Search Results for “Clinical Trial” – Page 49 – media

Henlius to Release Latest Results of HANSIZHUANG and HANQUYOU at ESMO Congress 2024

2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain. During the conference, Henlius will release multiple results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU. The results to be displayed include the smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study, a pivotal phase 3 clinical study of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) led by Professor Ying Cheng from Jilin Cancer Hospital, and the exploratory biomarker analysis of ASTRUM-004 study, a pivotal phase 3 clinical study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (sqNSCLC) led by Professor Caicun Zhou from Shanghai East Hospital, School of Medicine, Tongji University. HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody（mAb）injection independently developed by Henlius, ...
- Source: drugdu
- 89
- August 12, 2024
Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology business. By Frank VinluanA Servier Pharmaceuticals drug designed to penetrate the brain to hit its targets is now FDA approved for treating two rare types of brain cancer. The FDA approval announced Tuesday covers the treatment of adults and adolescents 12 and older who have Grade 2 astrocytoma or oligodendroglioma. The drug, vorasidenib, may be prescribed after surgery, as long as the cancers have mutations to the IDH1 or IDH2 enzymes the once-daily pill is designed to inhibit. The FDA said this regulatory decision marks the agency’s first for a systemic therapy for these cancers driven by either the IDH1 or IDH2 mutations. France-based Servier, which has its U.S. headquarters in Boston, will commercialize its ...
- Source: drugdu
- 81
- August 10, 2024
Chinese CAR-T Pioneer Legend Biotech in Profile

Chinese player Legend Biotech reached a new turning point last month when its Johnson & Johnson-partnered Carvykti became the first BCMA-targeted CAR-T cell therapy to be approved by the FDA for second-line treatment of multiple myeloma. From its original roots in China to its first FDA approval in 2022, the company has remained uniquely focused on CAR-T cells targeting the BCMA protein. Humble Beginnings and a Breakthrough Approval Back in 2014, a team of Chinese scientists began investigating cell therapies for cancer under the banner of the “Legend Project,” operating in what the company calls “a room the size of a freight elevator.” After making the decision to focus its research solely on chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein in 2015, Legend began conducting its first clinical trials in 2016. The pioneering biotech landed its first major vote of confidence from the global life sciences community in 2017, ...
- Source: drugdu
- 69
- August 9, 2024
Janssen’s psoriasis drug shows promise for childhood diabetes

A new study led by researchers from Cardiff University, King’s College London (KCL), Swansea University and the University of Calgary has revealed that Janssen’s psoriasis drug, Stelara (ustekinumab), shows promise in treating childhood diabetes. Published in Nature Medicine and funded by a Medical Research Council and National Institute for Health and Care Research partnership, the study found that Stelara was more effective in treating the early stages of type 1 diabetes (T1D) in children and adolescents. Accounting for approximately 10% of diabetes cases in the UK, T1D occurs when the pancreas does not produce insulin or makes very little insulin. Since 2009, the immunotherapy Stelara has been used to treat psoriasis, a skin condition characterised by flaky patches of skin that affects around 60 million people globally, as well as other immune conditions, including psoriatic arthritis, severe Crohn’s disease and severe ulcerative colitis. In the study, researchers tested Stelara in ...
- Source: drugdu
- 64
- August 9, 2024
Kerendia Demonstrates Significant Efficacy Treating Heart Failure with Left Ventricular Ejection Fraction of 40% or More

