Search Results for “FDA” – Page 107 – media

Jacobio Pharma Announces 2023 Annual Results

Beijing, Shanghai & Boston, Mar. 28, 2024 — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its 2023 annual results. The revenue was RMB63.5 million, the R&D investment was RMB372 million, the cash and cash equivalent at the end of 2023 was RMB 1.2 billion. Jacobio Pharma also announced its recent business progress and expected milestones. Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma, said: “In the past year, Jacobio continued to make progress in our projects. We received approval for registrational phase III clinical trial of the combination therapy between our SHP2 inhibitor JAB-3312 and KRAS G12C inhibitor glecirasib. Our JAB-3312 became the first SHP2 inhibitor to enter into registrational trial. This milestone is consistent with our mission of ‘drugging the undruggable’. Meanwhile, the patient enrollment for pivotal trial of our core product glecirasib has been completed, and the NDA application expected to ...
- Source: drugdu
- 88
- March 30, 2024
Ruike Biologicals and Rongsheng Biologicals Sign Strategic Cooperation Agreement on New Adjuvant Vaccine Project

On March 25th, Jiangsu Ruike Biotechnology Co., Ltd (hereinafter referred to as “Ruike Biotechnology”, stock code: 02179.HK) and Shanghai Rongsheng Biopharmaceutical Co. (hereinafter referred to as “Rongsheng Biopharmaceuticals”) in Shanghai. At the meeting, both parties signed a strategic cooperation agreement on the new adjuvant vaccine project and discussed the details of the project. Adjuvant is an important component in the development of vaccines, and new adjuvants have become the key to the success of innovative vaccine research and development. According to the terms of the agreement, the two parties will jointly carry out the development of new adjuvant vaccines, with Ruike Biologicals providing new adjuvants independently developed based on the new adjuvant technology platform, and Rongsheng Biologicals providing viral antigens independently designed by Rongsheng Biologicals. The project will improve the immunogenicity of existing Rongsheng Bio’s vaccines under development by empowering them with novel adjuvants for the purpose of optimizing immunization ...
- Source: drugdu
- 106
- March 29, 2024
Beijing Municipal Party Secretary Yin Li Met with Novartis Global CEO Wansheim

On the afternoon of March 25, Yin Li, Secretary of the Municipal Party Committee of Beijing, met with Novartis Global CEO Wansheim, Pfizer Chairman and CEO Eberle, and Danaher Global President and CEO Bjørnen. Yin Li introduced the economic and social development of Beijing and the health condition of its residents. He said that the Beijing Municipal Government attaches great importance to residents’ health, vigorously develops health care, gives full play to the advantages of rich scientific and technological talent resources, and continuously improves the level of medical services for the people in the city. Beijing’s pharmaceutical and health industry has a good foundation and a perfect system. In recent years, it has laid out its biopharmaceutical industry in key areas such as cellular genes, nucleic acid drugs, new antibodies, etc., and has formed international leading source innovative varieties in the fields of antibody drugs and immunotherapy drugs. Beijing’s science ...
- Source: drugdu
- 110
- March 29, 2024
【EXPERT Q&A】What is the QSR820 Quality System? What is the relationship with ISO13485?

Drugdu.com expert’s response: The US QSR820 quality system refers to the Quality System Regulation issued by the United States Food and Drug Administration (FDA) for medical devices. This regulation, also known as the Medical Device Quality System Standard, sets forth the quality management system requirements that medical device manufacturers must follow to ensure the safety and effectiveness of medical devices. QSR820 covers various aspects including design controls, production controls, equipment calibration, quality audits, record-keeping, etc. ISO13485 is the medical device quality management system standard published by the International Organization for Standardization (ISO). It bears some similarities to QSR820 as both are quality management system standards for the medical device industry aimed at ensuring product quality and safety. However, ISO13485 is an international standard applicable to medical device manufacturers globally, whereas QSR820 is a regulatory standard mandated by the FDA specifically for medical devices marketed in the United States.
- Source: drugdu
- 155
- March 27, 2024
Clinical Trial of Keytruda and Lynparza Combination Fails to Meet Primary Endpoint for Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer

Don Tracy, Associate Editor Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings. Merck revealed that its Phase III KEYLYNK-006 clinical trial, which tested a combination of Keytruda and Lynparza for the treatment of a subset of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), failed to meet the primary endpoint of improving overall survival (OS) and progression-free survival (PFS). According to the company, its trial compared Keytruda combined with chemotherapy with an additional round of Keytruda plus Lynparza vs. Keytruda with chemotherapy followed by maintenance chemotherapy. However, the safety profiles for both treatments were reported to be consistent with previous findings. Moving forward, Merck said that it plans on continuing to analyze data to share at a later date.1 “As lung cancer continues to be the leading cause of cancer death worldwide, we are committed to exploring Keytruda-based combinations and ...
- Source: drugdu
- 135
- March 26, 2024
Startup Lands $150M for Delicate Dance Between Cancer Cells & Immune Cells

