - October 10, 2022 Category: Pharmaceuticals Source Type: news

Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults with Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of Clinical, Histologic, and Endoscopic Remission at Week 38
SPRING HOUSE, PENNSYLVANIA, October 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from an ongoing analysis of a Phase 2a clinical trial showing adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a clinical remission ratea (based on the modified Mayo score [mMayo])b at week 38 of 47.9 percent, a higher rate than induction and maintenance treatment with either guselkumab alone (31.0 percent) or golimumab al...
Source: Johnson and Johnson - October 10, 2022 Category: Pharmaceuticals Source Type: news

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