Search Results for “Clinical Trial” – Page 2 – media

Hengrui Pharmaceuticals’ Innovative Anti-inflammatory Drug SHR-1819 for the Treatment of Prurigo nodularis Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals’ subsidiary, Guangdong Hengrui Pharmaceuticals Co., Ltd. received a Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, agreeing to conduct a clinical trial of SHR-1819 Injection for patients with Prutigo nodularis (PN). PN is a chronic, inflammatory skin disease clinically characterized by episodes of intense itching and multiple nodular lesions. The main clinical symptom is intense, recurrent itching accompanied by uncontrollable scratching, which leads to hyperkeratosis of the skin to the point of forming dome-shaped nodules.1 PN leads to the development of psychological disorders in patients who face a significant reduction in quality of life, reduced sleep quality, and anxiety and depression. According to Frost & Sullivan, the number of PN patients in China will be approximately 2 million in 2022 and is expected to reach 2.1 million in 2030. To date, there is no standard diagnosis and treatment program for PN, ...
- Source: drugdu
- 54
- August 12, 2024
Luye Pharma’s Dual TAAR1/5-HT2CR Agonist LY03020 Approved for Clinical Trials in China

Luye Pharma Group today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for LY03020 filed under the Class 1 pathway for investigational drugs. LY03020, a dual TAAR1/5-HT2CR agonist, is intended to treat schizophrenia and Alzheimer’s disease psychosis (ADP). Developed on Luye Pharma’s New Chemical Entity/New Therapeutic Entity (NCE/NTE) platform, LY03020 is a next-generation antipsychotic and the first agonist against both the trace amine-associated receptor 1 (TAAR1) and the 5-HT2C receptor (5-HT2CR) in the world. “Unlike the existing antipsychotics that typically antagonize D2 and 5-HT2A receptors on the postsynaptic membrane, the next-generation antipsychotics agonize those receptors on the presynaptic membrane. Compared with the existing antipsychotics, LY03020 targets both TAAR1 and 5-HT2CR, and thus is able to reduce adverse reactions such as extrapyramidal symptoms (EPS) and metabolic syndromes while significantly improving the negative symptoms and cognitive impairments ...
- Source: drugdu
- 67
- August 8, 2024
Vivacelle Bio Launches Phase III Clinical Trial for VBI-S to Treat Hypovolemic Septic Shock

By Don Tracy, Associate Editor The trial is expected to include 40 patients across the United States who haven’t responded adequately to standard hypovolemic septic shock treatments and are on vasopressors. Vivacelle Bio has launched a Phase III clinical trial for its leading therapeutic candidate, VBI-S, designed to treat hypovolemic septic shock. According to the company, the trial will be conducted across seven major septic shock treatment centers in the United States, which include some of the biggest septic shock treatment centers in the country. Investigators seek to compare VBI-S and standard of care (SOC) to SOC alone in a 1:1 ratio. “Initiation of our Phase III trial is a significant achievement for our team following years of dedicated work developing our phospholipid nanoparticle technology platform,” said Harven DeShield, PhD, JD, MSc, CEO, Vivacelle, in a press release. “Based on our excellent Phase II results, and the positive interaction with ...
- Source: drugdu
- 90
- July 25, 2024
Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection by SINOPHARM Lanzhou Institute of Biological Products Receives Clinical Trial Approval

On July 12, Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, a Class I new drug independently developed by SINOPHARM Lanzhou Institute of Biological Products, was granted a clinical trial approval notice by the State Drug Administration. Tetanus is a persistent tonic contraction and paroxysmal spasm of skeletal muscles throughout the body caused by the invasion of Clostridium tetani through a break in the skin or mucous membrane. Globally, the morbidity and mortality rate of tetanus is 30% to 50% after onset of the disease, even with aggressive treatment; in the absence of medical intervention, the mortality rate approaches 100%. According to the World Health Organization, tetanus currently kills about 1 million people worldwide each year. The term “tetanus shot” is short for tetanus passive immunization agent, which is usually isolated from healthy human or horse blood that has been vaccinated against tetanus. Tetanus injections are often needed in cases of ...
- Source: drugdu
- 87
- July 25, 2024
Hengrui Pharmaceuticals’ Innovative Drug Dalsili, HRS-1358 Combination for Breast Cancer Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals and its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, approving the company’s novel and highly selective CDK4/6 inhibitor, dalsiril hydroxyethanesulfonate tablets, combined with HRS-1358 tablets to carry out a clinical trial for breast cancer. Breast cancer is the number one malignant tumor affecting women worldwide. According to the Global Cancer Epidemiology Report 2024, the incidence and mortality rates of breast cancer rank first among female malignant tumors, with approximately 2.31 million new cases of breast cancer and 670,000 deaths globally each year, ranking first in terms of incidence and mortality rates of female malignant tumors [1]. In recent years, the incidence and mortality rates of breast cancer have shown a continuous upward trend in China, and it ranks fourth among the causes of cancer death. HRS-1358 is a novel, highly efficient and ...
- Source: drugdu
- 72
- July 24, 2024
MAXVAX’s recombinant herpes zoster vaccine (CHO cell) enrolled in Phase III clinical trials

