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FDA Grants Fast Track Designation to AV-001 for Moderate-to-Severe Acute Respiratory Distress Syndrome

Don Tracy, Associate Editor Fast track designation for AV-001 comes amid promising results from a Phase I trial, which supported once-daily dosing and effective Tie2 activation. Vasomune Therapeutics announced that the FDA has granted Fast Track designation to AV-001, an investigational drug in development to prevent or treat moderate-to-severe acute respiratory distress syndrome (ARDS) in patients with respiratory infections. According to the company, Phase I data demonstrated the safety and pharmacokinetic profile of AV-001, backing once-daily dosing. Additionally, the treatment showed support for strong Tie2 activation. AV-001 is currently recruiting patients for a Phase IIa trial as an ARDS treatment in pneumonia.1 “Vasomune is focused on the persisting unmet needs of people grappling with ARDS and other diseases driven by vascular endothelial instability,” said Brian Jahns, PharmD, president, chief operating officer, Vasomune Therapeutics, in a press release. “Vasomune is indebted to the United States Department of Defense Congressionally Directed Medical ...
- Source: drugdu
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- May 30, 2024
Cure Genetics Announced Promising Safety and Efficacy Data of CAR-NKT Product CGC729 for RCC at ASGCT 2024

SUZHOU, China, May 23, 2024 /PRNewswire/ — On May 10, 2024, Cure Genetics announced the safety and efficacy data of their CAR-NKT product, CGC729, for patients with relapsed and refractory metastatic renal cell carcinoma (R/R mRCC) in an oral presentation at the 27th Annual Meeting of the American Society for Gene & Cell Therapy (ASGCT) in Baltimore. This marked the first-in-human trial using CAR-NKT therapy for R/R mRCC, demonstrating a good safety profile and encouraging anti-tumor activity. This phase I dose-escalation clinical trial was conducted at Fudan University Shanghai Cancer Center using a single-arm, 3+3 design to evaluate the safety and efficacy of CGC729 at three dose levels (DL1: 5 x 106/m2; DL2: 1.5 x 107/m2; DL3: 4.5 x 107/m2) in the treatment of R/R mRCC patients who had at least two lines of prior therapy. As of April 2024, five patients were enrolled and received a single infusion of ...
- Source: drugdu
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- May 30, 2024
Positive Results Achieved in Phase III Study of Benmosubimab in Combination with Anlotinib for First-Line Treatment of Advanced Renal Cell Carcinoma

Recently, Chiatai Tianqing Pharmaceutical Group’s randomized, open, positive drug-parallel controlled, multicenter Phase III clinical study of Benmelstobart (TQB2450), a Class 1 innovative biologic drug, in combination with Anlotinib, a Class 1 innovative drug, for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma (RCC) has completed the protocol-prescribed interim analysis of the ETER100 study. ETER100 study) has completed the protocol-prescribed interim analysis, and the Independent Data Monitoring Committee (IDMC) has determined that the primary study endpoint of progression-free survival (PFS, based on independent imaging assessment) has met the protocol-prescribed superiority cut-off, and that the secondary endpoint of overall survival (OS) has shown a trend toward benefit. The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration of China regarding the marketing application for this indication, and has obtained the CDE’s consent to submit a marketing application for the addition of this new ...
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- May 30, 2024
Emcure and Gennova to resume mRNA collaboration with HDT

Emcure Pharmaceuticals and its biotech subsidiary, Gennova Biopharmaceuticals have amicably resolved all legal disputes with HDT Bio Corporation. The litigation between them, including before US courts and the arbitral tribunal in London, has been settled and dismissed. Gennova and HDT, who previously collaborated on the successful development of Gennova’s mRNA Covid-19 vaccines, will once again collaborate on the development and commercialisation of mRNA vaccines. The parties have entered into a long-term agreement to develop mRNA vaccines against a broad range of infectious diseases, in India and several other countries. As part of their agreement, HDT has granted a license to Gennova to use HDT’s patented mRNA vaccine technology in multiple fields. https://www.business-standard.com/companies/news/emcure-gennova-settle-legal-dispute-with-us-based-hdt-bio-sign-agreement-124052300762_1.html
- Source: drugdu
- 95
- May 30, 2024
Gerresheimer to acquire Blitz LuxCo Sarl, for EUR 800 million

Gerresheimer Glas GmbH, an indirect subsidiary of Gerresheimer AG, has signed a purchase agreement with funds advised by Triton for the acquisition of Blitz LuxCo Sarl, the holding company of the Bormioli Pharma Group (Bormioli Pharma). The purchase price is based on a determined enterprise value of around EUR 800 million, which corresponds to an adj. EBITDA multiple of around 10 Bormioli Pharma, has 9 production sites in Europe. The Group generates revenues of around EUR 370 million and an adj. EBITDA margin of around 21 per cent. Bormioli Pharma has a complementary portfolio of pharmaceutical primary packaging made of glass and plastic, as well as closure solutions, accessories, and dispensing systems. With this acquisition, Gerresheimer strengthens its European footprint with additional production sites, especially in Southern Europe, and underpins its market position as a leading full-service provider and global partner for the pharmaceutical and biotech industries. The acquisition is ...
- Source: drugdu
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- May 30, 2024
Asia Health 2024

