Search Results for “Janssen” – Page 4 – media

Legend Biotech’s “CARVYKTI®” was approved for second-line indications in the United States

Recently, Legend Biotech announced in Somerset, New Jersey, that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (cilta-cel) for the treatment of relapsed or refractory multiple myeloid(RRMM) patients who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), and are resistant to lenalidomide1. CARVYKTI® is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for second-line treatment of multiple myeloma patients, including CAR-T therapy, bispecific antibodies and antibody-drug conjugates (ADCs). The FDA’s approval is based on positive results from the CARTITUDE-4 study, which showed that compared with pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (PVd), DPd) these two standard treatment regimens, CARVYKTI® can significantly improve the progression-free survival (PFS) of adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received first- to third-line treatment. This result has statistical and clinical significance. The approval ...
- Source: drugdu
- 107
- April 8, 2024
‘Top-down’ treatment strategy dramatically improves outcomes for Crohn’s patients

Researchers from the University of Cambridge have revealed a ‘top-down’ treatment strategy involving Janssen’s Remicade (infliximab) straight after diagnosis significantly improved outcomes for patients with Crohn’s disease. Affecting around one in 350 people in the UK, Crohn’s disease is a life-long condition caused by inflammation of the digestive tract, which can lead to flares of inflammation and progressive bowel disease damage as the condition worsens. Sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, with support from the National Institute for Health and Care Research (NIHR), the PROFILE trial recruited 386 Crohn’s disease patients from 40 hospitals across the UK. Despite the biomarker not proving useful in selecting treatments for individual patients, patients were randomly assigned to one of two treatment groups, which were given a different treatment strategy: ‘accelerated step-up’ or ‘top-down’. The accelerated step-up group treatment approach involved patients starting Remicade if their disease ...
- Source: drugdu
- 134
- March 2, 2024
FDA Approves Imbruvica Label Expansion to Include Oral Suspension Formulation

Don Tracy, Associate Editor New label marks the first Bruton’s tyrosine kinase inhibitor to be approved with an oral suspension formulation. The FDA has approved an addendum to the Imbruvica (ibrutinib) label to include an oral suspension formulation across the drug’s indications. Johnson & Johnson (J&J), in partnership with Pharmacyclics LLC, an AbbVie Company, announced that the new formulation is approved to treat patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) following the failure of one or more lines of systemic therapy. This option is designed for patients who have difficulty swallowing pills, part of J&J’s ongoing efforts to provide multiple patient-friendly treatment options, the company stated in a press release.1 “As the most comprehensively studied therapy in its class, Imbruvica has helped change the standard of care for adults living with certain blood cancers and cGVHD. Nearly 300,000 ...
- Source: drugdu
- 131
- February 29, 2024
Changing protocol language and site actions are key to making trials inclusive

Changing the language used in trial protocols and continually conversing with sites are some ways by which trialists can make clinical research more inclusive of the LGBTQIA+ community, say experts. On the fourth and final day of the 2024 Summit for Clinical Ops Executives (SCOPE) Summit held in Orlando, a panel discussed the most important changes that can make clinical trials more inclusive of the community. Shir Netanel, associate director of patient advocacy and clinical trial advocacy for Janssen, spoke about her experience with the company launching a transgender-inclusive Phase III trial for prostate cancer. Netanel mentioned how changing the language to be gender neutral, for example, allowed the protocol and eligibility criteria to include any patients who are affected with prostate cancer, regardless of their gender. Additionally, Janssen has also created and deployed a toolkit at trial sites to help investigators be more inclusive, she added. Michel Reid, head ...
- Source: drugdu
- 98
- February 16, 2024
Key Trends from the 2024 J.P. Morgan Healthcare Conference

Key trends such as the resilience of the emerging biopharma space, the complexities of Medicare, and the revolutionary role of data and AI are shaping the future of the industry. By SUJAY JADHAV Beneath the Californian sunshine (and a few showers) at JP Morgan, a revolution simmers. Not a political one, but a healthcare revolution propelled by necessity and fueled by innovation. Imagine a future where groundbreaking therapies reach patients years sooner, personalized treatments offer hope for chronic diseases, and healthcare costs become more manageable for everyone. This isn’t science fiction; it’s the promise of the cutting-edge trends made at the annual J.P. Morgan Healthcare Conference earlier this month. For those that attended JPM in early 2023, you may recall it was quite gloomy coming off of a soft 2022 and an interest rate burdened 2023. JPM 2024 had an air of optimism. Emerging biopharma space: Challenges and innovations One ...
- Source: drugdu
- 89
- January 27, 2024
FDA opens investigation into secondary cancer risk with CAR-T therapies

