Search Results for “EU” – Page 24 – media

Zhuohe Pharmaceutical’s “Category 1.1 innovative traditional Chinese medicine” was approved for marketing

On February 21, the National Medical Product Administration approved the marketing application pf the innovative traditional Chinese medicine Category 1.1 drug Jiuwei Cough Oral Liquid applied by Zhuohe Pharmaceutical Group Co., Ltd. (hereinafter referred to as “Zhuohe Pharmaceutical”). According to the NMPA official website, a randomized, double-blind, placebo and active drug parallel controlled multi-center clinical trial has been conducted. The results show that in terms of the main efficacy indicators: cough disappearance rate and cough disappearance time the test group is better than the placebo group and non-inferior to the positive drug group. This medicine is used for relieving lungs and cough, acute tracheobronchitis and cough that belongs to wind-heat syndrome according to traditional Chinese medicine. The launch of this drug provides more treatment option for patients with acute tracheobronchitis cough. Anti-rheumatic, anti-tumor… According to Zhuohe Pharmaceutical’s public information, the company has professional R&D and innovation capabilities in multiple disciplines ...
- Source: drugdu
- 149
- February 26, 2024
Update on MHRA safety review of medicines containing pseudoephedrine

Pseudoephedrine is licensed for the symptomatic relief of nasal and sinus congestion in colds, flu, and allergies. It has been used in the UK for decades by millions of people. All pseudoephedrine-containing medicines in the UK are for short term use and taken orally. These come in tablet, capsule, powder, liquid, or syrup form; none of the decongestant nasal sprays authorised in the UK contain pseudoephedrine. There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with pseudoephedrine. These are very rare conditions that can involve inflammation and/or reduced blood supply to the brain, which are recognised as very rare side effects for pseudoephedrine-containing medicines licensed in the UK. Following a careful MHRA review of the latest available evidence, including the assessment of cumulative reporting of adverse drug reaction reports, the safety information of all pseudoephedrine-containing medicines will be updated to ...
- Source: drugdu
- 80
- February 26, 2024
Hengrui Pharmaceuticals’s CD79b ADC Innovative Drug SHR-A1912 Receives U.S. FDA Fast Track Eligibility Recognition

Recently, Hengrui Pharmaceuticals’s self-developed CD79b antibody-drug-conjugate (ADC) innovation SHR-A1912 for injection has been granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphomas (R/R DLLC) that have received at least 2 lines of therapy in the past. SHR-A1912 was granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) that has previously received at least 2 lines of therapy. This is also the 2nd product of the Company to be granted Fast Track status by the FDA. In January this year, the Company announced that its self-developed HER3 ADC innovative drug SHR-A2009 for injection was granted Fast Track status by the FDA for the treatment of metastatic non-small-cell lung cancer (“NSCLC”) with EGFR mutation that has progressed after third-generation EGFR tyrosine kinase inhibitor and ...
- Source: drugdu
- 119
- February 26, 2024
Treadwell Therapeutic’s Novel Acute Myeloid Leukemia Treatment Granted FDA Orphan Drug Designation

Davy James Ocifisertib is a first-in-class, novel PLK4 inhibitor that has demonstrated significant activity as a monotherapy in both solid and liquid tumors. Image credit: Arif Biswas | stock.adobe.com Treadwell Therapeutics’s ocifisertib (CFI-400945) has been granted orphan drug designation by the FDA for the treatment of acute myeloid leukemia (AML).1 The first-in-class, novel PLK4 inhibitor has been found to regulate centriole duplication in patients with AML. “The FDA’s decision to grant orphan drug designation, along with the previous FDA Fast Track designation for ocifisertib, underscores [our] dedication to addressing this patient population with few treatment options. Patients with relapsed and/or refractory AML—in particular TP53-mutated disease—suffer poor overall survival and represents a high unmet clinical need,” said Roger Sidhu, MD, acting CEO of Treadwell Therapeutics, in a press release. The PLK4 enzyme is typically overexpressed in cancer cells and has been associated with adverse survival outcomes. Inhibiting PLK4 has been found ...
- Source: drugdu
- 92
- February 24, 2024
Kangpu Biopharmaceuticals to Present Preclinical Efficacy Data of KPG-818 in Crohn’s Disease at the 19th Congress of ECCO (IND Application for Phase II in Progress)

HEFEI, China, Feb. 20, 2024 /PRNewswire/ — Kangpu Biopharmaceuticals, a clinical-stage company dedicated to the discovery and development of novel therapeutics for the treatment of cancer, autoimmune diseases, and inflammation, through targeted protein degradation technology, today announced that a poster on preclinical efficacy data of KPG-818 in Crohn’s disease will be presented at the upcoming 19th Congress of European Crohn’s and Colitis Organisation (ECCO), taking place in Stockholm, Sweden, February 21-24, 2024. Poster Title: Therapeutic Effects of KPG-818 in a Trinitrobenzene Sulfonic Acid-Induced Mouse Crohn’s/Ulcerative Colitis Model Abstract Number: EC24-0844 Exhibition Zone: Poster Exhibition, Hall A Presentation Number: P131 Crohn’s disease is a chronic and difficult-to-treat autoimmune disorder. The current available therapeutic options for this condition are very limited, and there remain significant unmet medical needs. In preclinical studies, KPG-818 demonstrated potent therapeutic efficacy in mouse model of Crohn’s disease. KPG-818 significantly improved clinical symptoms, colorectitis, ulcers, and local immune ...
- Source: drugdu
- 121
- February 23, 2024
Sperogenix Therapeutics introduced for US$124 million! New drug for Duchenne muscular dystrophy planned to be included in priority review

