PharmaFocus Today – Page 157 – media

Subsidiary of Zhengda Tianqing Passed FDA’s On-site Inspection with “Zero Defect” for Three Consecutive Times

Recently, Lianyungang Runzhong Pharmaceutical, a wholly-owned subsidiary of Zhengda Tianqing Pharmaceutical Group, passed the on-site inspection of the U.S. Food and Drug Administration (FDA) with “zero defects”, which means that the company’s quality management system has once again been recognized by international authoritative drug regulatory agencies. Previously, Runzhong Pharmaceutical has passed the FDA on-site inspection with zero defects twice in 2014 and 2018. FDA is recognized as one of the most authoritative and strict agencies in the world for drug quality supervision.2024 From January 22 to January 26, FDA conducted pre-approval inspections on two antineoplastic products of Runzhong Pharmaceuticals, as well as supervisory inspections on four products commercialized in the U.S. market, namely, aminophosine, fosaprepitant dimeglumine, phosphonate, and fulvestrant. At the final meeting on January 26, the inspector announced on-site that R&Z passed the inspection with zero defects. It is understood that during this on-site inspection, the FDA inspector conducted ...
- Source: drugdu
- 93
- February 27, 2024
Dupixent® Receives Another FDA Priority Review for Chronic Obstructive Pulmonary Disease (COPD) with Type 2 Inflammation

Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of Dupixent (dupliximab) for a sixth potential indication as a supplemental biologic. Sanofi announced today that the U.S. Food and Drug Administration (FDA) has granted priority review of the Supplemental Biologics License Application (SBLA) for the sixth potential indication for dabigatran (duplizumab), an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The FDA approval is expected on June 27, 2024. China has also submitted a marketing authorization application and received acceptance from the Center for Drug Evaluation (CDE) of the State Drug Administration (SDA). Data from two Phase III clinical trials (BOREAS and NOTUS) supporting this SBLA and other applications globally evaluated the efficacy and safety of Dupixent in adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation who are smokers or have a history of ...
- Source: drugdu
- 174
- February 27, 2024
February 23, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma. The agency determined the following grounds for withdrawal were met: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit, and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use. The final decision was issued by the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., as the Commissioner’s designee. The decision is effective immediately. The FDA plans to publish a Federal Register notice announcing the availability of today’s decision and remove Pepaxto from the Orange Book. It is the FDA’s ...
- Source: drugdu
- 83
- February 27, 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
- 94
- February 27, 2024
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
- 189
- 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
- 159
- 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
- 174
- 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
- 142
- 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
- 137
- 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
- 145
- February 26, 2024

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