By Don Tracy, Associate Editor The FINEARTS-HF study, which compared Kerendia to a placebo when added to standard therapy, met its primary endpoint by reducing cardiovascular death and total heart failure events. Results from the Phase III FINEARTS-HF study found that Bayer’s Kerendia (finerenone) demonstrated significant efficacy in treating heart failure patients with a left ventricular ejection fraction (LVEF) of 40% or greater. According to the company, the study met its primary endpoint by significantly reducing the composite measure of cardiovascular death and total heart failure events, including both hospitalizations and urgent visits for heart failure.1 “We are very excited by the positive results from the FINEARTS-HF study,” said Christian Rommel, PhD, head of Research and Development, Bayer’s Pharmaceuticals Division. “With limited options currently available for patients with this common form of heart failure with a mildly reduced or preserved ejection fraction, this news is hugely important for patients and ...
- Source: drugdu
- 56
- August 8, 2024
Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology business. By Frank Vinluan A Servier Pharmaceuticals drug designed to penetrate the brain to hit its targets is now FDA approved for treating two rare types of brain cancer. The FDA approval announced Tuesday covers the treatment of adults and adolescents 12 and older who have Grade 2 astrocytoma or oligodendroglioma. The drug, vorasidenib, may be prescribed after surgery, as long as the cancers have mutations to the IDH1 or IDH2 enzymes the once-daily pill is designed to inhibit. The FDA said this regulatory decision marks the agency’s first for a systemic therapy for these cancers driven by either the IDH1 or IDH2 mutations. France-based Servier, which has its U.S. headquarters in Boston, will commercialize ...
- Source: drugdu
- 69
- August 8, 2024
FDA Approves Expanded Indication for Octapharma’s Fibryga for Patients Experiencing Bleeding Due to Acquired Fibrinogen Deficiency

By Don Tracy, Associate Editor Expanded indication makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication.The FDA has approved an expanded indication for Octapharma’s Fibryga, a lyophilized human fibrinogen concentrate now indicated for patients experiencing bleeding due to acquired fibrinogen deficiency (AFD). According to the company, this approval marks a significant advancement over cryoprecipitate, the current standard of care, by providing a faster and more precise treatment option for severe bleeding episodes. Additionally, the regulatory action makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication.1 “In the surgical theater, time matters. And confidence matters. This expanded FDA approval of fibryga represents a major step forward in our commitment to redefining the standard of care for patients experiencing major bleeding. It provides an important option for providers who must act urgently,” said Flemming Nielsen, president, Octapharma USA, ...
- Source: drugdu
- 80
- August 7, 2024
Bayer Looks to Expand Kerendia’s Label to Heart Failure After Phase 3 Win

Bayer reported a Phase 3 test of Kerendia in heart failure led to statistically significant reductions in cardiovascular death and hospitalizations. Detailed results will be presented during the European Society of Cardiology annual meeting in September. By Frank Vinluan Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure. In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure. Kerendia is a small ...
- Source: drugdu
- 64
- August 7, 2024
Jade Bio’s Launch, Brenig’s Debut, Confo’s Cash & More

Recent financing news includes several companies raising money to advance their research to the clinic. Here’s a look back at funding rounds from companies such as Outpace Bio, GRO Biosciences, and Confo Therapeutics. By Frank VinluanOne challenge for developing drugs for autoimmune diseases is that biologic therapies can spark an immune response against them. Immunology and inflammation research is coming up with new approaches to reduce the risk of such responses. That science is progressing in the hands of new companies raising fresh rounds of capital. Inflammation and immunology figures prominently in recent funding news, which includes several companies approaching the clinic with novel biologic drugs. Here’s a recap of recent biotech financings, grouped according to therapeutic area: Immunology & Inflammation —Abiologics unveiled an artificial intelligence-driven platform technology for designing novel biologic drugs based on non-standard amino acids. The startup, which has been incubating within Flagship Pioneering for the past ...
- Source: drugdu
- 82
- August 6, 2024
Researchers reveal CAR-enhancer therapy could help overcome cancer relapse

Cancer is estimated to affect more than three million people living in the UK, according to Macmillan Cancer Support Researchers from the Dana-Farber Cancer Institute have revealed in a study that CAR-enhancer (CAR-E) therapy could help patients overcome cancer relapse. In the findings published in Nature Biotechnology, researchers report on a technique to prevent relapse and researchers hope to launch the first trial in the near future. It is estimated that there are more than three million people living in the UK with cancer, according to Macmillan Cancer Support, with breast cancer being the most prevalent, accounting for more than 55,000 new cases every year. A common challenge faced when using CAR T-cell therapies is that many patients, including those whose cancer has gone into full remission, eventually relapse. To eliminate this problem, the new techniques create what researchers consider a CAR-E therapeutic platform, which causes CAR T cells to ...
- Source: drugdu
- 101
- August 6, 2024

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