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Eli Lilly Drug Reduces Risk of Diabetes Onset, Building Case for Broader Use of the Therapy

In a Phase 3 study, Eli Lilly’s tirzepatide led to a 94% reduction in the risk that obese or overweight prediabetes patients progress to type 2 diabetes. Lilly was already planning to expand use of the blockbuster metabolic disorders drug to sleep apnea and heart failure. By Frank Vinluan The longest clinical trial to date for a blockbuster Eli Lilly metabolic disorder drug now has data showing the treatment delayed progression to type 2 diabetes in patients who are obese or overweight, results that continue to build the case of broader health benefits for the therapy. The preliminary results announced Tuesday come from a clinical trial designed to test once-weekly injections of tirzepatide in prediabetes participants. In addition to being overweight or obese, participants also had at least one weight-related complication, excluding diabetes. The main goal of the placebo-controlled study is assessing tirzepatide’s effect on weight. At the highest of three ...
- Source: drugdu
- 74
- August 22, 2024
J&Js Rybrevant plus Lazcluze combination gets FDA approval in NSCLC

Johnson & Johnson’s (J&J) Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) has secured US Food and Drug Administration (FDA) approval as a first-line treatment for patients with some types of non-small cell lung cancer (NSCLC). The indication covers patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. The approval is based on data from the Phase III MARIPOSA study (NCT04487080), which compared the Rybrevant/Lazcluze combination to AstraZeneca’s Tagrisso (osimertinib). Data showed that Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% compared to Tagrisso alone. Additionally, the median duration of response was nine months longer with the combination therapy compared to Tagrisso. The study met its primary endpoint of progression-free survival (PFS) and additional secondary endpoints, including participant race, type of EGFR mutation, and history of brain metastasis. These ...
- Source: drugdu
- 83
- August 22, 2024
Adcendo and Multitude ink ADC deal potentially worth $1bn

The antibody drug conjugate (ADC) dealmaking trend has seen yet another example as Adcendo has signed a licencing agreement potentially worth over $1bn with China-based Multitude for its tissue factor-targeting ADC candidate. The Danish company will acquire the global rights for the development and commercialisation rights for ADCE-T02, except in the Greater China region, including mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan. The companies were light on financial details noting that upfront and milestone payments will “total over $1bn”. The deal also has the option for “single digit to low double digit” tiered royalties. “We are highly impressed by the deep science behind Multitude Therapeutics’ linker/payload platforms and are delighted about our licensing agreement on ADCE-T02, which perfectly complements our existing unique first-in-class ADC pipeline and allows Adcendo to become a clinical-stage biotech company in Q4 2024,” said Adcendo CEO, Michael Pehl. “The highly ...
- Source: drugdu
- 76
- August 22, 2024
Nature publishes new research on genetic causes of colorectal cancer

Colorectal cancer (CRC) is the third most commonly diagnosed cancer globally, with more than 44,000 new cases of the disease diagnosed in the UK every year. Now a study led by the Institute of Cancer Research (ICR), the University of Oxford and the University of Manchester has revealed previously unknown genetic causes of (CRC). The new research, published in Nature, offers a novel view of the genetic landscape of CRC and treatment responses. Led by Genomics England and NHS England, researchers analysed 2,023 bowel cancers from the 100,000 Genomes Project to identify new gene faults that lead to CRC. The research uncovered new CRC cancer sub-groups with specific genetic characteristics that affect how cancer behaves and responds to treatment. Commenting on the findings, co-lead researcher and ICR’s professor of cancer genomics, Richard Houlston, said: “This research is a great insight into the biology of CRC, uncovering the clues as to ...
- Source: drugdu
- 52
- August 22, 2024
Oncimmune announces new contract with global pharma company

Oncimmune, an autoantibody profiling company providing research services to the pharmaceutical and biotechnology industry to enable the delivery of precision medicine, has announced a new contract with a global pharma company. Following a successful pilot carried out for a major pharmaceutical company, Oncimmune has entered into an agreement for a major new project with the same customer, with a contract value of at least US$1.5m. During the pilot project, Oncimmune was able to demonstrate that it can reliably profile Immunoglobulin E (‘IgE’) autoantibodies in blood serum using its high-throughput bead-based platform. The new project is expected to be delivered over the next six months, with the majority of the revenue therefore falling into FY2025. Martin Gouldstone, CEO of Oncimmune said: “I am delighted that our scientific team has demonstrated our ability to measure IgE, which is much harder to detect in blood serum than other immunoglobulins, using our high-throughput platform.” ...
- Source: drugdu
- 67
- August 22, 2024
First-Of-Its-Kind AI-Enabled Smart Microscopy Platform to Accelerate Traditional Pathology Workflows

