Latest news with #hepatitisB
Mint
3 days ago
- Health
- Mint
India to introduce more advanced testing for imported blood products to reduce infection risk
New Delhi: The health ministry plans to mandate the use of a faster and more accurate method to test all imported blood products to maintain the highest safety standards and reduce the risk of infection from transfusions. The ministry intends to introduce nucleic acid testing (NAT) to improve the screening of imported blood products for antibodies of the human immunodeficiency virus (HIV), the hepatitis B virus, the hepatitis C virus and other impurities, an official aware of the matter said. The decision to shift to NAT has already been taken by the regulator, the Drug Controller General of India (DCGI), and the matter was discussed at the Drugs Technical Advisory Board meeting in April. The board is the highest statutory body responsible for advising the Central and state governments on technical matters related to the administration of the Drugs and Cosmetics Act, 1940. Also Read | Banking on blood: Health ministry frames guidelines to curb paid donations, improve efficacy of transfusions With the introduction of NAT, the conventional testing method known as ELISA, or enzyme-linked immunosorbent assay, will be done away with. ELISA, while a powerful tool, has several drawbacks, including the potential for false positive and negative results, apart from being time-consuming. The Department of Pharmaceuticals and the National Institute of Biologicals (NIB) in Noida had issued an alert in October after the NIB found three imported blood products—Berirab-P (used in rabies injections), Hepabig (to prevent hepatitis B virus infection) and Tetglob (used for tetanus treatment)—to be of sub-standard quality. When the Berirab-P and Hepabig samples were tested again at the National Institute of Virology in Pune using an advanced version of polymerase chain reaction, which is more sensitive than ELISA, they passed the test metrics. The set of Tetglob samples sent to a private laboratory that used ELISA were non-reactive. Safety standards Bharat Serums and Vaccines Ltd, now owned by Mankind Pharma, is the only company in the country that imports these lifesaving blood products. Imported blood products are used for the treatment of critically ill patients or those who are suffering thalassemia and other blood-related disorders. These products are tested at government laboratories to ensure they meet safety and quality standards. Also Read | India plans standard evaluation and quality protocols for HMPV' testing kits 'These are tested using conventional methods, but now the plan is to amend the rules to allow an advanced version of testing in line with international practices," the official said. 'NIB also proposed that an amendment may be considered to test blood products by NAT." Queries sent to the health ministry, the Department of Pharmaceuticals and the Mankind Pharma spokesperson remained unanswered till press time. 'NAT testing gives accurate and quick results and nowadays it is highly used. NAT testing is used for tuberculosis and NAT testing was modified during the covid-19 pandemic to detect the coronavirus," a scientist from the Indian Council of Medical Research said, requesting anonymity. 'The ELISA test may sometimes give false results if the viral load in the sample is low. However, PCR and NAT give accurate results even if the viral load is low." Also Read | ICMR and CDSCO develop framework for validation of pathogen identification and antimicrobial susceptibility testing According to an assessment by the National Blood Transfusion Council, the apex policymaking body for issues pertaining to blood and plasma, the clinical requirement of blood in the country is about 14.5 million units per year. The volume of each unit of blood is about 450 ml. In India, the import, manufacture, distribution and sale of drugs, cosmetics and notified medical devices are regulated by the Drugs and Cosmetics Act and the Drugs and Cosmetics Rules, 1945.
