Search Results for “EU” – Page 23 – media

Researchers develop brain-age prediction tool for diagnosis of neurological diseases

The non-invasive tool can also improve patient stratification and monitor disease progression Researchers from King’s College London (KCL) have developed a deep learning framework for a non-invasive brain-age prediction tool for the early diagnosis of neurological diseases. The study built and made available a set of models for clinical use after training multiple brain models from a variety of magnetic resonance image (MRI) types. Neurological disorders, such as Alzheimer’s disease, strokes, multiple sclerosis and Parkinson’s disease, are conditions that affect the brain as well as the nerves found throughout the human body and spinal cord. By comparing patients’ brain ages against their chronological ages, numerous neurological and psychiatric conditions can be identified, helping to predict future health outcomes for patients. Researchers collected over 81,000 patients’ head MRI examinations from Guy’s and St Thomas’ NHS Foundation Trust and King’s College Hospital NHS Foundation Trust between 2008 and 2019. After pre-training models, ...
- Source: drugdu
- 89
- March 7, 2024
FDA Clears Quoin Pharmaceuticals to Employ Teens for Netherton Syndrome Clinical Trials

Don Tracy, Associate Editor Teens to be included in both placebo and open label studies for QRX003, a potential treatment for Netherton syndrome. Today, Quoin Pharmaceuticals announced that the FDA has given approval to include teenagers aged 14 years and older in two ongoing clinical trials for QRX003, a potential treatment for Netherton syndrome (NS). According to a press release, this marks the first time that teen patients with NS will have the opportunity to participate in clinical trials under an Investigational New Drug Application (IND). Additionally, the studies will accommodate teens currently on off-label systemic therapy, with the focus of generating comprehensive data for QRX003’s development.1 “We are very pleased to announce this exciting development, not just for Quoin’s clinical program, but for the Netherton community as a whole,” said Michael Myers, BSc, PhD, CEO, Quoin, in a press release. “We are frequently petitioned by parents and caregivers that ...
- Source: drugdu
- 113
- March 6, 2024
AbbVie and OSE Immunotherapeutics Announce Collaboration to Develop Novel Monoclonal Antibody for the Treatment of Chronic Inflammatory Diseases

On February 28, 2010, AbbVie and OSE Immunotherapeutics, an immunotherapeutics company, announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to address serious chronic inflammatory diseases, which is currently in preclinical studies. OSE-230 is a first-of-its-kind monoclonal antibody designed to activate the G protein-coupled receptor (GPCR) target ChemR23, which may provide a novel mechanism for relieving chronic inflammation by regulating macrophage and neutrophil function. Dr. Jonathon Sedgwick, Senior Vice President and Global Head of Discovery Research at AbbVie, said: “This collaboration underscores our commitment to expanding our immunology portfolio, with the ultimate goal of raising the standard of care for patients suffering from inflammatory diseases worldwide. We look forward to applying our expertise in immunology drug development to advance the development of OSE-230. Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, said: “We are pleased to partner with AbbVie, a global leader in the development and commercialization of ...
- Source: drugdu
- 84
- March 6, 2024
Interphex —NewYork biopharmaceutical Exhibition

Organiser: American pharmaceutical association Time:16 – 18 April 2024 address：655 West 34th Street New York, NY 10001-1188 USA Exhibition hall: Javits Convention Center, NYC Product range: Analytical instruments, automation and process control, batch processing systems/equipment, biological process equipment, packaging equipment, process equipment and parts, pilot plant equipment and custom components, tablet/capsule filling machine facility engineering and maintenance, environmental treatment and equipment, clean room equipment; Processing systems, control systems, automation instruments, pharmaceutical packaging materials, containers, etc About Interphex： The New York Biopharmaceutical Exhibition (Interphex) is one of the largest pharmaceutical exhibitions in North America. Held since 1979, it is the most trusted life science show in North America across both chemical and biopharmaceutical fields. Exhibitors meet decision buyers from the world’s top pharmaceutical companies through the exhibition.
- Source: drugdu
- 194
- March 5, 2024
Biotheus’s PD-L1/VEGF dual antibody is planned to be included in breakthrough therapeutic category and has reached a licensing cooperation of over US$1 billion

Today (1st March), the official website of the Center for Drug Evaluation (CDE) of the NMPA announced that the PM8002 injection applied by Biotheus is planned to be included in the breakthrough therapy category, and the indication is the first-line treatment of inoperable locally advanced/recurrent metastatic triple-negative breast cancer with albumin-bound paclitaxel for combined injection. Public information shows that PM8002 is an anti-PD-L1/VEGF bispecific antibody independently developed by Biotheus. BioNTech has reached a cooperation agreement of more than US$1 billion with Biotheus to obtain the development, production and commercialization rights of this product worldwide (except Greater China). PM8002 is a bispecific antibody drug candidate consisting of a humanized anti-PD-L1 mono-antibody (VHH) fused to an anti-VEGF-A IgG1 antibody containing an Fc-silent mutation. This design can enrich PM8002 molecules into the tumor environment and reduce the systemic side effects caused by systemic VEGF blockade. According to an earlier press release fromBiotheus, PM8002 ...
- Source: drugdu
- 129
- March 5, 2024
Allecra Therapeutics’ Exblifep Approved by FDA for Complicated Urinary Tract Infections