Organiser：Informa Markets Time：10- 12 July 2024 address：60 New Ratchadapisek Road Klongtoey Bangkok 10110 Thailand Exhibition hall：Queen Sirikit National Convention Center Product range: Medical equipment: laboratory equipment and configuration, emergency and transportation facilities, surgical equipment, nursing and monitoring equipment, etc Medical technology: Plastic surgery and rehabilitation technology, medical building facilities and technology, medical information and communication technology, etc Medicine: all kinds of finished drugs, drugs, medical accessories, etc Hospital consumables: disposable medical supplies, medical disinfection supplies, etc Medical items: medical clothing and washing technology, nutrition catering equipment, medical furniture, etc About Asia Health： Bangkok Medical Device Exhibition (Asia Health) is the most authoritative medical device exhibition in Thailand. The radiation market mainly includes India, Malaysia, Indonesia, Vietnam, the Philippines and other Southeast Asian countries. Asia Health is a continuing success for exhibitors and visitors from all over the world.
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- May 30, 2024
Novel Technique Detects Novel Biomarkers for Kidney Diseases with Nephritic Syndrome

Nephrotic syndrome is associated with several kidney diseases such as minimal change disease (MCD), primary focal segmental glomerulosclerosis (FSGS), and membranous nephropathy (MN), and is characterized by high levels of protein in the urine. This condition primarily stems from damage to podocytes, the cells that filter blood in the kidneys, which results in protein leakage into the urine. Often, children diagnosed with MCD or FSGS are categorized under idiopathic nephrotic syndrome (INS), indicating an unknown cause. This is typically because children with elevated urinary protein levels seldom undergo kidney biopsies, which are the standard method for determining the underlying cause. Traditionally, the diagnosis of these conditions has been complicated due to their similar histological features and a general reluctance to perform invasive kidney biopsies, especially in children. Although anti-nephrin autoantibodies have been detected in some patients with MCD and FSGS, their exact role in the progression of these diseases remains ...
- Source: drugdu
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- May 29, 2024
New ADLM Guidance Provides Expert Recommendations on Clinical Testing For Respiratory Viral Infections

Respiratory tract infections, predominantly caused by viral pathogens, are a common reason for healthcare visits. Accurate and swift diagnosis of these infections is essential for optimal patient management. In light of the COVID-19 pandemic, there have been significant advancements in laboratory medicine, enhancing the testing capabilities for respiratory viruses. These advancements include the use of diverse sample types and the introduction of various new testing methods. However, these developments have also created a need for greater educational efforts on how best to utilize these novel testing options. Addressing this need, a new guidance document has been released, offering expert advice on essential aspects of clinical testing for respiratory viral infections, aiming to maximize the benefits of recent technological advances in this rapidly evolving field. This guidance has been formed by a multidisciplinary team of clinical microbiologists and infectious disease clinicians convened by the Association for Diagnostics & Laboratory Medicine (ADLM, ...
- Source: drugdu
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- May 29, 2024
With M&A Deal, Click Therapeutics’ Digital Prospects in Metabolic Disease Get Better

Click Therapeutics is acquiring the assets of Better Therapeutics two months after that digital therapeutics developer announced it would lay off all employees and shut down. Better’s main asset is AspyreRx, an FDA-authorized mobile app for type 2 diabetes. By Frank VinluanDigital therapeutics developer Click Therapeutics is building up its prospects in cardiometabolic disorders by acquiring the assets of Better Therapeutics, a company whose technology platform yielded one FDA-authorized product and could serve as a springboard for a range of drug and digital treatment pairings. Better’s FDA-authorized prescription digital therapeutic, named AspyreRx, is a type 2 diabetes mobile app that helps patients modify behaviors in order to change the course of their disease. Artificial intelligence enables the software to personalize treatment plans to each patient. AspyreRx secured FDA authorization last summer, but Better struggled to commercialize the product on its own. Payer coverage decisions on the app were pending as ...
- Source: drugdu
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- May 29, 2024
Express Scripts Announces New Independent Pharmacy Focused Strategy

Mike Hollan The company is collaborating with CPESN USA to bring more services to customers at independent pharmacies across the country. The pharmacy landscape continues to evolve. Express Scripts announced that it is collaborating with CPESN USA in order to provide easier access to a wider range of services at independent pharmacies across the United States.1 The collaboration is the result of guidance that the Independent Pharmacy Advisory Committee provided to Express Scripts. A total of 38 pharmacists from across the United States make up the committee. Express Scripts is the pharmacy benefits service business of Evernorth, which is part of The Cigna Group. Adam Kautzner, Pharm. D., is president of Evernorth Care Management and Express Scripts. In a press release, he said, “Local pharmacies are the doorway to essential health care for many people, and independent pharmacies are critical to closing gaps in care for many communities. This collaboration ...
- Source: drugdu
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- May 29, 2024

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