Search Results for “immune” – Page 36 – media

Simple Blood Test Could Detect Risk of Viral Infection-Induced Cardiac Arrest

Myocarditis, an inflammation of the heart often caused by the body’s immune response to a viral infection, can cause sudden cardiac death. Alarmingly, myocarditis accounts for up to 42% of sudden cardiac deaths in young adults, with viral infection being the primary cause. Traditionally, clinical understanding has focused on how inflammation affects heart rate or rhythm. Now, a new understanding from the latest research suggests completely different directions to diagnose and treat viral infections affecting the heart A new study led by scientists from the Fralin Biomedical Research Institute at Virginia Tech (Blacksburg, VA, USA) has discovered that the virus itself can create dangerous conditions in the heart even before inflammation begins. The study identified an acute phase where the virus first invades the heart, preceding the onset of inflammation due to the body’s immune response. This early infection stage sets the stage for arrhythmias before any tissue inflammation. The ...
- Source: drugdu
- 90
- March 9, 2024
Gilead and Merus enter trispecific antibody discovery deal

The agreement outlines the potential for Merus to earn up to $1.5bn payments from Gilead. Merus will head the early-stage research works for two programmes, with the option to expand to a third asset. Credit: aslysun / Shutterstock.com. Gilead Sciences has entered a research partnership, option and licence agreement with Merus for the discovery of dual tumour-associated antigens targeting trispecific antibodies. The partnership will leverage Merus’ Triclonics technology and Gilead’s capabilities in the oncology field. The aim is to advance multiple preclinical research programmes that could potentially transform cancer treatment. Merus focuses on the development of full-length, multispecific antibodies named Biclonics and Triclonics, referred to collectively as Multiclonics. These antibodies are created by a common light chain technology. The Triclonics trispecific platform creates antibodies that can target three different antigens simultaneously. Merus will spearhead the early-stage research works for two programmes, with the option to expand to a third asset. ...
- Source: drugdu
- 108
- March 9, 2024
Gilead Sciences Signs Yet Another R&D Alliance for Multi-Target Cancer Therapies

Gilead Sciences’ partnership with Merus could yield novel antibody drugs capable of binding to three targets simultaneously. The alliance follows a collaboration that Gilead started last year with Tentarix Biotherapeutics, a startup also developing antibodies that bind to multiple targets. By FRANK VINLUAN Bispecific antibody drugs have shown that binding to two targets simultaneously can be a powerful and effective way to treat cancer. Binding to three targets could be even better, and Gilead Sciences is turning to biotech company Merus to find out. Under the collaboration agreement announced Wednesday, Gilead is paying Merus $56 million up front and making a $25 million equity investment in the biotech. Netherlands-based Merus focuses on developing antibody therapies that bind to two or three targets at the same time. This capability could block multiple receptors that drive tumor growth and survival. It could also coax a patient’s immune cells to kill tumors. So ...
- Source: drugdu
- 105
- March 8, 2024
BIO-THERA’s Class 1 New Drug BAT7205 (PD-L1/IL-15) for Injection Approved for Clinical Trials in Locally Advanced or Metastatic Solid Tumors

BIO-THERA Bio-Pharmaceutical Co., Ltd (Stock Code: 688177) has recently received a Notice of Approval of Drug Clinical Trial approved by the State Drug Administration for the Company’s investigational product BAT7205 for injection. BAT7205 is a PD-L1/IL-15 bifunctional antibody fusion protein developed by BIO-THERA and is intended to be developed for the treatment of locally advanced or metastatic solid tumors.IL-15 is a pleiotropic cytokine that is essential for the regulation of many immune functions, particularly the development, proliferation and activation of CD8+ memory T cells and NK cells, and promotes PD-1 inhibitor-naïve CD8 + activation and proliferation of tumor-infiltrating T cells, which is expected to significantly improve the clinical efficacy of PD-1/PD-L1 analogs. BAT7205 consists of recombinant humanized anti-PD-L1 antibody and IL-15/IL-15Rαsushi fusion protein, which can both block the PD-1/PD-L1 immunosuppressive pathway and activate the immune cells through IL-15, thus achieving the synergistic effect of deregulation of immunosuppression and activation of ...
- Source: drugdu
- 172
- March 8, 2024
FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs

Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
- Source: drugdu
- 134
- March 7, 2024
FDA Clears Quoin Pharmaceuticals to Employ Teens for Netherton Syndrome Clinical Trials