Davy James The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act. The FDA has approved Allecra Therapeutics’ Exblifep (cefepime/enmetazobactam) for the treatment of complicated urinary tract infections (cUTIs), including the kidney infection pyelonephritis, in patients aged 18 years and older.1 The FDA also granted Allecra with a five-year marketing exclusivity extension for the β-lactam/β-lactamase inhibitor combination through the Generating Antibiotic Incentives Now Act (GAIN Act), which is legislation that incentivizes the development of new anti-infective treatments. “Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals. I extend my sincere congratulations to my colleagues Omar Lahlou and Patrick Velicitat for their leadership and oversight throughout this whole process,” Iain Buchanan, supervisory board member of Allecra Therapeutics, said in a press release. “As ...
- Source: drugdu
- 118
- February 29, 2024
Hengrui Pharmaceuticals’ PD-L1 Inhibitor Adebelizumab Combined with HER2 ADC SHR-A1811 Approved for Breast Cancer Clinical Treatment

Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved by the State Drug Administration, which authorizes the company to carry out the clinical trial of adelberizumab in combination with SHR-A1811 for the treatment of breast cancer. According to the data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world’s number one malignant tumor and is the most common malignant tumor in women. Statistics show that in 2020, there were about 2.26 million newly diagnosed cases of female breast cancer and 685,000 deaths worldwide, ranking first in female malignant tumor morbidity and mortality. The incidence and mortality rates of breast cancer worldwide vary according to regional distribution. In China, the 2020 China Cancer data show that the incidence rate of breast ...
- Source: drugdu
- 137
- February 29, 2024
Qyuns Therapeutics passed the IPO hearing on the Main Board of the Hong Kong Stock Exchange

According to the Hong Kong Stock Exchange, on February 26, Jiangsu Qyuns Therapeutics-B passed the IPO hearing on the main board of the Hong Kong Stock Exchange and will be listed soon. It is reported that Qyuns Therapeutics was established in 2015. It is a clinical-stage biotechnology company completely focused on biotherapeutics of autoimmune and allergic diseases, covering four major disease areas: skin, rheumatism, respiratory and digestive tract diseases. According to its official website, based on its complete independent innovation capabilities, Qyuns Therapeutics has formed two core products, QX002N and QX005N, as well as a product pipeline of seven other drug candidates. One variety has been accepted by BLA, one is in clinical phase 3, and four varieties are in clinical phase 2 and 1 respectively. The indications cover silver eyebrow disease, atopic dermatitis, ankylosing spondylitis, systemic lupus erythematosus, It covers four major disease areas including asthma, inflammatory bowel disease, ...
- Source: drugdu
- 100
- February 28, 2024
The first patient has been dosed, and the latest progress of Abbisko Therapeutics’s new generation EGFR Exon20ins inhibitor ABSK112

On February 23, 2024, Abbisko Therapeutics announced that its independently developed new-generation EGFR Exon20ins inhibitor ABSK112 has completed the first patient administration in its Phase I clinical trial for non-small cell lung cancer (NSCLC). Previously, ABSK112 has obtained clinical research licenses from China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA), and is conducting Phase I clinical trials simultaneously in China and the United States. ABSK112 is a new generation of EGFR Exon20ins oral inhibitor with high activity, high selectivity and brain entry properties. Compared with the previous generation of EGFR Exon20ins inhibitors that have been on the market or entered clinical trials, ABSK112 has demonstrated better brain entry properties, high selectivity against wild-type EGFR, and broader Exon20ins mutation coverage in preclinical studies. It has shown excellent in vivo efficacy in multiple mouse tumor models with EGFR Exon20ins mutations. It has the potential to obtain ...
- Source: drugdu
- 98
- February 27, 2024
Sanofi, Denali Neuro Drug Fails Mid-Stage Trial in ALS; MS Study Is Continuing

Sanofi, which is leading development of the Denali Therapeutics-partnered molecule, disclosed little about the clinical trial results in ALS. But this Phase 2 failure follows the 2020 clinical trial pause of a different partnered molecule that addresses the same target. By FRANK VINLUAN Amyotrophic lateral sclerosis develops through multiple pathways, so drug research in this neuromuscular disorder has pursued multiple targets. One of those targets faces some doubts after an ALS drug candidate from partners Sanofi and Denali Therapeutics failed to meet the goal of a mid-stage clinical trial. Denali disclosed the Phase 2 clinical trial failure in a Friday regulatory filing. The South San Francisco-based biotech said Sanofi informed it that the brain-penetrating drug, known at Denali as DNL788 and renamed SAR443820 by the pharmaceutical giant, did not meet the main endpoint of showing a change in the ALS Functional Rating Scale-Revised, a scoring assessment for evaluating symptoms in ...
- Source: drugdu
- 150
- February 26, 2024

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