PharmaFocus Today – Page 148 – media

Landmark Clinical Approval for YOLT-201 Obtained by the NMPA

YolTech Therapeutics, a biotech company developing in vivo gene editing therapies to treat rare genetic diseases, today announced the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has officially approved the YOLT-201 investigational new drug (IND) application for a Phase I study, marking that the drug candidate has officially entered the registration clinical development stage.. The first patient has been dosed with YOLT-201 in Investigator initiated trial(IIT) by the end of 2023, achieving promising preliminary efficacy and safety results. ATTR is a debilitating genetic disease, caused by misfolded transthyretin protein (TTR) forming amyloid fibrils and depositing in various organs and tissues in the body such as myocardium in the heart and peripheral nerves in the limbs. Depending on the mutation involved, hATTR can occur in people in their teens and 20s, though other forms are typically diagnosed in people over 50 years of age. YOLT-201 is ...
- Source: drugdu
- 89
- March 10, 2024
AACR 2024 | Ascentage Pharma to Present Three Preclinical Studies at 2024 American Association of Cancer Research Annual Meeting

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that the latest results from three preclinical studies of the company’s novel drug candidates olverembatinib, MDM2-p53 inhibitor alrizomadlin, FAK/ALK/ROS1 tyrosine kinase inhibitor APG-2449, and EED inhibitor APG-5918, have been selected for presentations at the 2024 American Association of Cancer Research Annual Meeting (AACR 2024). These abstracts are now available on the AACR’s official website. The AACR annual meeting is one of the world’s largest and longest-standing scientific gatherings in the field of cancer research. Covering some of the most cutting-edge advances in all the areas of oncology research and innovation, the annual event attracts tremendous interest from the global cancer research community. This year’s AACR annual meeting will be held from April 5-10 2024, in San Diego, California, USA. These three preclinical abstracts from Ascentage Pharma include: ...
- Source: drugdu
- 97
- March 10, 2024
Akeso Announced the First Patient Dosed in Phase III Trial of Cadonilimab(PD-1/CTLA-4) Combined with Chemotherapy versus Tislelizumab Combined with Chemotherapy in First-line Treatment of PD-L1 negative NSCLC

HONG KONG, March 6, 2024 /PRNewswire/ — Akeso Inc. (“Akeso”, 9926. HK) announced the enrollment of the first patient in the registrational Phase III clinical study comparing Cadonilimab (PD-1/CTLA-4 bispecific antibody) combined with chemotherapy versus Tislelizumab (PD-1 antibody) combined with chemotherapy in the first-line treatment for patients with PD-L1 negative (PD-L1 TPS＜1%) non-small cell lung cancer (NSCLC) (NCT05990127). Lung cancer is a prevalent malignancy with significant global incidence and mortality rates. Retrospective studies conducted both worldwide and in China have revealed that PD-L1 negative expression is observed in up to 48% of patients with driver gene-negative NSCLC. Immunotherapy combined with chemotherapy stands as the first-line standard treatment for these patients. However, current treatment approaches provide limited survival benefits for PD-L1 negative patients. Hence, there exists a pressing clinical imperative for novel treatment modalities to enhance patients’ clinical outcomes. Compared to PD-1/PD-L1 monoclonal antibodies, PD-1 monoclonal antibody plus CTLA-4 monoclonal antibody ...
- Source: drugdu
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- March 10, 2024
Chime Biologics Achieves ISO 27001 Certification to Strengthen Information Security in the CDMO Industry

After passing rigorous reviews on all the items of the control standards, Chime Biologics has obtained ISO 27001 certification, which is an internationally recognized standard for information security management. Dr. Jimmy Wei, President of Chime Biologics, said, “We are very proud to achieve ISO 27001 certification. As a global CDMO, Chime Biologics has always emphasized on protecting clients’ data and information and has comprehensive experience in data and information security. It is an important milestone that will further strengthen our global information security standards and our ability to be a trusted global partner.” Chime Biologics has three global ISO certifications, including ISO 14001 Environmental management systems certification, ISO 45001 Occupational health and safety management systems certification and ISO 27001 Information security management systems certification, demonstrating our full commitment in the environment protection, employees’ health and safety, as well as information security. About Chime Biologics Chime Biologics is a leading CDMO ...
- Source: drugdu
- 79
- March 10, 2024
Merck reports drop in net income for fiscal 2023

Despite declines in sales and EPS, Merck recorded a stable dividend of €2.20 per share for both 2023 and the preceding year. Merck’s EBITDA dropped by 15.6% from €6.504bn in 2022 to €5.489bn in 2023. Credit: Merck KGaA, Darmstadt, Germany and/or its affiliates. Merck KGaA (Merck) has reported a decline in financial performance for the fiscal year 2023, with net income attributable to shareholders falling by 15.1% to €2.82bn ($3.07bn), compared to €3.326bn in the previous year. Earnings per share (EPS) also saw a decrease of 15.2% to €6.49 from €7.65 in 2022. Group net sales experienced a downturn of 5.6% to €20.99bn from €22.23bn in 2022. The company has cited foreign exchange effects, particularly from the US dollar and the Chinese renminbi, as having a negative 4.1% impact on sales. Earnings before interest, taxes, depreciation and amortisation, a key financial indicator for business operations, also dropped by 15.6% from ...
- Source: drugdu
- 148
- March 9, 2024
The roadmap for generative AI in the pharma industry

