PharmaFocus Today – Page 160 – media

Latest Research Results of Magnesium Isoglycyrrhizinate GM-DILI-002 Announced

Recently, the 33rd Annual Meeting of the Asia-Pacific Association for the Study of the Liver (APASL 2024) presented a study (GM-DILI-002) analyzing the efficacy of Chiatai Tianqing magnesium isoglycyrrhizinate (MgIG) in the treatment of liver injury associated with a novel antitumor drug based on real-world data from China, and the results of the study (No. 100906 and No. 100910) fill the evidence-based Gap. This real-world, non-interventional, multi-center, retrospective study was conducted in three main settings. The study was based on an e-diagnostic system that screened and analyzed data from a population of 1,710 patients who met international liver biochemical criteria related to DILI (drug-induced liver injury) during treatment with novel antineoplastic agents. In recent years, the emergence of new antitumor drugs, such as molecular targeting and immune checkpoint inhibitors, has led to a continuous improvement in the survival of tumor patients, but at the same time the problem of drug-related ...
- Source: drugdu
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- April 4, 2024
Researchers Present First Study Using Biomimetic AI Digital Twins

Mike Hollan The study used technology developed by a variety of companies, including RYLTI. AI digital twins are here. A group of researchers presented the first study to use digital twins created using AI. According to a press release,1 the group consisted of researchers from Genzeva, LumeGene, RYLTI, Brigham & Women’s Hospital of Harvard University, and QIAGEN Digital Insights worked together to bring the digital creations into a study on the molecular mechanisms of endometrial-related disorders. Dr. William G. Kearns, co-founder, CEO, and chief scientific officer at Genzeva and LumaGene, led the study. In a press release, he said, “This landmark study demonstrated a way to combine omics and a digital twin ecosystem to understand the molecular mechanism of disease better. By incorporating Genzeva’s multiomics platform, QIAGEN’s Digital Insight, and RYLTI’s pioneering biomimetic AI platform for genomic analyses we uncovered hidden dark data with insights that may never have been ...
- Source: drugdu
- 164
- April 3, 2024
Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12

Don Tracy, Associate Editor Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies. Gilead Sciences and Xilio Therapeutics announced that they have agreed to terms on a licensing agreement regarding XTX301, Xilio’s Phase I tumor-activated IL-12. According to Gilead, the partnership aims to expand the company’s focus in immuno-oncology, leveraging Xilio’s novel tumor-activation platform to improve its therapeutic nature and build a consistent pipeline of tumor-activated molecules. As per the deal, Xilio will receive an upfront payment of $43.5 million, with $30 million in cash and an equity investment of $13.5 million provided by Gilead in common stock. Overall, Xilio will have the opportunity to earn up to $604 million based on specified development, regulatory, and sales-based milestones.1 “Xilio’s novel tumor-activation platform naturally complements Gilead’s clinical development program in difficult-to-treat cancers and expands our focus in immuno-oncology,” said Bill Grossman, MD, PhD, SVP, ...
- Source: drugdu
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- April 3, 2024
Upgraded Syndromic Testing Analyzer Enables Remote Test Results Access

QIAGEN (Venlo, the Netherlands) has released the QIAstat-Dx Analyzer 2.0, including the Software 1.6 upgrade. This represents a significant advancement from the initial QIAstat-Dx Analyzer 1.0, offering enhanced capabilities for the accurate, rapid, and cost-effective identification of complex syndromes. The system, which is designed for laboratory settings, incorporates economical, disposable cartridges that integrate sample preparation with all necessary reagents on board. Leveraging multiplex real-time PCR technology, it can identify and distinguish between various pathogens, delivering results within approximately one hour. Additionally, the system enables the display of cycle threshold (Ct) values and amplification curves, providing deeper analytical insights beyond those achievable with endpoint PCR or alternative methodologies. A key feature of this upgraded system is the introduction of the QIAstat-Dx Operational Module PRO, which is equipped with a 64-bit processor and 4GB of RAM. This enables the Remote Results Application, a pioneering tool in syndromic testing that allows for the ...
- Source: drugdu
- 137
- April 3, 2024
Single Genetic Test to Accelerate Diagnoses for Rare Developmental Disorders

Alterations in human DNA range from minor single nucleotide variations to substantial alterations involving the deletion or duplication of extensive DNA segments, known as copy number variations (CNVs). While CNVs contribute significantly to human genetic diversity and are often harmless, they can also lead to various neurodevelopmental disorders like Angelman syndrome, DiGeorge syndrome, and Williams-Beuren syndrome. Children suspected of having genetic conditions due to these significant DNA deletions or duplications typically undergo a lengthy diagnostic process that begins with microarray testing and may advance to more comprehensive genome-wide sequencing tests, such as exome or genome sequencing. Detecting CNVs in sequencing data and interpreting them can be challenging for clinical teams, which is why microarrays are commonly employed. Scientists have now created a single approach to identify these structural alterations using data from genome-wide exome sequencing assays. The findings of the study by researchers from the Wellcome Sanger Institute (Cambridgeshire, UK) ...
- Source: drugdu
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- April 3, 2024
A step towards global harmonisation of GMP inspection protocols

