Search Results for “antibody” – Page 21 – media

Sarclisa Combination Improves Progression-Free Survival in Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma

Don Tracy, Associate Editor Reportedly, data from the IMROZ study marks the first time an anti-CD38 monoclonal antibody combined with standard-of-care therapy has demonstrated significant improvement in progression-free survival for newly diagnosed transplant-ineligible multiple myeloma. Results from the IMROZ Phase III trial show that Sanofi’s Sarclisa (isatuximab-irfc) in combination with standard-of-care therapy comprised of lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death by 40% compared to a solo VRd regimen in patients with newly diagnosed transplant-ineligible multiple myeloma (MM). According to the company, the data represents the first time an anti-CD38 monoclonal antibody combined with VRdsupported a significant improvement in progression-free survival (PFS) for these patients. “The significant progression-free survival (PFS) benefit observed with Sarclisa combination therapy compared to VRd is important and encouraging for patients with newly diagnosed multiple myeloma. Effective frontline therapy has the potential to modify the course of the disease, which ...
- Source: drugdu
- 69
- July 1, 2024
Level Up Your Self Love, Check Your Status

Don Tracy, Associate Editor As a part of National HIV Testing Day, the Centers for Disease and Control Prevention encourages testing as a part of taking charge of individual health and wellness. Today is National HIV Testing Day (NHTD) and as part of this year’s theme, “Level up your self-love: check your status,” individuals across the United States are being encouraged to get tested to show value, respect, and compassion for each other by taking charge of our health and wellness, according to the Centers for Disease and Control Prevention (CDC). “HIV testing is an essential entry point for services such as PrEP for those without HIV, and HIV treatment for those who have HIV,” reports the CDC. “Testing programs have been critical contributors to the 12% decrease in estimated HIV infections from 2018 to 2022, and a major factor contributing to ongoing disparities in HIV is a lack of ...
- Source: drugdu
- 96
- June 29, 2024
Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy

The US Food and Drug Administration (FDA) has approved Verona Pharma’s Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is an inhaled dual inhibitor of phosphodiesterase 3 and phosphodiesterase 4 enzymes and has bronchodilator and non-steroidal anti-inflammatory effects. Verona plans to launch the therapy in Q3 this year. “With substantial funding of up to $650m secured, Verona Pharma is well-positioned to distribute Ohtuvayre in the US, ensuring its availability even beyond 2026,” said Asiyah Nawab, Pharma Analyst at GlobalData. The Ohtuvayre approval was based on the positive results from Phase III ENHANCE-1 and ENHANCE-2 trials (NCT04535986 and NCT04542057). The data from the pooled analysis of the studies showed significant improvements in the symptoms of COPD exacerbations, including dyspnea, breathlessness, cough, sputum, and chest symptoms, in patients with moderate to severe COPD. Ohtuvayre is expected to generate global sales of $1.1bn by 2029, ...
- Source: drugdu
- 89
- June 29, 2024
Fosun Pharma to Privatize Henlius for $5.407 Billion, Integrate Innovative Assets to Further Focus on Pharmaceutical Business

On June 24, 2024, Fosun Pharma (600196.SH; 02196.HK) announced that it intends to privatize its subsidiary, Henlius (02696.HK), through a merger by absorption. The cash consideration for this absorption and merger transaction is HK$24.6 per share, which is a premium of 36.67% to the closing price of Henlius H shares on the undisturbed date; and a premium of 52.04% to the 30 trading days prior to the undisturbed date. The aggregate cash consideration for the Merger by Absorption shall not exceed approximately HK$5,407 million or its equivalent in RMB. As a core innovative asset of Fosun Pharma, Fuhong Henlius, upon completion of the transaction, will contribute to the sustainable growth of Fuhong Henlius as well as strengthen Fosun Pharma’s strategic layout in the field of innovative biopharmaceuticals. Henlius, as an international innovative biopharmaceutical company, is committed to providing affordable and high-quality biopharmaceuticals to patients around the world, with products covering ...
- Source: drugdu
- 128
- June 27, 2024
FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP

Argenx’s Vyvgart Hytrulo is now approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disease that affects nerves and impairs muscle function. The drug, an FcRn inhibitor, is the first in its class to win FDA approval in CIDP. By Frank VinluanA blockbuster Argenx therapy now has an additional FDA approval as a treatment for a rare autoimmune disorder affecting nerves, marking the first new treatment for this condition in decades and a new blockbuster opportunity for this pipeline-in-a-product drug. The disease, chronic inflammatory demyelinating polyneuropathy, or CIDP, develops as the immune system attacks myelin, the protective covering of nerve fibers. CIDP leads to weakness and impairment of motor function, numbness and tingling, and difficulty walking. In many cases, the loss of muscle function requires patients to rely on a wheelchair for mobility. The FDA’s late Friday approval of the Argenx product, Vyvgart Hytrulo, covers the treatment of ...
- Source: drugdu
- 98
- June 26, 2024
AbbVie and Future Gen Biopharm Announce License Agreement to Co-Develop Next Generation Inflammatory Bowel Disease Therapies

