Search Results for “immune” – Page 3 – media

HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Treatment of Primary Immune Thrombocytopenia with Priority

Review Status Hong Kong, Shanghai & Florham Park, NJ — Thursday, January 11, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”). Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (“Syk”), being developed for the treatment of hematological malignancies and immune diseases. The NDA is supported by data from ESLIM-01, a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy. In August 2023, HUTCHMED announced that the trial had met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib ...
- Source: drugdu
- 105
- January 12, 2024
Bristol Myers Squibb to Pay Up to $8.4 Billion to Codevelop Antibody-Drug Conjugate With SystImmune

Pharmaceutical Executive Editorial Staff Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer. Bristol Myers Squibb (BMS) has reached an agreement with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) in a deal that could exceed $8 billion. As part of the agreement, BMS will pay $800 million upfront to SystImmune and up to $500 million in contingent near-term payments.1 Should certain developmental, regulatory, and sales performance milestones be achieved, SystImmune would be eligible for additional payments that would bring the total for the agreement to approximately $8.4 billion.1 “Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said ...
- Source: drugdu
- 131
- December 14, 2023
SystImmune and Bristol Myers Squibb Announce a Global Strategic Collaboration Agreement for the Development and Commercialization of BL-B01D1

December 11, 2023—SystImmune, a clinical-stage biopharmaceutical company, and Bristol Myers Squibb (NYSE: BMY) today announced an exclusive license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC). Under the terms of the agreement, the companies will jointly develop and commercialize BL-B01D1 in the United States. Through its affiliates, SystImmune will be solely responsible for development, commercialization, and manufacturing in Mainland China and will be responsible for manufacturing certain drug supplies for use outside of Mainland China. Bristol Myers Squibb will assume sole responsibility for development and commercialization in the rest of the world. BL-B01D1, a bispecific topoisomerase inhibitor-based ADC which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3), is currently being evaluated in a global multi-center Phase 1 study (BL-B01D1-LUNG101) for safety and efficacy in individuals with metastatic or unresectable non-small cell lung cancer (NSCLC). Data from earlier clinical ...
- Source: drugdu
- 125
- December 13, 2023
NeoImmuneTech bags orphan drug tag for IL-7 acute radiation syndrome treatment

The US Food and Drug Administration (FDA) awarded an orphan drug designation to NeoImmuneTech’s investigational drug for the treatment of acute radiation syndrome (ARS). The purpose of FDA orphan designation is to advance treatments for rare diseases like ARS. According to the Centers for Disease Control and Prevention (CDC), current treatments are geared towards preventing subsequent infections and treating infections and injuries. NT-17 (efineptakin alfa) (rhIL-7-hyFc) is a long-acting human IL-7 fusion protein designed to exceed the developmental and functional capabilities of endogenous IL-7 and comparatively amplify and enhance the T cell immune response. The drug, currently in preclinical development as a monotherapy, is expected to promote T-cell recovery by restoring lymphocyte levels and fortifying the body’s immune system after individuals are exposed to ionizing radiation. The clinical-stage biotechnology company is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the efficacy of NT-17 in treating ...
- Source: drugdu
- 95
- November 22, 2023
Q&A With Dr. Mike McCullar, CEO of RegCell

Mike Hollan McCullar discusses his new role as CEO of RegCell. Dr. Mike McCullar CEO RegCell Pharmaceutical Executive: How did you end up as CEO? Dr. Mike McCullar: Prior to joining RegCell as CEO and president, I was a toxicologist by training. I was fortunate to work in multiple operating roles over the years. I ended up working in Japan for a decade, and I was approached by a leading Japanese venture fund and asked if could help them start to migrate leading Japanese companies to the US. RegCell was one of those companies, and I felt it had the potential to have the best-in-class platform in terms of how we think about treating autoimmune disorders. It’s been an interesting journey so far. PE: What are the companies plans for the coming year? McCullar: What we’re focused on right now is launching a first in-human clinical trial. That takes quite ...
- Source: drugdu
- 116
- November 20, 2023
$13M NIH grant funds research to rejuvenate immune system in older adults