Clasp Therapeutics’ novel T cell engagers could offer advantages over others in this class of cancer immunotherapies. The startup is based on the research of Johns Hopkins University scientist Bert Vogelstein. By FRANK VINLUANCancer immunotherapy comes in several forms, and one area of growing research interest is a type of drug called a T cell engager. These drugs bind to a cancer cell and a T cell simultaneously, bringing both of them together to spark a therapeutic effect. Robert Ross, CEO of Clasp Therapeutics, likens T cell engagers to the chaperone at a middle school dance who grabs a boy and a girl in each hand, getting them to dance together. But in cancer drugs, just as in school dances, sometimes the pairing just isn’t right. The wrong pairing in cancer happens when a drug that’s targeted to a tumor also hits healthy cells, causing toxic effects. Clasp is developing ...
- Source: drugdu
- 85
- March 22, 2024
Henlius’ Trastuzumab Approved in Brazil, a Semi-Exclusive License Area, in Latin America

Recently, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), independently developed and manufactured by Henlius, has been approved to be marketed in Brazil for the treatment of HER2-positive breast cancer and gastric cancer. To date, the product has been approved for marketing in more than 40 countries and regions worldwide. Following the commercialization of HANQUYOU in Argentina, the approval of HANQUYOU in Brazil, the largest economy and the most populous country in Latin America, has become another anchor point for Henlius’ continuous global commercial expansion. Latin America and the Caribbean comprises 33 countries and regions with a total population of close to 660 million as of 2022 and a per capita GDP of close to $10,000 per capita [1]. In Latin America, breast and gastric cancers are the most and fifth most prevalent malignancies, respectively. The total number of new cases of breast and gastric cancer in the region in 2022 ...
- Source: drugdu
- 93
- March 22, 2024
BIO-THERA Signs License and Commercialization Agreement with SteinCares for Two Investigational Biosimilars

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that it has signed license and commercialization agreements with SteinCares for two investigational biosimilars. The Company today announced that it has entered into a license and commercialization agreement with SteinCares for two investigational biosimilars. Under the terms of the agreements, SteinCares will have exclusive distribution and marketing rights for the two biosimilars in Brazil and the rest of Latin America. Under the terms of the agreements, BIO-THERA will be responsible for the development, manufacturing, commercial supply and filing of marketing applications with the U.S. FDA and the European EMA for the two biosimilars, and SteinCares will be responsible for the filing of marketing applications for the two biosimilars in Brazil and the rest of Latin America, and for their commercialization. SteinCares is familiar ...
- Source: drugdu
- 155
- March 21, 2024
AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda

AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug. By FRANK VINLUAN AstraZeneca is bolstering its rare disease pipeline with a deal to buy Amolyt Pharma, a biotech company in late-stage development with a therapy designed to treat a rare hormone deficiency whose only FDA-approved treatment will soon cease production. According to deal terms announced Thursday, AstraZeneca is paying Amolyt shareholders $800 million up front. Another $250 million is tied to the achievement of a regulatory milestone that was not disclosed. Considering that the drug is in Phase 3 testing, that milestone could be a regulatory approval. Lyon, France-based Amolyt is developing a therapy for hypoparathyroidism, a disease in which the parathyroid glands do not produce enough parathyroid hormone. This ...
- Source: drugdu
- 150
- March 18, 2024
First Subject Dosed for Phase 1 Clinical Trial of Henlius’ ADC Candidate HLX42

Shanghai, China, March 14, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the first subject was dosed for a phase 1 clinical trial of HLX42 (NCT06210815), an investigational EGFR-Targeting antibody-drug conjugate (ADC), for the treatment of advanced/metastatic solid tumours. HLX42 was developed by the company based on the collaboration with MediLink Therapeutics and was approved for conducting clinical trial by the National Medical Products Administration (NMPA) and U.S. Food and Drug Administration (FDA). In December 2023, FDA granted Fast Track Designation to HLX42 for the treatment of advanced/metastatic non-small cell lung cancer (NSCLC) patients with disease progression on EGFR targeted therapies. Epidermal growth factor receptor (EGFR) belongs to the receptor tyrosine kinases family and plays an important role in maintaining normal cell functions such as cell proliferation, differentiation and migration. Mutation or overexpression of EGFR is considered to be closely associated with the occurrence of various solid tumours ...
- Source: drugdu
- 83
- March 18, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.