Business Wire
6 days ago
- Business
- Business Wire
Drug Farm and Xiamen Amoytop Biotech Co., Ltd. Enter into Option Agreement for First-In-Class Innate Immunity Agonist, DF-006 to Treat Hepatitis B and Hepatocellular Cancer
SHANGHAI, China & XIAMEN, China & ALBANY, N.Y.--(BUSINESS WIRE)-- Drug Farm, a private biotechnology company utilizing genetics and artificial intelligence technologies to discover and develop innovative, immune-modulating therapies, today announced that it has entered into an option agreement with Amoytop. The two parties will engage in clinical collaboration with Drug Farm's first-in-class ALPK1 agonist, DF-006 in the field of hepatitis B and hepatocellular cancer in the Greater China region (Mainland China, Taiwan region, Hong Kong, and Macau). DF-006 is an orally administered ALPK1 agonist immunomodulator that potently stimulates local, innate immunity in the liver 1. DF-006 has successfully completed single and multiple ascending dose (MAD) evaluation in healthy volunteers, and MAD evaluation in virologically suppressed HBeAg negative chronic hepatitis B (CHB) patients where encouraging anti-HBV activity was observed 2. Dr. Tony, Xu, COO, Drug Farm, said:"DF-006 has a novel mechanism of action that is uniquely able to stimulate innate immunity in the liver to fight hepatitis B infection and hepatocellular cancer. In preclinical studies, DF-006 has shown enhanced efficacy against hepatitis B when combined with interferon-alpha. We look forward to assessing the clinical combination of DF-006 and Amoytop's approved drug, PEGBING ® as a potential new therapeutic regimen that may improve functional cure in hepatitis B patients.' Mr. Sun Li, Chairman and Chief Executive Officer of Amoytop, said: "Amoytop is dedicated to becoming the leading company developing a functional cure for CHB. PEGBING ® -based therapy has already demonstrated significant enhancement of functional cure rates across diverse HBV-infected populations. Through investigational research of a novel, innovative drug DF-006, we offer the potential for sustained functional cure with significant reduction of risk for hepatocellular cancer.' About Drug Farm Drug Farm is a private biotechnology Company developing innovative treatments targeting innate immunity for hepatitis B, heart and kidney diseases, and ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome. Drug Farm's unique IDInVivo platform combines breakthrough technologies in genetics and AI to discover new treatments. IDInVivo technology allows the direct assessment of gene targets in living animals with intact immune systems. Using the IDInVivo platform, Drug Farm has identified novel innate immunity pathways and targets and is now rapidly advancing multiple first-in-class drug candidates into clinical development. For more information please visit: Reference: Gane, EJ, et al. Journal of Hepatology, Vol. 80, Supplement 1, S87, LBP-020, June 2024 About Xiamen Amoytop Biotech Co., Ltd. Xiamen Amoytop Biotech Co., Ltd. is an innovative biopharmaceutical company and a listed company on the Science and Technology Innovation Board (SSE STAR Market) in China, specializing in R&D, manufacturing and marketing of regular and long-acting recombinant protein drugs. Focusing on the R&D of immune-related cytokine medicines, Amoytop is committed to becoming a leader in solving cytokine medicine-based systemic immune problems, providing better solutions for major diseases (such as viral hepatitis, malignant tumors) and immunotherapy.
Yahoo
6 days ago
- Business
- Yahoo
Drug Farm and Xiamen Amoytop Biotech Co., Ltd. Enter into Option Agreement for First-In-Class Innate Immunity Agonist, DF-006 to Treat Hepatitis B and Hepatocellular Cancer
Drug Farm enters into clinical collaboration with Amoytop SHANGHAI, China & XIAMEN, China & ALBANY, N.Y., May 27, 2025--(BUSINESS WIRE)--Drug Farm, a private biotechnology company utilizing genetics and artificial intelligence technologies to discover and develop innovative, immune-modulating therapies, today announced that it has entered into an option agreement with Amoytop. The two parties will engage in clinical collaboration with Drug Farm's first-in-class ALPK1 agonist, DF-006 in the field of hepatitis B and hepatocellular cancer in the Greater China region (Mainland China, Taiwan region, Hong Kong, and Macau). DF-006 is an orally administered ALPK1 agonist immunomodulator that potently stimulates local, innate immunity in the liver1. DF-006 has successfully completed single and multiple ascending dose (MAD) evaluation in healthy volunteers, and MAD evaluation in virologically suppressed HBeAg negative chronic hepatitis B (CHB) patients where encouraging anti-HBV activity was observed2. Dr. Tony, Xu, COO, Drug Farm, said: "DF-006 has a novel mechanism of action that is uniquely able to stimulate innate immunity in the liver to fight hepatitis B infection and hepatocellular cancer. In preclinical studies, DF-006 has shown enhanced efficacy against hepatitis B when combined with interferon-alpha. We look forward to assessing the clinical combination of DF-006 and Amoytop's approved drug, PEGBING® as a potential new therapeutic regimen that may improve functional cure in hepatitis B patients." Mr. Sun Li, Chairman and Chief Executive Officer of Amoytop, said: "Amoytop is dedicated to becoming the leading company developing a functional cure for CHB. PEGBING®-based therapy has already demonstrated significant enhancement of functional cure rates across diverse HBV-infected populations. Through investigational research of a novel, innovative drug DF-006, we offer the potential for sustained functional cure with significant reduction of risk for hepatocellular cancer." About Drug Farm Drug Farm is a private biotechnology Company developing innovative treatments targeting innate immunity for hepatitis B, heart and kidney diseases, and ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome. Drug Farm's unique IDInVivo platform combines breakthrough technologies in genetics and AI to discover new treatments. IDInVivo technology allows the direct assessment of gene targets in living animals with intact immune systems. Using the IDInVivo platform, Drug Farm has identified novel innate immunity pathways and targets and is now rapidly advancing multiple first-in-class drug candidates into clinical development. For more information please visit: Reference: Xu C, et al. Hepatology. 