University of Arizona Health Sciences researchers received a $13.1 million grant from the National Institute on Aging to continue studies aimed at rejuvenating the immune system of older people in order to improve health throughout the lifespan. Older adults are disproportionally affected by infection, cancer and certain types of autoimmune disease. This is influenced by the fact that as a person ages, their body produces fewer T cells and gets less proficient at maintaining them. T cells are a type of white blood cell essential to the immune system and defense against infection. Janko Nikolich, MD, PhD, principal investigator, professor and head of the Department of Immunobiology at the University of Arizona College of Medicine – Tucson, said, “It is clear how much our immune system declines with age when you look at all the previous epidemics and pandemics that have hit us, including COVID-19. Older adults die at a ...
- Source: drugdu
- 109
- November 3, 2023
Study could pave the way to new treatments for people with compromised immune systems

New research led by Queen’s University Belfast has made a breakthrough in the field of microbiology, which could lead to the development of new treatments for people with compromised immune systems, such as those with cystic fibrosis. To conduct their study the researchers looked at the bacterium Achromobacter which can cause chronic lung infection and tissue damage in the airways. The study reveals how this bacterium overcomes the body’s immune defenses to multiply and continue to grow. The findings have been published in Cell Reports. Professor Miguel A. Valvano, Chair in Microbiology and Infectious Diseases at the Wellcome-Wolfson Institute for Experimental Medicine (WWIEM) at Queen’s University Belfast and lead researcher on the study, explains: “Achromobacter bacteria can cause chronic and potentially severe infections. However, until now, how this opportunistic bacterium interacts with the human immune system has been poorly understood. “These bacteria resist the action of multiple antibiotics; therefore, infection ...
- Source: drugdu
- 235
- October 3, 2023
Years after $2B buyout, Nestlé ditches Aimmune’s peanut allergy drug Palforzia

After lackluster sales dampened the initial enthusiasm that came with a $2.1 billion acquisition, Nestlé has finally found a new owner for its peanut allergy drug Palforzia. Nestlé has divested Palforzia to U.S.-based allergy specialist Stallergenes Greer for an undisclosed sum, the food giant said Tuesday. The transaction closed when the two companies signed the agreement. Nestlé will receive milestone payments and royalties from Stallergenes Greer. The deal comes later than expected. Back in November, Nestlé announced a strategic review of Palforzia, citing slower-than-expected uptake by patients and doctors. At that time, the review was expected to be done in the first half of 2023. Palforzia became the first drug approved by the FDA for peanut allergy in children in January 2020. Back then, Evaluate Pharma projected that the drug could reach $1.28 billion in sales by 2024. Seeing Palforzia’s value in its food allergy portfolio, Nestlé in August 2020 ...
- Source: drugdu
- 157
- September 7, 2023
Regeneron wins FDA approval for rare immune disease med Veopoz, expects high-dose Eylea decision in the coming weeks

Along with resolving site inspection issues that cost Regeneron a high-dose Eylea launch in June, the company has scored an FDA nod for Veopoz as the first treatment for the ultra-rare inherited immune condition Chaple disease. The disease, which is also known as CD55-deficient protein-losing enteropathy, has a global patient population of fewer than 100 people. In just the U.S., fewer than 10 patients have been diagnosed, Regeneron said in its Friday release. Chaple disease is caused by mutations of the complement regulator CD55 gene, which can lead the compliment system to attack the body’s own cells. Enter Veopoz, a fully human monoclonal antibody that targets a protein involved in complement system activation called compliment factor C5. It’s approved for patients 1 year of age and older and comes with a $34,615 price tag per single-use vial, a Regeneron spokesperson said in an emailed statement. The injection was tested in ...
- Source: drugdu
- 119
- August 22, 2023
Severe COVID-19 may cause long-term changes to innate immune system

Severe COVID-19 may cause long-lasting alterations to the innate immune system, the first line of defense against pathogens, according to a small study funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. These changes may help explain why the disease can damage so many different organs and why some people with long COVID have high levels of inflammation throughout the body. The findings were published online today in the journal Cell. Researchers led by Steven Z. Josefowicz, Ph.D., of Weill Cornell Medicine in New York City examined immune cells and molecules in blood samples from 38 people recovering from severe COVID-19 and other severe illnesses, as well as from 19 healthy people. Notably, the researchers established a new technique for collecting, concentrating and characterizing very rare blood-forming stem cells that circulate in the blood, eliminating the need to extract such cells from ...
- Source: drugdu
- 183
- August 21, 2023

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