PharmaFocus Today – Page 187 – media

Simple Blood Test Quickly and Accurately Diagnoses Potentially Life-Threatening Inflammatory Disease

Sarcoidosis, a chronic inflammatory condition characterized by small lumps known as granulomas in the lungs and other organs, remains a medical mystery with its exact cause yet to be understood. Current theories suggest it might be an immune disorder triggered by specific antigens, usually foreign substances that provoke an immune response. Diagnosing sarcoidosis is currently a complex process that typically involves tissue removal and testing, accompanied by additional screenings to exclude other conditions like tuberculosis or lung cancer. Now, researchers have developed a tool that uses a simple blood test to rapidly and inexpensively diagnose sarcoidosis, potentially reducing the need for more invasive diagnostic techniques presently used to detect the disease. In a research project supported by the National Institutes of Health (NIH, Bethesda, MD, USA), researchers at Wayne State University (Detroit, MI, USA) set out to identify antigens and determine which might be linked to sarcoidosis. They collected lung ...
- Source: drugdu
- 234
- February 26, 2024
State-Of-The Art Techniques to Probe Bacterial Cause Of Deadly Strep A Infections

Annually, a staggering half a million people, including numerous children and young individuals, succumb to serious infections caused by the group A streptococcal (Strep A) bacteria globally. Strep A is highly transmissible and spreads from person to person mostly via the respiratory route from sore throats. Strep A is typically known for causing sore throats and skin infections in younger children. However, both groups are very susceptible to the invasive form of the infection. In rare cases, it can lead to more severe conditions like sepsis and toxic shock if the bacteria invade the bloodstream or tissue. A particularly alarming consequence of repeated Strep A infections is the autoimmune-induced damage to heart valves, termed rheumatic heart disease (RHD). RHD affects approximately 50 million people worldwide, predominantly in middle- and low-income countries. Currently, there is no vaccine available for Strep A. The development of immunity to Strep A over time, including ...
- Source: drugdu
- 185
- February 26, 2024
Study Finds Parkinson Disease Drug Nearly Matches Wegovy in Weight Loss Effects

Don Tracy, Associate Editor Early-stage trial results indicate that NLRP3 inflammasome inhibitors were able to achieve nearly the same weight loss as Wegovy while also reducing inflammatory biomarkers linked to heart disease. Results from an early-stage study found that a novel therapy for Parkinson disease produced nearly the same weight loss effect as the blockbuster GLP-1 receptor agonist Wegovy (semaglutide), while also lowering inflammatory biomarkers associated with heart disease. In a study published by The Journal of Pharmacology and Experimental Therapeutics, researchers for NodThera, a clinical-stage biotech developing brain-penetrant NLRP3 inhibitors to treat chronic inflammatory diseases, aimed to discover the efficacy of the investigational NLRP3 inflammasome inhibitors NT-0249 and NT-0796 in reversing obesity-related complications. They focused on systemic inflammation and astrogliosis in the hypothalamus. To find a sufficient answer, the study relied on diet-induced obesity (DIO) mouse models treated with NT-0249 and NT-0796 to assess their impact on obesity reversal. ...
- Source: drugdu
- 232
- February 26, 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
- 175
- February 26, 2024
Hengrui’s CD79b ADC innovative drug SHR-A1912 received FDA fast track qualification

Recently, SHR-A1912, an innovative CD79b antibody-drug-conjugate (ADC) drug for injection independently developed by Hengrui, 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 received at least two lines of therapy in the past. This will help accelerate the advancement of clinical trials and marketing registration. This is also the company’s second product to obtain fast tracks designation from the US FDA. In January this year, the company announced that its independently developed HER3 ADC innovative drug SHR-A2009 for injection has been granted fast track designation by the FDA for the treatment of third-generation EGFR-positive tumors, EGFR-mutated metastatic non-small cell lung cancer (NSCLC) with disease progression after amino acid kinase inhibitors and platinum-containing chemotherapy. Previously, the clinical trial application of SHR-A1912 for the treatment of B-cell non-Hodgkin lymphoma has been implicitly approved ...
- Source: drugdu
- 168
- February 26, 2024
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
- 181
- February 26, 2024
Innovent and ImmVirX Enter into Clinical Trial Collaboration to Investigate the Combination of IVX037 and Sintilimab in Difficult-to-treat Cancers

ROCKVILLE, M.D. and SUZHOU, China, February 21，2024 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that it has entered into a clinical trial collaboration and supply agreement with ImmVirX Pty Limited (“ImmVirX”) to evaluate the combination therapy of ImmVirX’s investigational oncolytic virus IVX037 with Innovent’s TYVYT® (sintilimab injection), the Chinese market-leading anti-PD-1 inhibitor. ImmVirX is conducting a first-in-human Phase 1 clinical trial (NCT05427487) of intratumoral IVX037 in Australia. Initial results from Part 1a of the trial indicate that multiple injections of IVX037 have been well tolerated and show early signs of inducing potentially beneficial inflammatory cytokines/chemokines, such as CXCL10, with antitumor activity observed in the injected lesions of some subjects. Part 1b of the trial, set to begin in mid-2024, evaluates the anticancer activity ...
- Source: drugdu
- 176
- 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
- 89
- 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
- 173
- February 26, 2024
China’s First Domestic Dual-Target Gout Inhibitor (THDBH151 Tablet) Reaches Primary Endpoint in Phase I Clinical Trial

Dong Bao Zi Xing Ltd., a wholly-owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. (the “Company”), has recently completed a pivotal Phase I clinical trial of a dual-target XO/URAT1 inhibitor for gout (THDBH151 tablets) and obtained a clinical trial summary report, which shows that the study results have reached the primary endpoint. The results of the study showed that the primary endpoints were met. The results of the “Phase I Clinical Study of the Safety, Tolerability, Pharmacogenetics/Pharmacodynamics and Effect of Food of THDBH151 Tablets in Healthy Adult Subjects with Single and Multiple Doses” conducted by the Company showed that the product was safe and well-tolerated in healthy Chinese adult subjects, with overall adverse event rates similar to or slightly lower than those of placebo, and that all adverse events were similar to or lower than those of placebo. The overall adverse event rate was similar to or slightly lower than ...
- Source: drugdu
- 149
- February 26, 2024

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