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Antibody therapy receives FDA approval again

biopharmaceutical era Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. On September 11th, Johnson&Johnson announced that the US FDA has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. According to the press release, Tremfya is the first dual acting mechanism interleukin-23 (IL-23) inhibitor approved for the treatment of active ulcerative colitis. In the critical QUASAR project, the drug demonstrated a highly statistically significant endoscopic response rate. The approval of Tremfya this time is supported by data from the ongoing Phase 2b/3 QUASAR study, which evaluates the efficacy and safety of Tremfya in adult patients with moderate to severe ...
- Source: drugdu
- 62
- September 16, 2024
WHO chief hails ‘massive success’ of polio campaign amid tragic reality

WHO chief Tedros Adhanom Ghebreyesus tweeted that it had been “a massive success amidst a tragic daily reality of life” for more than two million Gazans who have been caught up in the intense fighting since last October’s terror attacks by Hamas unleashed the war in Gaza. In three phases over twelve days, from 1 to 12 September, UN agencies and partners provided novel oral polio vaccine type 2 (nOPV2) to some 558,963 children, reaching families living in shelters, tents and camps for the displaced. Tweet URL Richard Peeperkorn, WHO Representative for the occupied Palestinian territory applauded the “incredible resilience” of health and community workers in conducting the campaign “at an unprecedented scale and speed under the toughest conditions” in the war-battered enclave. “Swift action by the Global Polio Eradication Initiative – from the moment the virus was detected to the launch of the vaccination campaign – speaks to the ...
- Source: drugdu
- 66
- September 16, 2024
WHO approves first mpox vaccine to boost access in Africa

The MVA-BN vaccine from the Danish pharmaceutical company Bavarian Nordic was prequalified by the WHO on Friday and has already been approved in Europe and the United States, for use by adults. WHO approval will accelerate access for millions, to reduce transmission and help contain the outbreak. WHO’s Director-General, Tedros Adhanom Ghebreyesus said the prequalification of this vaccine is an important step in the fight against the mpox virus in Africa and for the future. “We now need urgent scale up in procurement, donations and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives,” Mr. Ghebreyesus said. The MVA-BN vaccine can be given in two doses to people 18 years and older, four weeks apart, which has an estimated 82 per cent effectiveness. For infants, young children, pregnant women and immunocompromised people, the vaccine ...
- Source: drugdu
- 80
- September 16, 2024
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
- 84
- 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
- 52
- 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
- 66
- 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
- 86
- 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
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- 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
- 62
- 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
- 58
- September 14, 2024

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