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Merck KGaA announces its largest investment in Asia

Merck KGaA Darmstadt Germany announced its largest investment in Asia through a ceremony of its € 300 million Bioprocessing Production Center in Daejeon, South Korea. The new facility will accelerate the biotech and pharmaceutical industry’s development by manufacturing vaccines, cell and gene therapies, and protein-based therapies. Once completed, the investment aims to create as many as 300 new jobs and continue to grow and support global demand for critical drugs and therapies. The ceremony witnessed the presence of the leadership team of Merck including Matthias Heinzel- CEO of the Life Science business, Karen Madden- Chief Technology Officer, Life Science business, Sebastián Arana- Head, Process Solutions, Life Science business, Ivan Donzelot- Head of Integrated Supply Chain Operations. They were joined by Cheong Inkyo, Trade Minister of Korea, Lee Jang Woo, Mayor of Daejeon, Ambassador Georg Schmidt along with other dignitaries and partners.
- Source: drugdu
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- May 31, 2024
New AI Transparency Rule Should Drive Higher Quality Tools & More AI Adoption

Micky Tripathi, head of The Office of the National Coordinator for Health Information Technology (ONC), thinks his office’s recent rule on AI transparency will do a good job of empowering both providers and tech developers. “I think it’s going to spur more adoption of AI-based tools in healthcare delivery, and hopefully, it’s going to establish a sort of mechanism for driving higher quality AI-based tools,” he stated during an interview this month at the Reuters Digital Health conference in San Diego. In December, the ONC finalized a new rule that instated transparency requirements for the use of AI in healthcare settings. It requires healthcare AI developers to provide more data about their products to customers, which could aid providers in determining AI tools’ risks and effectiveness. Under the new rule, AI vendors must share information about how their software works and how it was developed. That means disclosing information about ...
- Source: drugdu
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- May 30, 2024
Study reveals pivotal role of the circadian clock in enhancing checkpoint inhibitor cancer therapy

A multidisciplinary research team at the University of California, Irvine has revealed that the circadian clock – the biological pacemaker that governs daily rhythms in physiological processes, including immune functions – can be leveraged to enhance the efficacy of checkpoint inhibitor cancer therapy. Checkpoint inhibitors block different proteins from binding to tumor cells, allowing the immune system’s T cells to kill the tumor. The study, published online today in the journal Nature Immunology, provides deeper insights into the intricate relationship among the circadian clock, immune regulation and tumor development and found that a therapeutic approach optimizing time-of-day delivery based on an individual’s unique circadian patterns offers new avenues for prevention and treatment. Selma Masri, corresponding author, UC Irvine associate professor of biological chemistry, said, “Disruption of the internal biological pacemaker is an inherent aspect of modern society that may contribute to the rising incidence of many cancer types. We found ...
- Source: drugdu
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- May 30, 2024
Insmed’s Trial Results Pave Way for FDA Filing in a Lung Disease With No Approved Therapies

Brensocatib, a drug Insmed licensed from AstraZeneca, met the main goal of a Phase 3 test in non-cystic fibrosis bronchiectasis. Insmed plans to seek regulatory approvals in this indication while also continuing to develop the small molecule for other inflammatory disorders. By Frank VinluanAn Insmed drug developed for a serious chronic lung disorder with no FDA-approved therapies handily beat a placebo in a pivotal clinical trial, preliminary results that set the stage for a regulatory submission planned for later this year. It could be the first of several. The drug is also in development for other inflammatory conditions, giving the drug multiple opportunities to achieve its blockbuster potential. The first disease target of the Insmed drug is non-cystic fibrosis bronchiectasis (NCFB), a chronic lung disease characterized by excess production of sputum that’s persistently coughed up from the respiratory tract. Patients who have NCFB also experience frequent respiratory infections. There’s no ...
- Source: drugdu
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- May 30, 2024
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 ...
- Source: drugdu
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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
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- 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.
- Source: drugdu
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- May 30, 2024

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