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Milestone! Symptoms completely disappeared, dual-antibody treatment of autoimmune diseases published in the New England Journal of Medicine

Targeting B cells and plasma cells is a key strategy for treating a variety of autoimmune diseases. In recent years, chimeric antigen receptor T cell (CAR-T) therapy has made some progress in autoimmune diseases, and many patients who received CD19-targeted CAR-T therapy have achieved long-term drug-free remission. However, the long production process of this type of therapy, the need for patients to undergo pretreatment in advance, and the inability to flexibly adjust the dose of CAR-T cells after the start of treatment have limited its widespread application. In addition, for some patients, their disease may be caused by long-lived plasma cells that express B cell maturation antigen (BCMA) but not CD19. Therefore, even after receiving CD19-targeted CAR-T therapy, autoimmune antibodies such as antinuclear antibodies and polymyositis-scleroderma-associated antibodies (PM-Scl) still exist in patients. In view of the limitations of CAR-T therapy in the application of autoimmune diseases, researchers have set their ...
- Source: drugdu
- 86
- September 16, 2024
After CXO, will the United States start to take action against Chinese APIs?

In response to whether the bill is feasible, the FDA once said, “If there is not enough data to calculate which APIs come from China, what proportion and how much impact, no one can guarantee that there will not be fatal drug shortages, and no one is willing to take such responsibility.” Now, the API industry base survey and assessment initiated by the U.S. Department of Commerce is a comprehensive survey of industry data, which means possible variables in the future. According to reports, in July this year, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce officially announced that it would cooperate with the Strategic Preparedness and Response Administration (ASPR) under the U.S. Department of Health and Human Services (HHS) to conduct a comprehensive investigation and assessment of the U.S. active pharmaceutical ingredients, or API industry base. The survey aims to understand the supply chain ...
- Source: drugdu
- 53
- September 16, 2024
【EXPERT Q&A】How to prepare for AEO certification?

Drugdu.com expert’s response: AEO certification (Authorized Economic Operator) is a system implemented by customs authorities to certify enterprises with good credit standing, compliance, and security management, granting them customs clearance facilitation. Before embarking on the AEO certification process, enterprises need to prepare thoroughly as follows: Ⅰ. Understanding AEO Certification Standards and Requirements Familiarize with Certification Standards: Enterprises should thoroughly read and comprehend the “Customs High-Level Certified Enterprise Standards,” which encompass general standards and specific standards tailored to different types of enterprises, such as importers/exporters of goods and customs brokers. Clarify Application Conditions: Ensure that the enterprise meets the basic conditions for AEO certification, including registration and filing, sound financial status, and lawful operations. Ⅱ. Internal Preparation Comprehensive Review and Self-Assessment: Conduct a comprehensive review of the enterprise’s production and operation, import and export activities, financial data, etc., ensuring their authenticity, accuracy, and completeness. Examine whether the enterprise’s internal control system, ...
- Source: drugdu
- 67
- September 16, 2024
The light of domestic production! Kangnuo’s IL-4R α antibody drug has been approved for market by NMPA

On September 12th, Konya announced that the company’s independently developed Class 1 new drug, Kangyueda ® (Sipuximab Injection) has been officially approved for marketing by the National Medical Products Administration for the treatment of moderate to severe atopic dermatitis in adults. As the first domestic and second globally approved IL-4R alpha antibody drug, Kangyueda ® The launch of Sipuqibai monoclonal antibody not only fills the gap in the field of domestic atopic dermatitis biologics, but also brings new hope for patients with moderate to severe atopic dermatitis to achieve higher treatment goals. Kangyueda ® (Sprucubizumab) Kangyueda ® The Phase III clinical trial of (Sipuximab) is the largest randomized controlled trial of dermatological subjects completed in China to date. The research results show that, The first dose takes effect quickly: Kangyueda ® The first dose of single agent treatment with (Sipuximab) can quickly relieve itching symptoms within one day; After 2 ...
- Source: drugdu
- 92
- September 14, 2024
Obeticolic acid ‘fate judgment’

Since its launch in 2016, Ocaliva (obeticolic acid) has not only failed to successfully develop a new indication for MASH, but also struggled to survive in primary biliary cirrhosis (PBC), and is now facing regulatory scrutiny once again. Recently, the FDA released a pre conference briefing document questioning the effectiveness and safety of Ocaliva for PBC in its approved indications. In this briefing document, the FDA criticized two clinical studies, 747-302 and 747-405. The FDA pointed out that the 747-302 trial failed to demonstrate statistically significant benefits of Ocaliva for PBC, but instead increased the risk of liver transplantation or death in patients. For 747-405, the clinical trial did not meet sufficient and well controlled regulatory standards. Today, members of the FDA Expert Advisory Committee will vote on whether to convert it from accelerated approval to full approval. Out of NASH Ocaliva is a potent and specific agonist of ...
- Source: drugdu
- 78
- September 14, 2024
Johnson&Johnson increases investment in medical imaging

