PharmaFocus Today – Page 65 – media

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
- 108
- 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
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
- 78
- July 24, 2024
Glasgow scientists develop first bone marrow model to support human stem cells

Scientists from the University of Glasgow have developed the first bioengineered bone marrow model that supports human stem cells, which are crucial for bone marrow transplants and in vitro study work. Published in Nature Communications, the new model replicates the key aspects of the human bone marrow microenvironment to support rare long-term haematopoietic stem cells (LT-HSCs). Estimated to cause more than 300,000 deaths worldwide every year, leukaemia is a type of blood cancer that affects the white blood cells in the bone marrow, the spongy tissue found inside some bones, where the body makes blood cells. LT-HSCs are a type of cell that can replenish the blood cells after treatment for blood cancers, such as leukaemia. However, due to culturing challenges, researchers often rely on non-human animal models to test drugs that can have effects on blood cell production and target blood diseases. “Currently used animal models are poor predictors ...
- Source: drugdu
- 72
- July 24, 2024
+ Study finds pain gene affects success of chronic pain medicine in women

A study led by the University of Edinburgh in collaboration with the University of Oxford has found that a pain gene carried by women with chronic pelvic pain makes them more likely to respond well to Pfizer’s painkilling drug, Neurontin (gabapentin). Published in the journal iScience, the study found that women carrying a naturally occurring variation of the gene called Neuregulin 3 in their DNA were more likely to experience relief after taking Neurontin. Chronic pelvic pain is a persistent, disabling pain that affects around one in four women globally. Often prescribed for chronic pain, Neurontin is designed to target the central nervous system to reduce the heightened pain sensitivity that affects people living with long-standing conditions. After studying the genetic make-up of 71 women living with chronic pelvic pain who had received Neurontin, researchers found that 29 women responded to the medication, while 42 saw no improvement. The team ...
- Source: drugdu
- 82
- July 24, 2024
Exhaled-Breath Test Shows Promise for Detection of Lung Cancer

Researchers are advancing the development of an exhaled-breath test to detect lung diseases, including lung cancer. Two pivotal studies published in the Journal of Extracellular Vesicles detail their success in isolating and analyzing lung biomarkers from human breath and utilizing animal models to further explore and possibly identify crucial markers for the early and non-invasive detection of metastatic lung tumors. While substantial efforts are needed to identify a spectrum of biomarkers and validate their clinical relevance for human patients, these publications provide a scientific framework for continued research. The research by scientists at Hackensack Meridian Health (Edison, NJ, USA) focuses on capturing and characterizing extracellular vesicles (EVs), nanoparticles released by cells into fluids like blood and serum. Cancer cells release these particles abundantly, making them prime targets for early disease detection. The researchers have initiated biomarker discovery projects for several cancers, including lung, prostate, cervical, and bladder cancers, using liquid ...
- Source: drugdu
- 91
- July 23, 2024

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