Search Results for “EC” – Page 46 – media

Everest Medicines’ Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®

SHANGHAI, March 12, 2024 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”)’s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023. Following full approval in December 2023, Nefecon® is indicated “to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression”. The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN. “We congratulate our partner for receiving seven more years of market exclusivity for Nefecon® in the ...
- Source: drugdu
- 94
- March 15, 2024
BIO-THERA’s BAT8008 (ADC-Trop2) for injection in combination with BAT1308 (PD-1) for the treatment of advanced solid tumors was approved for Phase IB-II clinical trial.

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), a global science-based and innovative biopharmaceutical company located in Guangzhou, China, is hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration of the People’s Republic of China (“SDA”), which approved the application for Phase IB-II clinical trial of BAT8008 for injection in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an antibody-drug coupling (ADC) developed by BIO-THERA to target Trop2, a tumor-associated calcium signal transducer (TACSTHERA), to be developed for the treatment of solid tumors. Trop-2 (Trophoblast cell-surface antigens 2, Trop2), a member of the tumor-associated calcium signal transducer (TACSTD) family of genes, is involved in the regulation of intracellular calcium concentration.Trop2 is not expressed or is lowly expressed in normal human tissues, but is highly expressed in a variety ...
- Source: drugdu
- 184
- March 15, 2024
【EXPERT Q&A】How to handle the Class II medical device management record, what materials need to handle?

Drugdu.com expert’s response: To apply for the record-filing of the distribution of Class II medical devices, the following materials are usually required: 1.Copy of the enterprise’s business license; 2.Medical Device Distribution License; 3.Identification of the legal representative; 4.Product registration certificate or record-filing certificate; 5.Quality management system documentation for medical devices; 6.Labels and instructions for medical device products; 7.Qualification certificates for sales personnel; 8.Proof of relevant premises use; 9.Other relevant documents that may be required. The required materials may vary depending on specific local requirements and regulations. It is advisable to consult the local medical device regulatory authority for the latest application guidelines and the list of required materials before proceeding with the record-filing process.
- Source: drugdu
- 132
- March 15, 2024
KCL joins new project launched by European consortium to improve newborn health

The HYPIEND project consists of 14 partners from eight European countries King’s College London (KCL) has announced that it is one of 14 partners from eight European countries to join the HYPIEND project to improve newborn health. Co-ordinated by the Eurecat technology centre, the five-year study aims to reduce the impact of endocrine disruptors on pregnancy and pre-puberty. Endocrine-disrupting chemicals (EDCs) can be found in products including cosmetics, food, drink and cleaning products. Particularly during pregnancy, infancy and childhood, these products can affect the operation of the hormonal system. The HYPIEND project will analyse the impact on the hypothalamic-pituitaryaxis, the structure where the central nervous system and the endocrine systems connect and regulate hormones that operate body functions such as somatic growth, lactation and stress coping. The project will involve Dr Marika Charalambous, school academic lead, research and impact, at KCL, who will lead group studies of the metabolism and ...
- Source: drugdu
- 129
- March 13, 2024
【EXPERT Q&A】Is there a requirement for the registration address of the second type of medical device business filing?

Drugdu.com expert’s response: There are usually requirements for the registered address when applying for the record-filing of the distribution of Class II medical devices. The registered address is typically required to be a legally operated premises that complies with relevant regulations, ensuring that the storage, sales, and management of medical devices meet the standards. Specific requirements may include the area of the premises, environmental conditions, storage facilities, safety measures, etc.
- Source: drugdu
- 217
- March 12, 2024
First Ever Prototype Applies AI to Colorectal Diagnosis