On June 13, 2010, AbbVie and Future Gen Biopharm announced the signing of a license agreement to co-develop FG-M701, a next-generation TL1A antibody in preclinical development for the treatment of inflammatory bowel disease (IBD). FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target for inflammatory bowel disease. Uniquely engineered to have potentially best-in-class functional properties compared to first-generation TL1A antibodies, FG-M701 is designed to provide improved efficacy and reduced dosing frequency in the treatment of inflammatory bowel disease. Dr. Jonathon Sedgwick, Senior Vice President and Global Head of Discovery Research at AbbVie, said that the prevalence of inflammatory bowel disease continues to rise, and many people with ulcerative colitis and Crohn’s disease do not respond to current therapies. AbbVie’s mission is to raise the standard of care by pursuing transformative therapies to help more patients with autoimmune diseases achieve remission. We look forward to working with ...
- Source: drugdu
- 116
- June 17, 2024
Avidity Bio’s RNA Therapy Flashes Early Signs of Treating a Muscular Dystrophy’s Root Cause

Avidity Biosciences’ RNA therapy for facioscapulohumeral muscular dystrophy has preliminary clinical data showing it knocked down expression of a gene that causes this rare disease. More details will be presented at a medical conference this week. By Frank VinluanAn experimental RNA therapy from Avidity Biosciences has early clinical trial results showing it reduced by half the expression of a gene at the root of a rare, inherited form of muscular dystrophy with no FDA-approved therapies. Furthermore, patients in the study are showing signs of regaining muscle function. Based on these initial results announced Wednesday, Avidity said it plans to accelerate the start of additional cohorts in the Phase 1/2 study that could support an application seeking regulatory approval in this disease, facioscapulohumeral muscular dystrophy (FSHD). More details about the data are coming soon. Avidity plans to present the preliminary results during the Annual FSHD Society International Research Congress meeting, which ...
- Source: drugdu
- 79
- June 14, 2024
Innovent Receives Fast Track Designation from the U.S. FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer

SAN FRANCISCO and SUZHOU, China, June 13, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its TOPO1i anti-CLDN18.2 ADC (R&D code: IBI343), for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. Previously, IBI343 has already received FDA approval of its IND application for the treatment of PDAC. At the ASCO 2024 Annual Meeting, Innovent reported the preliminary Phase 1 results of IBI343 in advanced PDAC patients who have received at least one prior line of treatment. In the 6 mg/kg dose group, among the 10 evaluable PDAC patients with CLDN18.2 1/2/3+≥60%, the overall response ...
- Source: drugdu
- 72
- June 14, 2024
FDA Approves Regeneron and Sanofi’s Kevzara to Treat Patients with Active Polyarticular Juvenile Idiopathic Arthritis

Don Tracy, Associate Editor Approval for Kevzara was based on controlled studies, pharmacokinetic data from adults with rheumatoid arthritis, and pediatric-specific studies on pharmacokinetics. The FDA has approved Regeneron’s and Sanofi’s approved Kevzara (sarilumab) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing over 138 lbs. According to a joint press release, the approval was based on results of controlled studies and pharmacokinetic data from adults with rheumatoid arthritis (RA), as well as pediatric-specific studies on pharmacokinetics, pharmacodynamics, dosing, and safety.1 “Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, in a press release. “Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment. The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable ...
- Source: drugdu
- 155
- June 13, 2024
AbbVie’s Telisotuzumab Vedotin (Teliso-V) Included in CDE’s List of Breakthrough Therapeutic Varieties

Recently, the Center for Drug Evaluation (CDE) of the State Drug Administration formally included AbbVie’s clinically developed sterile lyophilized powder for infusion, Telisotuzumab Vedotin (Teliso-V), into the list of breakthrough therapeutic drug varieties for the treatment of advanced/late stage c-Met protein (OE) with high expression of c-Met protein (OE) with disease progression occurring during or after platinum-based drug therapy. metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq) non-small cell lung cancer (NSCLC) patients. About Telisotuzumab Vedotin (Teliso-V) Teliso-V is an investigational first-in-class antibody-coupled drug (ADC) targeting the c-MET protein in patients with tumors overexpressing c-Met, a receptor tyrosine kinase that is overexpressed in many solid tumors, including NSCLC. Its efficacy safety as monotherapy in previously treated patients with c-Met overexpressing NSCLC will be further evaluated in the randomized Phase 3 study TeliMET NSCLC-01 (Study M18-868) For more information on the Teliso-V clinical trial, please visit https://clinicaltrials.gov/. Currently, there ...
- Source: drugdu
- 121
- June 13, 2024

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