Pathology and tissue analysis are areas poised for transformative advancements. Drug developers and clinicians currently depend on long-established methods for crucial tasks such as diagnosing diseases, quantifying biomarkers, and predicting therapeutic responses. While there have been attempts to innovate by digitizing specimens and adding multiple markers to a single slide, there are still limitations, including the analysis of less than 1% of tissue samples and the inability to depict complex tissue architectures and cellular interactions that are only visible in three dimensions. 3D imaging technology captures significantly more data than traditional slide-based methods by digitizing whole biopsy specimens rather than just thin slices.Artificial intelligence (AI) and machine learning algorithms play a crucial role in quantifying relevant biomarkers and identifying areas for more detailed pathologist examination. Now, a pioneering 3D spatial biology platform can digitize entire tissue specimens quickly and non-destructively while providing AI-enabled quantitative analysis. This technology enhances the precision ...
- Source: drugdu
- 90
- August 21, 2024
Novel Nanoparticles Found in Blood Pave Way for Less Invasive Cancer Diagnosis

Extracellular vesicles (EVs) and exosomes, tiny nanoparticles about 1,000 times smaller than a human hair, are secreted by all cells into biofluids like blood and urine. These particles are known to transport genetic material safely through the body. Researchers have now discovered a new class of RNAs within EVs that could transform the diagnosis and treatment of cancer and other diseases. This team found that these RNAs change in the presence of cancer, indicating their potential as biomarkers for diseases like prostate cancer or as therapeutic targets. The research group at the Icahn School of Medicine at Mount Sinai (New York, NY, USA) has dubbed these RNAs “EV-UGRs” (Extracellular Vesicles-Associated Unannotated Genomic Regions), following their identification in the blood and urine of patients with prostate cancer. UGRs, often described as the genome’s “dark matter,” play a key role in gene regulation and protein synthesis. The team previously discovered that EVs ...
- Source: drugdu
- 104
- August 21, 2024
FDA Approves Incyte and Syndax Pharmaceuticals’ Niktimvo for Treating Chronic Graft-Versus-Host Disease

By Don Tracy, Associate Editor Approval of Niktimvo was based on positive data from the AGAVE-201 study, which demonstrated a 75% response rate in patients with chronic graft-versus-host disease.The FDA has approved Incyte Sundax Pharmaceuticals’ Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for treating chronic graft-versus-host disease (GVHD) in patients who have not responded to at least two previous lines of systemic therapy. According to both companies, Niktimvo is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD. The approval was based on promising results from the AGAVE-201 study.1 “With the approval of Niktimvo, patients with chronic GVHD whose disease has progressed after prior therapies, now have a new treatment option with a novel mechanism of action to help address the serious and devastating complications associated with this disease,” said Hervé Hoppenot, CEO, Incyte, in a press release. “Niktimvo is Incyte’s second approved treatment for ...
- Source: drugdu
- 84
- August 21, 2024
Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut

Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. By Frank VinluanWhen the FDA approves a drug, passing that regulatory bar of safety and efficacy puts it on the path toward likely reimbursement by government and commercial payers. The same has not been true for digital therapeutics. A proposal from the Centers for Medicare and Medicaid Services signals a change in federal thinking about such technologies, which could pave the way for broader coverage of novel digital medicines. For the first time, CMS’s proposed physician fee schedule, a comprehensive annual listing of the fees that Medicare uses to pay doctors, now includes digital therapeutics. The proposal does not cover all digital therapeutics under multiple benefit categories, as the Digital Therapeutics Alliance (DTA) had asked nearly a year ago. ...
- Source: drugdu
- 70
- August 21, 2024
South African president calls on WHO for better mpox response

Amidst the global health emergency declared for mpox, the South African president has called for a greater emphasis on an equitable distribution of healthcare interventions. The World Health Organization (WHO), “must be different and correct the unfair treatment from the previous one [public health emergency] declared in 2022, where vaccines and therapeutics were developed and made available primarily to Western countries, with little support extended to Africa,” said Cyril Ramaphosa, the president of South Africa in a 17 August statement on the recent mpox outbreak in Africa. Ramaphosa called on the WHO to collaborate more closely with the Africa Centers for Disease Control and Prevention (Africa CDC) to allow wider access to vaccines, while countries in the African Union (AU) to increase domestic resource allocation. The AU is a continental union consisting of 55 African member states. Thus far, the AU has granted $10.4m in emergency funds to support Africa ...
- Source: drugdu
- 79
- August 21, 2024

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