The incidence and mortality rates of colorectal cancer (CRC) are on an alarming rise, with predictions showing a continuous increase until at least 2040. Currently, CRC ranks as the third most diagnosed (10.7% of all cancer cases) and the second deadliest cancer type. Despite the effectiveness of imaging and endoscopic techniques in CRC detection, the final cancer diagnosis always relies on a pathologist’s assessment of histological samples. Grading dysplasia is still routinely performed by pathologists worldwide when assessing colorectal tissue samples. Computer-aided diagnosis (CAD) systems for colorectal pathology face challenges due to the high data volume and the massive resolution of images, leading to a bottleneck in deep learning (DL) approaches that extract patches from the whole slides. Now, researchers at INESC TEC (Porto, Portugal) and IMP Diagnostics (Porto, Portugal) have created a pioneering prototype that employs artificial intelligence (AI) for colorectal diagnosis. This prototype is a result of a ...
- Source: drugdu
- 147
- March 12, 2024
BIO-THERA’s BAT8010 (ADC-HER2) for injection in combination with BAT1006 (HER2) for injection for the treatment of locally advanced or metastatic solid tumors was approved in clinical trial

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration of the People’s Republic of China (“SDA”), which approves the application for a clinical trial of the investigational drug BAT8010 for injection in combination with BAT1006 for injection for the treatment of locally advanced or metastatic solid tumors. BAT8010 consists of recombinant humanized anti-HER2 antibody and toxin small molecule topoisomerase I inhibitor, connected by self-developed shearable linker.BAT8010 has highly efficient anti-tumor activity, the toxin small molecule has strong cell membrane permeability, and it can be released and kill nearby cancer cells after ADC kills the cancer cells, generating the bystander effect, effectively overcoming the tumor cells’ heterogeneity of tumor cells. Meanwhile, BAT8010 has ...
- Source: drugdu
- 166
- March 10, 2024
Achieving first full year of profitability, and ushering in a new phase of high-quality development

Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended 31 December, 2023 (the “Reporting Period”) and the information currently available to the Board, it is expected that the company will record a profit for the year of no less than RMB500 million for the Reporting Period. This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits for the six months ended 30 June 2023. The full year of profitability is primarily contributed by the continuous growth in sales revenue of the company’s core products HANQUYOU and HANSIZHUANG, as well as cost reduction and efficiency improvement through refined management. Wenjie Zhang, Chairman and Executive Director of Henlius, said: “2023 is a milestone as we reported a full-year profit for the first time. Benefiting from the efficient synergy and ...
- Source: drugdu
- 124
- March 10, 2024
AACR 2024 | Ascentage Pharma to Present Three Preclinical Studies at 2024 American Association of Cancer Research Annual Meeting

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that the latest results from three preclinical studies of the company’s novel drug candidates olverembatinib, MDM2-p53 inhibitor alrizomadlin, FAK/ALK/ROS1 tyrosine kinase inhibitor APG-2449, and EED inhibitor APG-5918, have been selected for presentations at the 2024 American Association of Cancer Research Annual Meeting (AACR 2024). These abstracts are now available on the AACR’s official website. The AACR annual meeting is one of the world’s largest and longest-standing scientific gatherings in the field of cancer research. Covering some of the most cutting-edge advances in all the areas of oncology research and innovation, the annual event attracts tremendous interest from the global cancer research community. This year’s AACR annual meeting will be held from April 5-10 2024, in San Diego, California, USA. These three preclinical abstracts from Ascentage Pharma include: ...
- Source: drugdu
- 96
- March 10, 2024
Chime Biologics Achieves ISO 27001 Certification to Strengthen Information Security in the CDMO Industry

After passing rigorous reviews on all the items of the control standards, Chime Biologics has obtained ISO 27001 certification, which is an internationally recognized standard for information security management. Dr. Jimmy Wei, President of Chime Biologics, said, “We are very proud to achieve ISO 27001 certification. As a global CDMO, Chime Biologics has always emphasized on protecting clients’ data and information and has comprehensive experience in data and information security. It is an important milestone that will further strengthen our global information security standards and our ability to be a trusted global partner.” Chime Biologics has three global ISO certifications, including ISO 14001 Environmental management systems certification, ISO 45001 Occupational health and safety management systems certification and ISO 27001 Information security management systems certification, demonstrating our full commitment in the environment protection, employees’ health and safety, as well as information security. About Chime Biologics Chime Biologics is a leading CDMO ...
- Source: drugdu
- 78
- March 10, 2024

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