Search Results for “Clinical Trial” – Page 57 – media

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
- 68
- June 14, 2024
Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease

Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer. By Frank VinluanA rare liver disease that can progress to organ failure now has a new FDA-approved therapy, a drug from Ipsen that brings a novel approach to treating the chronic condition. The Ipsen drug, elafibranor, treats primary biliary cholangitis (PBC). The regulatory decision announced late Monday makes the drug just the third approved therapy for the chronic liver disorder, but competition in this indication is heating up. Paris-based Ipsen will market its new product under the brand name Iqirvo. PBC is an autoimmune condition in which bile and toxins build up in the liver, leading to inflammation and damage to ...
- Source: drugdu
- 124
- 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
- 110
- June 13, 2024
FDA Approves GSK’s Arexvy to Prevent Respiratory Syncytial Virus in Adults Aged 50-59 with Increased Risk

Don Tracy, Associate Editor Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease. GSK’s Arexvy (RSV Vaccine, Adjuvanted) has been approved by the FDA for an expanded indication to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in adults aged 50-59 years with an increased risk. The approval for this age group was based on encouraging results from a Phase III trial (NCT05590403) that evaluated the immune response and safety of Arexvy in adults aged 50-59, including those with underlying medical conditions. Arexvy was previously approved for adults aged 60 years and older for the same purpose in May 2023. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommended its use through shared clinical decision-making.1 “[This] approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. For those ...
- Source: drugdu
- 97
- June 12, 2024
FDA Committee Votes Against Approval of Lykos Therapeutics’ MDMA Treatment for PTSD

Don Tracy, Associate Editor In a majority vote, the Psychopharmacologic Drugs Advisory Committee cited concerns regarding the data presented for MDMA as a treatment for post-traumatic stress disorder. The FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) has voted against recommending Lykos Therapeutics’ New Drug Application (NDA) for midomafetamine (MDMA) capsules for use in combination with psychological intervention for the treatment of post-traumatic stress disorder (PTSD) in adults. The committee voted 2-to-9 against the efficacy of the treatment, and voted 1-to-10 against the benefits outweighing the risks, stating its doubts that MDMA-assisted therapy is effective in treating PTSD.1 “We are disappointed in today’s vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” said Amy Emerson, CEO, Lykos Therapeutics, in a press release. As a basis of their ...
- Source: drugdu
- 74
- June 11, 2024
Data Presented at ASCO Show Improved Complete Response with Jemperli as a First-Line Treatment for Locally Advanced Rectal Cancer in Patients with Mismatch Repair Deficient Status

Don Tracy, Associate Editor Results of the Phase II AZUR-1 trial show that 100% of participants achieved a clinical complete response when treated with Jemperli for locally advanced rectal cancer in patients with mismatch repair deficient status. Updated results from the Phase II AZUR-1clinical trial of Jemperli (dostarlimab) show the promise of the medication as a treatment for mismatch repair deficient (dMMR) locally advanced rectal cancer in offering an alternative to surgery, according to GSK. The trial, performed in partnership with Memorial Sloan Kettering Cancer Center (MSK), found that Jemperli produced a 100% clinical complete response (cCR) in participants administered the drug, according to data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.1 “The data showing no evidence of disease in 42 patients is remarkable. These results bring us one step closer to understanding the potential of dostarlimab in this curative-intent setting for patients with dMMR ...
- Source: drugdu
- 98
- June 6, 2024
Molecular Profiling Improves Diagnosis for Children with High Risk Cancers

Cancer remains the leading cause of disease-related death among children in most developed nations, and approximately one-fourth of these patients are diagnosed with aggressive, high-risk, or relapsed cancers, facing a dismal five-year survival rate of under 30%. Diagnosing these conditions accurately can be challenging, and even survivors often endure lifelong side effects from the harsh treatments required for their recovery. Now, researchers have demonstrated that through precision medicine, not only can diagnoses be more accurate, but implementing precision-guided, targeted treatments earlier can also enhance the two-year progression-free survival rates for young cancer patients. The Zero Childhood Cancer National Precision Medicine Program (ZERO) (Randwick, Australia), initially aimed at children with high-risk cancers, now includes all young cancer patients in Australia. Since its inception in 2017, the program has enrolled over 1,600 children. ZERO’s inaugural clinical trial, which ran from 2017 to 2022, yielded insights into genetic predispositions to cancer by identifying ...
- Source: drugdu
- 86
- June 5, 2024
Virtual Therapeutics, Akili Interactive Strike Definitive Merger Agreement Seeking to Improve Mental Health Through Immersive Video Games

Don Tracy, Associate Editor Under terms of the deal, Akili will become a wholly owned subsidiary of Virtual Therapeutics, with Akili shareholders receiving $0.4340 per share of common stock in cash.Virtual Therapeutics and Akili, Inc. announced that they have agreed to terms on a definitive merger agreement, aiming to establish a digital health company that creates engaging and immersive games to improve mental health. Under terms of the merger, Akili will now work as a wholly owned company of Virtual Therapeutics, Akili shareholders will receive $0.4340 per share of common stock in cash, representing a 4% premium to the closing stock price.1 “In today’s global mental health crisis, patients deserve access to clinically validated solutions that address their specific needs. We have been able to advance multiple solutions on our platform since founding Virtual Therapeutics, and we look forward to taking a significant step forward through this merger,” said Dan ...
- Source: drugdu
- 93
- June 5, 2024
At ASCO, AstraZeneca Adds Data Supporting Expanded Use of Its Drugs in Lung Cancer

AstraZeneca’s Tagrisso and Imfinzi helped patients live longer in separate pivotal clinical trials evaluating the drugs in two different types of lung cancer. The results will be presented Sunday during the annual meeting of the American Society of Clinical Oncology. By Frank VinluanAstraZeneca, which already has a strong presence in lung cancer, is poised to deepen its reach in the disease with clinical data that support expanding the use of two of its approved therapies in ways that clinicians say will change the standard of care for many patients. The data are set for presentation Sunday during the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. First up is the targeted therapy osimertinib, which is marketed under the brand name Tagrisso. The small molecule blocks mutated forms of the EGFR protein, which drives cancer growth. The drug is already approved for use as a first-line treatment ...
- Source: drugdu
- 90
- June 5, 2024
New UCL-developed immunotherapy shows promising results in treating bone cancer

Bone cancer affects more than 150,000 people in the UK and is often resistant to chemotherapy A new type of immunotherapy developed by researchers from University College London (UCL) has demonstrated promising preclinical results in treating bone cancer. Published in Science Translational Medicine, the OPS-gdT treatment platform outperformed conventional immunotherapy when controlling the growth of osteosarcoma, a form of bone cancer. Affecting more than 150,000 people in the UK, cancer that begins or spreads to the bones is hard to treat as it is frequently resistant to chemotherapy and is the leading cause of cancer-related death. Researchers used a small subset of immune cells known as gamma-delta T (gdT) cells, a type of immune cell that can be made from healthy donor immune cells, to provide an efficient and cost-effective solution for treating this condition. gdT cells work to kill antibody-labelled targets safely from person to person without risking graft-versus-host ...
- Source: drugdu
- 68
- June 5, 2024

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