Search Results for “EC” – Page 282 – 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
- 87
- 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
- 93
- 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
- 146
- 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
- 87
- 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
- 141
- 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
- 79
- 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
- 118
- March 9, 2024
Novo Nordisk Obesity Pill Flashes the Potential to Beat Wegovy in Weight Loss

Novo Nordisk reported its weight loss pill amycretin led to greater weight loss measured at 12 weeks compared to clinical trial results for its blockbuster obesity drug Wegovy. But these results are from a small Phase 1 study and more testing is needed. By FRANK VINLUAN An experimental Novo Nordisk obesity pill led to weight loss of 13.1% in a clinical trial, topping results posted in studies of the company’s approved injectable medication Wegovy. It’s early days and more testing is needed, but the preliminary data suggest that this pill has the potential to offer patients superior weight shedding in a more convenient oral formulation. Phase 1 data for the once-daily Novo Nordisk pill, amycretin, were presented Thursday during a company investor event. The study followed participants for 12 weeks. In that span, those who received a placebo lost 1.1% of their body weight. Wegovy, which is administered as a ...
- Source: drugdu
- 169
- March 9, 2024
Where there is a challenge, there is an opportunity

The challenges and opportunities surrounding Africa becoming a clinical trials global force were discussed on day one of CTS Europe. Révérien Uwacu speaking about the five African countries that have a WHO maturity level of three, signifying high capability of overseeing clinical trials. Image credit: Jenna Philpott/GlobalData. Over 18% of the global population lives in Africa, but less than 3% of clinical trials are conducted there. Is there an opportunity for clinical trials to be conducted in Africa? Experts at the ongoing Clinical Trial Supply (CTS) Europe meeting say the answer is yes, but not without its challenges. Leading the session, “Increasing diversity: supply chain considerations for clinical trials in Africa”, Révérien Uwacu, clinical trial supply management consultant for the pharma company UCB, emphasised the importance of diversity in clinical trials, for scientific, moral, and medical reasons. Révérien cited logistical challenges and regulatory complexities in trial supply management, as some ...
- Source: drugdu
- 124
- March 9, 2024
CPhI Japan 2024

Organiser: Informa Markets Time:17 – 19 April 2024 address：3-2-1 Aiakle Koto ku, Tokyo 135 0063 Japan Exhibition hall: Tokyo Big Sight International Exhibition Center Product range: Apis: vitamins, hormones, sulfonamides, antipyretic analgesics, tetracycline, amino acids and their derivatives, chloramphenicol, digestive system drugs, other anti-infective drugs, penicillins, aminoglycosides, lincomycin, cardiovascular system drugs, anti-parasitic diseases drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western drugs Ingredients Excipients and dosage forms: excipients, flow AIDS, enteric materials, antioxidants, sweeteners, penetration enhancers, preservatives, disintegrators, coating materials, surfactants, sunshades, flavors, filter AIDS, stabilizers, lubricants, plasticizers, solvents, flavor straighteners, coloring agents, clarifying agents, PH regulators, etc Natural extract: plant extract, animal extract, traditional Chinese medicine raw material, functional food raw material, health care raw material, nutrition and health raw material, supplement, dietary fiber, beauty cosmetics raw material Biological product reagents: antibody, nucleic acid/protein synthesis, carrier and construction, cell biology detection, animal/plant protein/antigen/polypeptide, nucleic acid ...
- Source: drugdu
- 165
- March 8, 2024

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