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Keep up with the regulator's latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
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IMF Medical Student Scholars for Health Equity in Myeloma Present Research at the 2023 NMA Annual Convention & Scientific Assembly
9/7/2023
The International Myeloma Foundation, in partnership with the National Medical Association, the W. Montague Cobb Institute, and the Student National Medical Association, sent a delegation of eleven IMF Medical Student Scholars for Health Equity in Myeloma along with their mentors to the 2023 NMA Annual Convention and Scientific Assembly, which took place in New Orleans, LA from July 29-August 2, 2023.
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Talvey Talquetamab Gets FDA Approval For Multiple Myeloma
8/17/2023
Johnson & Johnson’s subsidiary Janssen made headlines again in August 2023 when the FDA approved its product talquetamab under the agency’s accelerated approval program.
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On the heels of J&J’s Talvey, Pfizer’s bispecific antibody Elrexfio has secured an accelerated approval as another off-the-shelf treatment option for patients with relapsed or refractory multiple myeloma.
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J&J’s Janssen Pharmaceutical got the FDA’s greenlight Friday for its PARP inhibitor Akeega, which is now authorized to treat BRCA-mutated metastatic castration-resistant prostate cancer.
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FDA Roundup: August 11, 2023
8/11/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Despite being heavily pretreated, patients on J&J’s Talvey saw a 73.6% overall response rate in a Phase II study, winning accelerated approval from the regulator.
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U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma
8/10/2023
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. FDA has granted accelerated approval of TALVEY™, a first-in-class bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
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Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma
6/3/2023
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the pivotal Phase 1/2 MonumenTAL-1 study of the investigational bispecific antibody talquetamab in the treatment of patients with relapsed or refractory multiple myeloma.
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Janssen Presents First-Ever Results from Dual Bispecific Combination Study Showing 96 Percent Overall Response Rate in Patients with Relapsed or Refractory Multiple Myeloma
6/3/2023
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the first-ever results from the Phase 1b RedirecTT-1 study of TECVAYLI®, a first-in-class BCMAxCD3 bispecific antibody, and talquetamab, a first-in-class GPRC5DxCD3 bispecific antibody, showing a high overall response rate among patients with relapsed or refractory multiple myeloma.
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Fresh off of his Sanofi exit, John Reed is joining Johnson & Johnson, where he will serve as executive vice president, pharmaceuticals, R&D.
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Johnson & Johnson Reports Q4 and Full-Year 2022 Results
1/24/2023
Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full year 2022.
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Research Highlights Cutting-Edge New Treatments for Blood Disorders
12/10/2022
New research being presented at the 64th American Society of Hematology Annual Meeting and Exposition focuses on a variety of approaches for several hematologic diseases to improve outcomes and quality care.
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Janssen Presents New Data for Talquetamab, a First-in-Class GPRC5DxCD3 Bispecific Antibody, Suggesting Durable Responses in Patients with Heavily Pretreated Multiple Myeloma
12/10/2022
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1/2 MonumenTAL-1 study of talquetamab, an investigational, off-the-shelf, bispecific T-cell engager antibody.
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Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
12/9/2022
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma.
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Janssen to Highlight Latest Scientific Advances in Hematologic Diseases at ASH 2022 with Clinical and Real-World Data Across Innovative Pipeline and Distinguished Portfolio
11/3/2022
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.
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In honor of World Cancer Research Day, Sept. 24, BioSpace spoke with Elevation Oncology, Janssen, Merck and Teclison to learn more about the latest innovations in immuno-oncology.
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Johnson & Johnson Reports Q2 2022 Results
7/19/2022
Johnson & Johnson announced results for second-quarter 2022. “Our solid second quarter results across Johnson & Johnson reflect the strength and resilience of our Company’s market leadership in the midst of macroeconomic challenges,” said Joaquin Duato, Chief Executive Officer.
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Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients with Multiple Myeloma
6/10/2022
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1 MonumenTAL-1 first-in-human dose-escalation study of talquetamab (NCT03399799).
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Janssen to Highlight Science, Innovation and Advances in Robust Oncology Portfolio and Pipeline Through More Than 60 Data Presentations at ASCO and EHA
5/31/2022
The Janssen Pharmaceutical Companies of Johnson & Johnson announced 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 Annual Meeting, taking place June 3-7 in Chicago, and the European Hematology Association 2022 Congress taking place in Vienna, Austria, June 9-12.