Search Results for “Clinical Trial” – Page 70 – media

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
- 170
- 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
- 82
- 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
- 92
- February 27, 2024
【EXPERT Q&A】What is the FDA registration review process for medical devices?

Drugdu.com expert’s response: The FDA registration review process for medical devices involves the following key steps: 1.Determine Product Classification: Firstly, the classification of the medical device needs to be determined, i.e., identifying which category it falls under in the FDA’s classification system. FDA categorizes medical devices into three classes: Class I, Class II, and Class III. The registration review process and requirements may vary depending on the device’s classification. 2.Prepare Registration Application: Prepare a comprehensive registration application package according to FDA requirements, including product description, technical specifications, design files, clinical trial data (if applicable), quality management system documentation, manufacturing process documentation, etc. 3.Submit Registration Application: Submit the complete registration application package to the FDA. Typically, this is done through the FDA’s electronic registration system, the FDA Unified Registration and Listing System (FURLS). 4.Registration Review: The FDA reviews the submitted registration application. During the review process, the FDA may request further information ...
- Source: drugdu
- 148
- 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
- 131
- 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
- 140
- 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
- 110
- February 26, 2024
Wireless Hepatitis B Test Kit Completes Screening and Data Collection in One Step

Hepatitis B, a significant global health concern, is responsible for chronic liver diseases like cirrhosis and liver cancer which is one of the most common cancers worldwide. The challenge with hepatitis B is that most carriers are asymptomatic, remaining unaware of their infection, which can lead to its unintentional spread. Thus, early diagnosis is vital to halt the spread, initiate timely treatment, and reduce the risk of liver complications primarily caused by the hepatitis B virus. However, conventional tests for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) are complex, requiring specialized skills and large, expensive machine-based assays typically found in major hospitals. To overcome the problem of inadequate access to screening for Hepatitis B, researchers have developed a wireless, point-of-care test for the Hepatitis B Virus that can make diagnosis simpler and faster. Researchers from Chulalongkorn University (Bangkok, Thailand) have developed a testing kit that enables ...
- Source: drugdu
- 92
- February 22, 2024
Adverse Event Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

The FDA clinical hold follows a a report of liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule. By FRANK VINLUAN Rapt Therapeutics aim to bring patients oral alternatives to injectable or infused immunology medications has hit a setback. A Rapt drug candidate in mid-stage clinical development in atopic dermatitis and asthma has been placed under an FDA clinical hold after a serious adverse event reported in a study participant, the company announced Tuesday. The patient, a participant in the atopic dermatitis study, experienced liver failure. According to Rapt, the cause of the liver failure is unknown but has been characterized as potentially related to the company’s experimental drug, zelnecirnon. South San Francisco-based Rapt said the FDA verbally notified the ...
- Source: drugdu
- 153
- February 22, 2024
Hengrui Medical made a new breakthrough in the field of medical nuclide preparation and successfully prepared 64Cu in batch.

Recently, Hengrui Medical ushered in a new breakthrough in the field of medical nuclide preparation, and its subsidiary Tianjin Hengrui Medical Co., Ltd. has realized the independent mass production of copper chloride [64Cu] solution with stable and controllable quality through independent projects and technological research, and the PET imaging of the labeled drug is good for small animals. This breakthrough of Hengrui Medicine lays the foundation for the development of 64Cu-labeled diagnostic drugs, and can also provide the industry with the nuclide for the R&D and production of such drugs. In 2021, eight national ministries and commissions jointly issued the Medium- and Long-term Development Plan for Medical Isotopes (2021-2035), which explicitly pointed out that 64Cu is an isotope with broad application prospects, and the key technology of gas pedal preparation of 64Cu is the key task of the plan. Radiopharmaceuticals refer to a special class of drugs containing radionuclides for ...
- Source: drugdu
- 130
- February 22, 2024

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