Don Tracy, Associate Editor Teens to be included in both placebo and open label studies for QRX003, a potential treatment for Netherton syndrome. Today, Quoin Pharmaceuticals announced that the FDA has given approval to include teenagers aged 14 years and older in two ongoing clinical trials for QRX003, a potential treatment for Netherton syndrome (NS). According to a press release, this marks the first time that teen patients with NS will have the opportunity to participate in clinical trials under an Investigational New Drug Application (IND). Additionally, the studies will accommodate teens currently on off-label systemic therapy, with the focus of generating comprehensive data for QRX003’s development.1 “We are very pleased to announce this exciting development, not just for Quoin’s clinical program, but for the Netherton community as a whole,” said Michael Myers, BSc, PhD, CEO, Quoin, in a press release. “We are frequently petitioned by parents and caregivers that ...
- Source: drugdu
- 113
- March 6, 2024
FDA director signals accelerated approval of gene therapy becoming normal! Multiple gene therapies are expected to be launched this year

“If we don’t move toward accelerated approval, many patients will not be able to receive treatment in a timely manner. For many initial approvals of gene therapies, accelerated approval will become the standard process.” Peter Marks said at a seminar held by the Reagan-Udall Foundation in Washington last week . There are currently more than 10,000 rare diseases, but companies often struggle to bring treatments for these diseases to market due to small patient populations and financial constraints. Accelerated approval is a tool that can advance the development of innovative treatments and ensure that companies do not abandon promising treatments. Peter Marks said: “There are many gene therapies for rare diseases that are almost successful. The key question now is, how do we push them to the finish line smoothly?” For gene therapy for rare diseases, a balance between supervision and science is needed. How to supervise gene therapy more ...
- Source: drugdu
- 131
- March 6, 2024
Henlius Adalimumab Biosimilar Received sNDA Acceptance Notification from the NMPA

Shanghai, China, 29th February 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis，pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA)，bringing new hope to pediatric patients and their families. As of now, HANDAYUAN has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. Autoimmune diseases are a group of diseases caused by the body’s immune system attacking its own organs or tissues[1]. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases[2]. Currently, autoimmune diseases are difficult to cure, and once it occurs, most patients need long-term to lifelong medication. Some autoimmune diseases are particularly dangerous and severely affect the quality of life of patients, posing a threat to their lives and ...
- Source: drugdu
- 77
- March 6, 2024
CDC’s Advisory Committee Recommends Another Round of Covid-19 Shots for Seniors

Mike Hollan The agency updated its recommendations after a vote by the ACIP advisory committee. The Covid-19 shot isn’t done yet. The CDC is recommending that people over the age of 65 should get another injection of the COVID-19 vaccine. The recommendation comes after the CDC’s Advisory Committee on Immunization Practices (ACIP) voted on the matter, CNN reports.1 The committee voted 11 yes, one no, and one member abstained. According to the new recommendation, anyone over the age of 65 should get the latest version of any of the available COVID vaccines if it has been at least four months since their previous shot. According to CNN, CDC epidemiologist Dr. Ruth Link-Gelles said during a meeting with ACIP advisors, “[The vaccine] doesn’t protect absolutely,” she said. “What the vaccines are doing now is providing an incremental benefit or an extra benefit beyond whatever benefit someone has remaining from their past ...
- Source: drugdu
- 233
- March 5, 2024
Biotheus’s PD-L1/VEGF dual antibody is planned to be included in breakthrough therapeutic category and has reached a licensing cooperation of over US$1 billion

Today (1st March), the official website of the Center for Drug Evaluation (CDE) of the NMPA announced that the PM8002 injection applied by Biotheus is planned to be included in the breakthrough therapy category, and the indication is the first-line treatment of inoperable locally advanced/recurrent metastatic triple-negative breast cancer with albumin-bound paclitaxel for combined injection. Public information shows that PM8002 is an anti-PD-L1/VEGF bispecific antibody independently developed by Biotheus. BioNTech has reached a cooperation agreement of more than US$1 billion with Biotheus to obtain the development, production and commercialization rights of this product worldwide (except Greater China). PM8002 is a bispecific antibody drug candidate consisting of a humanized anti-PD-L1 mono-antibody (VHH) fused to an anti-VEGF-A IgG1 antibody containing an Fc-silent mutation. This design can enrich PM8002 molecules into the tumor environment and reduce the systemic side effects caused by systemic VEGF blockade. According to an earlier press release fromBiotheus, PM8002 ...
- Source: drugdu
- 129
- March 5, 2024

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