Today (February 18), the official website of the Center for Drug Evaluation (CDE) of the NMPA of China announced that the vamorolone oral suspension applied by Sperogenix Therapeutics is scheduled to be included in the priority review, and the indication is Duchenne muscle aged 4 years and above. Public information shows that this is a new rare disease drug introduced by Sperogenix Therapeutics from Santhera Pharmaceuticals for US$124 million. It has been approved to treat DMD in the United States and the European Union. It is reported that vamorolone has achieved positive results in the key clinical study VISION-DMD and three open-label studies and expansion studies. In the VISION-DMD study, compared with placebo, the vamorolone group reached the primary endpoint after 24 weeks of treatment, and the difference in the time required from lying to standing was statistically significant compared with the placebo group. Additionally, male patients treated with vamorolone ...
- Source: drugdu
- 134
- February 22, 2024
New Protein Biomarker to Help Develop Blood-Based Tests for Aggressive Neuroendocrine Carcinomas

Neuroendocrine carcinomas, such as neuroendocrine prostate cancer and small-cell lung cancer, originate in hormone-releasing cells and can develop in various organs, including the prostate and lungs. While they are not the most prevalent cancer type in these organs, they often have a poor prognosis and limited therapeutic options. Current treatments for these cancers include chemotherapy, radiation, and immunotherapy combinations. Neuroblastoma, predominantly found in young children, develops from immature nerve cells, often in the adrenal glands or nerve tissue along the spine, chest, abdomen, or pelvis. Despite treatment efforts, these therapies only extend survival by a few months, underscoring the need for better therapeutic targets and less invasive diagnostic approaches for these malignancies. Investigators from the UCLA Health Jonsson Comprehensive Cancer Center (Los Angeles, CA, USA) have identified UCHL1, a protein found in aggressive neuroendocrine carcinomas and neuroblastoma, as a potential molecular biomarker for diagnosing these cancers and predicting and monitoring ...
- Source: drugdu
- 115
- February 19, 2024
Study Advances Blood Tests for Psychiatric and Neurological Disorders

The lack of non-invasive methods for monitoring brain status is a significant challenge in psychiatric care. Using genetic material from human blood and lab-grown brain cells, researchers have now made advances in developing a blood test to detect brain-related changes associated with postpartum depression and other psychiatric and neurological disorders. The research by investigators at Johns Hopkins Medicine (Baltimore, MD, USA) focused on tracing brain cell-derived mRNAs in the bloodstream. These extracellular vesicles (EVs), which are tiny sacs containing genetic material, are crucial for cell communication and carry messenger RNA (mRNA) from the brain. This method allows for the detection of changes in gene activity within the brain. The team’s interest in this area grew from an earlier study that found altered EV communication in pregnant women who developed postpartum depression after childbirth. The latest study used the human placenta as a model to identify 26 placental mRNAs in maternal ...
- Source: drugdu
- 140
- February 19, 2024
Alys Pharmaceuticals announces launch with $100m funding

Alys Pharmaceuticals has announced its launch with a research and development (R&D) immuno-dermatology focused pipeline backed by a $100m financing from Medicxi. Co-founded by Medicxi and a team of dermatology and scientific specialists, Alys Pharmaceuticals is led by co-founder and COO Thibaud Portal, with Medicxi’s Francesco De Rubertis serving as board chairman. The company’s pipeline is powered by multiple platform technologies, targeting a range of dermatological ailments. Its goal is to transform the dermatological treatment landscape, focusing on conditions such as atopic dermatitis, vitiligo, alopecia areata and chronic spontaneous urticaria. Alys Pharmaceuticals’ pipeline also includes programmes for less common ailments such as mastocytosis and cutaneous T-cell lymphoma, and therapies to prevent skin side effects from cancer treatments. The company is partnering with establishments including the Institut Gustave Roussy and UMass Chan Medical School to advance its collaborative R&D. Alys Pharmaceuticals integrates the platforms and assets from six Medicxi companies: Aldena ...
- Source: https://www.pharmaceutical-technology.com/news/alys-pharmaceuticals-announces-launch/?cf-view
- 78
- February 13, 2024
Study reveals SARS-CoV-2 can infect dopamine neurons causing senescence

Dopamine neuron senescence is a hallmark of Parkinson’s disease Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center and Columbia University Vagelos College of Physicians and Surgeons have reported that SARS-CoV-2 can infect dopamine neurones in the brain, triggering senescence. Long COVID patients should be monitored for an increased risk of developing Parkinson’s disease (PD)-related symptoms, as dopamine neuron senescence is a hallmark of the condition. The study revealed that dopamine neurons that are infected with SARS-CoV-2, the virus that causes COVID-19, stop working and send out chemical signals that cause inflammation, triggering senescence, when a cell loses the ability to grow and divide. Neurons produce dopamine, a neurotransmitter that acts on areas of the brain and causes feelings of pleasure, motivation, memory, sleep and movement. Damage to these neurons is also associated with PD, a neurodegenerative disorder that progressively damages parts of the brain. After generating multiple cell types from ...
- Source: https://news.weill.cornell.edu/news/2024/01/sars-cov-2-can-infect-dopamine-neurons-causing-senescence
- 167
- February 12, 2024

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