Recently, medical imaging company Spectra has completed its Series B financing and raised $50 million (approximately RMB 356 million) in funding. It is understood that the funds raised in this round of financing will support the commercial expansion and product increase of Spectra ‘Hypervue imaging system to benefit patients with coronary artery disease. It is worth noting that this round of financing is led by Johnson and Johnson Innovation and supported by investors such as S3 Ventures, Lumira Ventures, SV Health Investors, Deerfield Management, NovaVenture, and Heartwork Capital. Spectrawave， The intravascular imaging system has been approved by the FDA According to publicly available information, Spectra was founded in 2017 and is located in Massachusetts, USA. It is a medical imaging company focused on improving the treatment and prognosis of patients with coronary artery disease (CAD). The Spectral Medical Imaging Platform is the most advanced integration of mature imaging technologies, designed ...
- Source: drugdu
- 69
- September 14, 2024
Baird Medical’ successfully went public in the United States

Recently, Baird Medical’s business merger with overseas special purpose acquisition company ExcelFin Acquisition Corp. has been approved by the US SEC, and the F-4 application documents have officially come into effect, with a declaration of registration effectiveness issued. Baird Medicalhas achieved listing on the NASDAQ Stock Exchange in the United States through the merger with ExcelFin Acquisition Corp., a foreign special purpose acquisition company. In addition, Baird Medicalalso announced that ExcelFin has arranged a special shareholders’ meeting to be held on September 26, 2024. After the meeting, it is expected to receive approval from ExcelFin shareholders and the merger will be completed soon. The bumpy road falls on the eve of going public Before going public in the United States, Baird Medicalhad a bumpy road to going public in Hong Kong. Founded in 2012, Baird Medicalis a leading developer and provider of microwave ablation medical devices for minimally invasive treatment ...
- Source: drugdu
- 61
- September 14, 2024
Acquisition of Loss-Making Company to Consolidate Plasma Station Resources

Recently, TianTan Bio (600161.SH) announced that its controlling subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. (referred to as “Chengdu Rongsheng”) intends to acquire 100% of the shares of Wuhan Zhongyuan Ruide Biological Products Co., Ltd. (referred to as “Zhongyuan Ruide”), a wholly-owned subsidiary of CSL Behring Asia Pacific Limited (“CSL Asia Pacific”), for a total amount of $185 million (approximately 1.317 billion yuan). After the completion of this transaction, Zhongyuan Ruide will become a controlled subsidiary of TianTan Bio, and its financial statements will be consolidated. TianTan Bio indicated that it will add a new blood product production enterprise and five operational blood plasma collection stations. According to reporters from China Business Journal, Zhongyuan Ruide was acquired by CSL Asia Pacific between 2017 and 2018 through its subsidiary CSL Behring. However, after seven years, CSL Asia Pacific has chosen to sell at a discounted price. Additionally, the company is currently in ...
- Source: drugdu
- 109
- September 14, 2024
Increasing Investment in R&D Innovation to Deepen Product Competitive Moats

CSPC Pharmaceutical Group has achieved significant milestones in research and development, securing conditional approval for its self-developed Class 1 new drug, Enlansub, and for the injectable version of Rayzoprazole. The company has also received approval for clinical trials in the U.S. for its antibody-drug conjugate, clinical trial approval for its mRNA vaccine against respiratory syncytial virus, and clinical trial approval for the first CAR-T cell injection based on mRNA-LNP technology. As an innovation-driven enterprise and a key player in the national industrial chain, CSPC continues to enhance its R&D investments, elevate its international influence, and fortify its product competitive edge. This year, various in-development drugs have reached key progress points, with some approved for market launch or clinical trials both domestically and internationally. Currently, CSPC is conducting over 130 innovative drug projects, with more than 50 new drugs expected to be launched in the next five years. Comprehensive Market Coverage ...
- Source: drugdu
- 76
- September 14, 2024
Another new COPD drug is coming

On September 6, GlaxoSmithKline (GSK) announced that its Phase 3 MATINEE study of its IL-5 antibody Nucala (mepolizumab) in the treatment of COPD achieved positive results. Compared with the placebo group, the Nucala treatment group achieved a statistically significant reduction in the annualized rate of moderate to severe exacerbations, but specific data have not yet been released. Two months ago, two COPD drugs with new mechanisms: ensifentrine and dupilumab were approved for marketing in the United States and Europe, refreshing the treatment model of this severe respiratory disease. Mepolizumab is expected to join this new round of competition. COPD: The third leading cause of death in humans Chronic obstructive pulmonary disease (COPD), referred to as COPD, is a common, preventable and treatable heterogeneous disease. According to statistics from the World Health Organization, COPD has become the third leading cause of death in humans, with about 11% of people dying from ...
- Source: drugdu
- 68
- September 14, 2024

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