In a letter dated March 21, the US FDA India office country director Sarah McMullen said that four states (Gujarat, Telangana, Goa and Karnataka) had been ‘sensitised to FDA’s inspection process and, as such, are eligible for inclusion as observers for relevant inspection in their respective states.’ The letter goes on to mention, ‘We would appreciate relevant opportunities being made available to state inspectors to attend as observers as practical.’ US FDA’s ‘Observed Inspection Program‘ involves interaction between the USFDA India office and State Drug Control Authorities, with the former inviting the latter as observers during inspections. As the letter indicates, ‘FDA has shared best practices and inspectional protocols in regulatory forums with several states.’ It is logical that the US FDA would now turn to replicate these efforts in other states, especially those with many FDA-registered facilities, like Maharashtra, for instance, and explore the possibility of adding to this ...
- Source: drugdu
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- April 3, 2024
GlobalData

In the dynamic landscape of the pharma industry, collaboration often serves as the key to innovation and expanding market presence. In recent years, the Asia-Pacific (APAC) market has emerged as a hub for pharmaceutical development and investment, attracting attention from both local and global players. While cooperation between APAC-based pharmaceutical companies and their global counterparts has been on the rise, active cooperation among pharma companies within the APAC region is gaining traction, observes GlobalData. According to GlobalData’s Pharmaceutical Intelligence Center, from 2019 to 2023, 673 deals (strategic alliances) occurred among companies that are purely based in APAC, with 360 deals* of them being for unique therapy areas. It is interesting to note that 44 per cent of these deals* are for oncology, followed by infectious diseases (20 per cent), central nervous system disorders (12 per cent), cardiovascular disorders (4 per cent), and ophthalmology (4 per cent). The infectious disease space ...
- Source: drugdu
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- April 3, 2024
WHO publishes new guidelines on hepatitis B

WHO has released new Guidelines on prevention, diagnosis and treatment of chronic hepatitis B (HBV) infection at the 2024 Asian Pacific Conference for the Study of Liver Disease (APASL) in Kyoto, Japan. These guidelines provide a substantial simplification and expansion of eligibility for treatment to overcome barriers in access to HBV testing and treatment. More than 250 million people live with chronic hepatitis B infection, leading to increasing deaths each year. Most of the global burden of chronic hepatitis B (CHB) is due to mother-to-child transmission at or shortly after birth. WHO’s Global health sector strategy sets actions and targets to eliminate viral hepatitis by 2030 by driving new infections and deaths down to half a million each globally – a reduction of 90% and 65%, respectively. Considerable progress has been made towards eliminating mother-to-child transmission of HBV through universal infant HBV immunization, including the timely hepatitis B birth dose. ...
- Source: drugdu
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- April 3, 2024
Promoting a risk-based approach for the regulatory oversight of vaccines used in pandemics

Global guidelines on regulatory preparedness for pandemic influenza vaccines have been revised to strengthen the regulating of vaccines risk-based approaches to vaccine regulation in the event of a pandemic. During the 2009 H1N1 influenza pandemic, the deployment of pandemic influenza vaccines in importing countries was delayed or disrupted due to the lack of regulatory preparedness. This resulted in WHO developing guidelines for non-vaccine producing countries on the appropriate regulatory approaches to the marketing authorization and lot release of pandemic influenza vaccines in public health emergency conditions. These guidelines were developed in the context of the Pandemic Influenza Preparedness (PIP) Framework’s Partnership Contribution High Level Implementation Plan, covering regulatory capacity-building and strengthening of pandemic preparedness and response. However, subsequent public health emergencies such as the Ebola epidemic and COVID-19 pandemic further exposed gaps in regulatory preparedness for other types of pandemic vaccines. The role of national regulatory authorities was not acknowledged ...
- Source: drugdu
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- April 3, 2024
Alebund’s Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SHANGHAI, March 29, 2024 /PRNewswire/ — Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AP303 for the treatment of autosomal dominant polycystic kidney disease (ADPKD). “We are very excited that AP303 has been granted Orphan Drug Designation by the FDA”, Dr. Gavin Xia, Co-founder, Chairman, and CEO of Alebund commented. “It is an important milestone for Alebund as well as our efforts to address the significant unmet medical needs with ADPKD. We look forward to advancing AP303 to improve future treatment options for patients in need.” AP303, a novel drug candidate developed in-house by Alebund, has demonstrated a meaningful improvement of renal survival in an ADPKD mice model. AP303 has completed its first-in-human study in healthy ...
- Source: drugdu
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- April 3, 2024

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