On July 13, the Phase III clinical trial of recombinant herpes zoster vaccine (CHO cell) of Chengdu MAXVAX Biotechnology Co., Ltd (MAXVAX) completed the enrollment of the first subject in Liangyuan District, Shangqiu City, Henan Province, marking the successful start of the Phase III clinical trial of the recombinant herpes zoster vaccine of MAXVAX. The vaccine product adopts recombinant protein technology route and carries independently developed new adjuvant system MA105, which is the first innovative vaccine with composite adjuvant system with independent intellectual property rights to enter phase Ⅲ clinical trial in China. The results of Phase I and Phase II clinical trials show that it has good safety, tolerability and immunogenicity. Phase III clinical trials will further verify the safety, immunogenicity and protective efficacy of the vaccine in a large sample of people, providing key data for the product’s marketing application. About Herpes Zoster Vaccine Herpes zoster is a ...
- Source: drugdu
- 56
- July 16, 2024
OLYMVAX Trivalent Influenza Virus Cracking Vaccine (MDCK Cells) Clinical Trial Application Accepted

Recently, the State Drug Administration website announced that it agreed to accept OLYMVAX’s application for clinical trials of trivalent influenza virus lysate vaccine (MDCK cells), which is also the first cell-based trivalent influenza vaccine to be declared for clinical use in China. Influenza vaccination is an effective means of preventing influenza and reducing the burden of influenza-associated severe illness and death. Divided from the components of the vaccine and the types of preventive viruses, the influenza vaccines currently available in China include trivalent influenza vaccine and tetravalent influenza vaccine. Trivalent influenza vaccine mainly prevents H1N1 and H3N2 subtypes of Influenza A, as well as Influenza B Victoria lineage viruses, while tetravalent influenza vaccine is based on trivalent influenza vaccine, with added prevention against Influenza B Yamagata lineage viruses. OLYMVAX’s quadrivalent influenza virus lysate vaccine (MDCK cells) has been approved by the State Drug Administration for the issuance of the Notice ...
- Source: drugdu
- 118
- July 9, 2024
Hengrui Pharmaceuticals’ Innovative Drug HRS-7249 Injection for the Treatment of Hyperlipidemia Approved for Clinical Trials

Recently, Hengrui Pharmaceuticals’ subsidiary Fujian Shengdi Pharmaceutical Co., Ltd. received a Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, which approved HRS-7249 Injection, a Class 1 new drug, to carry out clinical trials for the treatment of hyperlipidemia. Upon inquiry, no similar products have been approved for marketing at home and abroad for the time being. Hypertriglyceridemia (HTG) is a common type of dyslipidemia. Epidemiologic studies have shown that HTG is one of the risk factors for atherosclerotic cardiovascular disease (ASCVD) and acute pancreatitis, and is clearly associated with overweight/obesity, insulin resistance/type 2 diabetes mellitus, non-alcoholic fatty liver disease, and chronic kidney disease. Currently, triglyceride-lowering drugs often used in clinical practice have limited reduction of triglycerides and have adverse effects such as hepatic and renal impairment, increased risk of atrial fibrillation, and decreased insulin sensitivity, and safer and more effective drugs are needed for ...
- Source: drugdu
- 96
- July 8, 2024
Hengrui Pharmaceuticals’ Innovative Drug HRS-9813 Tablets for Treatment of Idiopathic Pulmonary Fibrosis Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals’ subsidiary Guangdong Hengrui Pharmaceuticals Co., Ltd. received the Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, which approved HRS-9813 tablets, a Class 1 new drug, to carry out clinical trials for idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrotic interstitial lung disease of unknown cause, which ultimately leads to hypoxemia, respiratory failure and even death.IPF was included in the first batch of China’s rare disease catalog in 2018, and in recent years, studies have shown that its incidence and prevalence are on the rise globally, and its prognosis is poor, and it is one of the diseases that researchers are currently working to overcome. Currently, there are limited drugs approved for the treatment of IPF at home and abroad, and there are still deficiencies in terms of safety and patient compliance.There is still a huge unmet ...
- Source: drugdu
- 91
- July 8, 2024
FDA shares draft guidance on clinical trial diversity action plans

Dive Brief The Food and Drug Administration published draft guidance on Wednesday for diversity action plans intended to increase enrollment of underrepresented groups in clinical trials. A year-and-a-half after Congress passed legislation requiring clinical trial diversity action plans, the agency explained which device trials must meet the requirements and presented a timeline for implementation. The draft is open for feedback for 90 days, giving sponsors a chance to comment on the FDA’s interpretation of legal requirements such as the need to share enrollment goals in the plans. Dive Insight Congress passed a law in 2022 that would require drug- and device-makers to submit diversity action plans to the FDA. Per the law, the FDA was required to publish draft guidance clarifying the format and content of the diversity action plans by Dec. 29, 2023. In the draft, the FDA says that, while the Act “refers to clinical studies broadly,” it ...
- Source: drugdu
- 106
- July 1, 2024

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