AI remained one of the main talking points at CTS Europe, as the roadmap for generative AI was mapped out. In 2022, the launch of the generative Artificial Intelligence (AI) platform ChatGPT broke the record for the fastest-growing consumer application in history. Following the rapid adoption of AI technologies, the pharma sector is now exploring the capabilities and challenges of generative AI as it remains one of the key trends in the industry. However, despite the recent progress in the use of AI in real-world situations, we are still in the early stages of the AI roadmap, research director at GlobalData Josep Bori, at the recently concluded Clinical Trial Supply (CTS) Europe 2024 meeting. Generative AI is a technology capable of generating text, images or other data using generative models, often in response to prompts. Explaining how generative AI works, Bori said: “AI is trying to optimise the output to ...
- Source: drugdu
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- March 9, 2024
NHS to ensure people eligible for very high-risk breast screening are referred

Secondary breast cancer is an important risk factor after receiving radiotherapy for Hodgkin lymphoma NHS England has responded to the recent ministerial statement by newly establishing the Very High Risk (VHR) Pathway through the NHS Breast Screening Programme that invites eligible women for annual testing. The NHS is contacting 1,487 women who are at increased risk of breast cancer due to having radiotherapy involving their chest for Hodgkin lymphoma. Hodgkin lymphoma is an uncommon cancer that develops in the lymphatic system. An important risk factor after radiotherapy can include the development of secondary breast cancer, the most common cancer in the UK. Recently, the minister of state for health and secondary care, Andrew Stephenson, said in his statement that NHS England contacted a group of women who were at “very high risk of breast cancer who have been eligible for annual MRI checks, but who may not have been routinely ...
- Source: drugdu
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- March 9, 2024
US researchers develop algorithm test to identify aggressive ovarian cancers

Researchers from Johns Hopkins Kimmel Cancer Center and the Johns Hopkins University School of Medicine have developed an algorithm to identify high-risk precancerous lesions that lead to ovarian high-grade serous carcinoma (HGSC). Published in Clinical Cancer Research, researchers aimed to develop a tool that could detect and stratify serous tubal intraepithelial carcinomas (STICs) based on key genetic alterations and mutations. STICs are lesions that are presumed to be the main precursors of HGSC, the most common form of ovarian cancer in women. Using a technique called Repetitive Element AneupLoidy Sequencing System (RealSeqS), researchers sequenced 150 DNA samples and analysed the level of aneuploidy, missing or extra DNA chromosomes, in STIC versus HGSC and normal-appearing samples. Results showed that STIC samples had more non-random genetic alterations, including whole and partial deletions of chromosome 17 in the tumour suppressor p53 proteins, while normal-appearing samples had low levels of aneuploidy. The team suggests ...
- Source: drugdu
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- March 9, 2024
Simple Blood Test Could Detect Risk of Viral Infection-Induced Cardiac Arrest

Myocarditis, an inflammation of the heart often caused by the body’s immune response to a viral infection, can cause sudden cardiac death. Alarmingly, myocarditis accounts for up to 42% of sudden cardiac deaths in young adults, with viral infection being the primary cause. Traditionally, clinical understanding has focused on how inflammation affects heart rate or rhythm. Now, a new understanding from the latest research suggests completely different directions to diagnose and treat viral infections affecting the heart A new study led by scientists from the Fralin Biomedical Research Institute at Virginia Tech (Blacksburg, VA, USA) has discovered that the virus itself can create dangerous conditions in the heart even before inflammation begins. The study identified an acute phase where the virus first invades the heart, preceding the onset of inflammation due to the body’s immune response. This early infection stage sets the stage for arrhythmias before any tissue inflammation. The ...
- Source: drugdu
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- March 9, 2024
Novel Test Identifies Aggressive Ovarian Cancers Early

Ovarian high-grade serous carcinoma (HGSC) is the predominant form of ovarian cancer affecting women. Serous tubal intraepithelial carcinomas (STICs), which are precancerous lesions on the fallopian tubes, are considered the main precursors of HGSC. Women undergoing salpingectomy, the surgical removal of fallopian tubes, often do so without a detailed examination of these precancerous lesions. The challenge lies in the molecular diversity of STICs and the difficulty in detecting aggressive forms early, owing to their small size. In response to this urgent diagnostic need, researchers have developed an algorithm to identify STICs before they can progress to cancer. This pioneering algorithm, named “REAL-FAST” (RealSeqS-based algorithm for fallopian tube aneuploidy pattern in STIC), was developed by a team at Johns Hopkins Medicine (Baltimore, MD, USA). In a pilot study, REAL-FAST distinguished five unique types of precancerous lesions in fallopian tubes, with two identified as particularly aggressive and often linked to recurrent HGSC. ...
- Source: drugdu
- 121
- March 9, 2024

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