The US Food and Drug Administration (FDA) has started an investigation to review the safety of chimeric antigen receptor (CAR)-T cell immunotherapies following reports of T cell malignancies in patients who received these immunotherapies. The therapies under investigation include six approved B cell maturation antigen (BCMA)- or CD19-directed CAR-T cell therapies. The investigation follows reports collected from clinical trials and post-marketing adverse event surveillance. The FDA had required companies to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies as part of the respective therapy’s approval. The risk of post-therapy malignancies applies to all FDA-approved BCMA- or CD19-directed CAR-T cell therapies, as per a 28 November press release. The agency added that although the therapy benefits “continue to outweigh their potential risks for their approved uses”, the FDA is evaluating the need for regulatory action regarding the risk of T-cell ...
- Source: drugdu
- 97
- December 1, 2023
FDA Launches Probe of Malignancies Linked to CAR-T Therapies

By Tyler Patchen Pictured: Exterior of an FDA building/iStock, Grandbrothers The FDA announced Tuesday that it is investigating the “serious risk” of malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies. The regulator said it has determined that the risk of T-cell malignancies “is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies” including Bristol Myers Squibb’s Abcema and Breyanzi, Johnson & Johnson’s Carvykti, Novartis’ Kymriah and Gilead’s Tecartus and Yescarta. “T-cell malignancies have occurred in patients treated with several products in the class,” according to the FDA, which said it received reports from clinical trials and postmarketing adverse event data. While the agency said that the overall benefits of these products continue to outweigh their potential risks, it “is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the ...
- Source: drugdu
- 113
- November 30, 2023
Novartis Enters into Deal with Legend Biotech for $100 Million Upfront

By Tyler Patchen Legend Biotech has secured an exclusive global license deal with Novartis giving the Swiss pharma access to Legend’s CAR-T cell therapies. The deal announced on Monday will give Novartis access to CAR-Ts that target the delta-like ligand protein (DLL3) candidate LB2102, which Legend has been investigating to treat adults with certain small cell lung cancers. Novartis will pay Legend $100 million upfront, and the New Jersey–based biotech “will be eligible to receive up to $1.01 billion in clinical, regulatory and commercial milestone payments and tiered royalties,” according to the company’s announcement. The deal has Legend taking the lead on the Phase I trials for LB2102 in the U.S., while Novartis will handle all other development. No hard date has been given as to when the deal will close. For its part, Novartis will receive exclusive worldwide rights to develop, produce and eventually commercialize the therapies. The company ...
- Source: drugdu
- 106
- November 15, 2023
NRx and Nephron join hands to formulate ketamine for depression

NRx Pharmaceuticals and Nephron Pharmaceuticals have come together in a bid to develop the first FDA-approved intravenous ketamine treatment for suicidal depression. The partnership will see NRx developing the drug while giving Nephron the responsibility of manufacturing the product. As per chief scientist and director Dr. Jonathan Javitt, NRx aims to deliver a two-year shelf-stable ketamine formulation to patients by November 2024. Nephron is in the process of setting the stage for submitting an New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the drug. The target deadline for filing the application is 1 March, 2024, said Nephron CEO Lou Kennedy. According to the US Centers for Disease Control and Prevention (CDC), suicide rates have risen by approximately 36% from 2000-2021, with suicide being the second leading cause of death in 2021 for individuals in the age groups of 10 –14 years and 20 –34 years. ...
- Source: drugdu
- 101
- November 8, 2023
CHMP recommends European authorisation for seven new drugs

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new drugs for authorisation. The drugs include Pfizer’s Elrexfio for the treatment of multiple myeloma and Astellas Pharma’s Veozah for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Elrexfio (elranatamab) is a subcutaneously administered bispecific B-cell maturation antigen-directed CD3 T-cell engager. The US Food and Drug Administration (FDA) granted accelerated approval for Elrexfio in August for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. According to GlobalData, sales for Elrexfio are expected to reach $536m by 2029. One of its competitors in the market is Talvey (talquetamab-tgvs), marketed by Janssen, which was approved as a fifth-line treatment for relapsed/refractory multiple myeloma in August. Talvey is forecasted to generate $1.9bn in sales by 2029. Astellas Pharma’s Veozah ...
- Source: drugdu
- 111
- October 19, 2023

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