PharmaFocus Today – Page 64 – media

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
- 92
- 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
- 92
- July 25, 2024
ANKE Bio received clinical approval for another therapeutic mRNA vaccine

ANKE Bio (Group) Co., Ltd. and Hefei Alfana Biotechnology Co., Ltd. jointly developed a Class 1 new drug that received clinical approval from the Drug Administration (Drug Clinical Trial Approval Notification: 2024LP01608), with an indication for the treatment of cervical intraepithelial neoplasia. It is reported that this is the first therapeutic mRNA vaccine approved for clinical use in cervical intraepithelial neoplasia in China. Pre-cancerous lesions and their eventual malignant changes caused by viral infections are a serious threat to people’s lives and health. Globally, approximately 600 million people are infected with human papillomavirus (HPV), in addition to approximately 250 million people infected with hepatitis B virus (HBV), and 71 million people infected with hepatitis C virus (HCV). People infected with each of these viruses face a potential cancer risk. For example, approximately 30 million women are diagnosed each year with cervical intraepithelial neoplasia (CIN), an important precursor to cervical cancer. ...
- Source: drugdu
- 82
- July 25, 2024
Telix raises $398m to advance kidney and brain cancer radiotherapies

Not long after pulling a last-minute plug on a $232m initial public offering (IPO) on Nasdaq, Telix Pharmaceuticals has raised $398m (A$600m) via the issue of convertible bonds. The bonds, which are convertible into ordinary shares, will yield a 2% – 2.75% interest, the radiopharmaceutical specialist said in a 23 July press release. The maturity date is set for five years from now, at the end of July 2029. Australia-based Telix said it intends to list the convertible bonds on the Official List of Singapore Exchange Securities Trading Limited (SGX-ST). While Telix had been planning on going public on Nasdaq earlier this year, the company U-turned on the IPO citing market conditions at the time. Telix had been on course to raise $232m in the listing, though the company maintained that the decision was not “predicated on the need to raise capital”. Instead, the convertible bonds bring low-cost financing to ...
- Source: drugdu
- 63
- July 25, 2024
J&J drops Addex’s epilepsy treatment after flunking in Phase II

Johnson and Johnson (J&J) Innovative Medicine has decided to halt the development of its epilepsy drug, three months after a Phase II trial with the drug failed to meet its endpoints. The therapy was developed in partnership with Addex Therapeutics, which was quick to add that its collaboration with J&J is still ongoing as the companies analyse data from the placebo-controlled Phase II trial (NCT04836559). The drug failed to achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count. Addex’s stock has not recovered from the 53.3% nosedive it took after the Phase II results were released on 29 April. The company’s stock is now trading at $8.06 on the Nasdaq, down 49.9% from what it was worth before the news of Phase II results was announced. ADX71149 is a positive allosteric modulator (PAM) of metabotropic glutamate receptor-2 (mGlu2 receptor), which plays a key ...
- Source: drugdu
- 91
- July 25, 2024
Screening Tool Detects Multiple Health Conditions from Single Blood Drop

Infrared spectroscopy, a method using infrared light to study the molecular composition of substances, has been a foundational tool in chemistry for decades, functioning similarly to a molecular fingerprinting system via a device known as a spectrometer. When utilized on complex biofluids like blood plasma, this physico-chemical technique provides in-depth molecular insights, indicating its potential for medical diagnostics. Despite its established role in chemistry and industry, infrared spectroscopy has yet to become a standard tool in medical diagnostics. To tackle this issue, scientists have developed a diagnostic tool that employs infrared light and machine learning to identify multiple health conditions in just one measurement at the population level. The team from the BIRD group at Ludwig Maximilian University of Munich (LMU, Munich, Germany) had previously worked on methods to measure human plasma. In their most recent study, they introduced infrared molecular fingerprinting to a naturally diverse group, analyzing blood from ...
- Source: drugdu
- 107
- July 24, 2024
Computational Tool Integrates Transcriptomic Data for Improved Breast Cancer Diagnosis and Treatment

Breast cancer is the most commonly diagnosed cancer globally, presenting in various subtypes that require precise identification for effective, personalized treatment. Traditionally, cancer subtyping has been conducted through histological staining (immunohistochemistry), which involves identifying specific markers that categorize tumors into distinct subtypes. Recently, high-throughput transcriptomic profiling has transformed the way breast cancer subtypes are identified by analyzing gene activity in cancer cells through the total messenger RNAs present, which correspond to gene sequences and are used by ribosomes to synthesize proteins. Transcriptomic profiling utilizes RNA sequencing (RNAseq), a rapidly evolving molecular biology technique that sequences RNA strands efficiently. As RNA sequencing becomes more affordable, it holds the potential for routine clinical integration to aid in diagnosis and treatment decisions. However, its application is currently limited by the requirement for processing large sample batches simultaneously and difficulties in comparing samples across different platforms. Now, scientists have developed a computational tool that ...
- Source: drugdu
- 72
- July 24, 2024
Johnson & Johnson Submits Supplemental New Drug Application to FDA for Spravato as Monotherapy for Adults with Treatment-Resistant Depression

By Don Tracy, Associate Editor Approval of Spravato would mark the first monotherapy to be available on the market for treatment-resistant depression in the United States.Johnson & Johnson (J&J) has submitted a supplemental New Drug Application (sNDA) to the FDA for the approval of Spravato (esketamine) as the first and only monotherapy for the treatment of treatment-resistant depression (TRD). According to the company, the sDNA is supported by encouraging data from the Phase IV TRD4005 trial, which evaluated the efficacy, safety, and tolerability of Spravato as a monotherapy. “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” said Bill Martin, PhD, global therapeutic area head, neuroscience, Johnson & Johnson Innovative Medicine, in a press release. “We’re pleased to build on the more than a ...
- Source: drugdu
- 93
- July 24, 2024
Neuro Drug Passed Up by Biogen Posts Positive Data for Ionis, Setting Stage for Phase 3 Test

Ionis Pharmaceuticals is looking ahead to a Phase 3 study for an antisense medicine it is developing to treat Angelman syndrome, a rare neurodevelopmental disorder with no FDA-approved therapies. Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year. By Frank VinluanAn Ionis Pharmaceuticals drug in development for Angelman syndrome has mid-stage clinical trial results showing improvement across a range of measures of this rare neurodevelopmental disorder, and the company now plans to advance therapy to Phase 3 testing. Angelman is an inherited disorder that presents in infancy and leads to learning disability, muscle impairment, balance problems, and seizures. Patients typically develop little to no verbal ability. While Angelman patients can be treated with drugs that manage some of these symptoms, there are no FDA-approved therapies for the disease itself. The results announced Monday for the drug, ION582, come from the multiple-ascending dose portion of ...
- Source: drugdu
- 79
- July 24, 2024
SINOPHARM’s first batch of antibody products officially shipped! Will bring new treatment options for lymphoma patients

On July 22, the first batch of SINOPHARM’s first antibody drug Sanglijian® (rituximab injection) was officially shipped, marking the company’s antibody drug formally entered a new journey of commercialization. Patient’s Gospel, First-line Targeted Drugs for Hematologic Tumors Lymphoma is a malignant tumor originated from lymphohematopoietic system, which belongs to immune system diseases. Malignant lymphoma is mostly non-Hodgkin’s lymphoma, accounting for about 80%-90% of all lymphoma cases. According to the data released by the National Cancer Center, the current incidence rate of lymphoma in China is about 6/100,000, with nearly 100,000 new cases every year, causing serious harm to patients’ lives, health and quality of life. Sanglijian® (rituximab injection) is mainly used for the treatment of non-Hodgkin’s lymphoma (follicular non-Hodgkin’s lymphoma, CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma), chronic lymphoma cell leukemia (CLL) indications, and it is the first-line targeted drug of hematological tumors. According to the research, SUNLIFE® combined with CHOP ...
- Source: drugdu
- 93
- July 24, 2024

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