2023 Jan 1;77(1):275-289. doi: 10.1002/hep.32614. Epub 2022 Sep 17. Gane, EJ, et al. Journal of Hepatology, Vol. 80, Supplement 1, S87, LBP-020, June 2024 About Xiamen Amoytop Biotech Co., Ltd. Xiamen Amoytop Biotech Co., Ltd. is an innovative biopharmaceutical company and a listed company on the Science and Technology Innovation Board (SSE STAR Market) in China, specializing in R&D, manufacturing and marketing of regular and long-acting recombinant protein drugs. Focusing on the R&D of immune-related cytokine medicines, Amoytop is committed to becoming a leader in solving cytokine medicine-based systemic immune problems, providing better solutions for major diseases (such as viral hepatitis, malignant tumors) and immunotherapy. View source version on Contacts United States:Henri Lichenstein, Executive OfficerEmail: hlichens@ China:Tony Xu, and Chief Operating OfficerEmail: amoytop@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
New Straits Times
7 days ago
- Health
- New Straits Times
Expert: Fomema gaps let syndicates slip through
KUALA LUMPUR: A security expert has called on the government to tighten oversight of the Foreign Workers' Medical Examination Monitoring Agency (Fomema), citing weak inter-agency coordination and poor system checks that have left the agency vulnerable to exploitation by criminal syndicates. Universiti Pertahanan Nasional Malaysia's (UPNM) Faculty of Defence Studies and Management Professor Dr Mohd Mizan Aslam said the current Fomema system lacked a comprehensive verification process, making it susceptible to identity fraud and document forgery. "Although the system is centralised, the database and monitoring mechanisms are not thorough. This opens the door for syndicates to manipulate data and forge health certificates," he told the New Straits Times. He said Fomema currently processed medical certifications based solely on submitted documents, without verifying whether foreign workers had criminal records, previous deportations, or were using false identities. "This loophole has serious implications. Without accurate identity verification — via biometrics or inter-agency checks — syndicates will continue to exploit the system," he added. Mizan comments come in the wake of a recent crackdown by the Immigration Department on a forgery syndicate capable of producing up to 100 fake passports daily. The syndicate, which charged between RM100 and RM150 per fake passport, also manipulated the biodata of undocumented migrants to obtain Fomema health clearances. These forged medical documents were sold for between RM600 and RM1,000 each. He said this exposed clear weaknesses in the system, adding that syndicates were not just bypassing immigration rules, but also public health safeguards. "This situation could lead to the return of diseases like tuberculosis and hepatitis B, especially as infected individuals from countries with weaker healthcare systems go undetected," he said. "Malaysia has successfully controlled these diseases through vaccination and health campaigns. But without effective screening, they could resurface and strain our health infrastructure." Mizan said that while international passport systems were generally secure, Fomema documents lacked similar safeguards. "Unlike passports, Fomema certificates do not have tamper-proof features like QR codes or digital watermarks. This makes them easier to forge and abuse," he said. To address the issue, Mizan urged the government to introduce biometric verification for all foreign worker medical screenings, strengthen access control to Fomema's database, and integrate its system with immigration and law enforcement agencies. He also proposed placing certified integrity officers at key government departments to monitor compliance and prevent internal collusion. While acknowledging growing concerns over the agency's integrity, Mizan stressed that Fomema should not be dismantled but reformed. "We shouldn't abandon Fomema. We need to upgrade its technology, tighten control mechanisms, and improve coordination across agencies so it can fulfil its role in safeguarding national interests," he said.
Yahoo
23-05-2025
- Business
- Yahoo
ISS backs Dynavax directors in board fight with Deep Track Capital
By Svea Herbst-Bayliss NEW YORK (Reuters) -Proxy advisory firm Institutional Shareholder Services urged Dynavax Technologies shareholders on Friday to reelect all its company directors instead of backing life sciences investment firm Deep Track Capital's four nominees. "Vote for all four management nominees," ISS wrote in a note to clients that was seen by Reuters. "The dissident has failed to present a compelling case that change is necessary at this meeting." Investors will vote on June 11. Recommendations from ISS and its rivals Glass Lewis and Egan-Jones often help guide shareholders' decisions. Deep Track Capital is pushing on with a proxy fight and wants new directors to prioritize development of the company's hepatitis B vaccine instead of pursuing new acquisitions. The investment firm is Dynavax's second largest shareholder with a nearly 15% stake. It wants Dynavax to focus exclusively on growing Heplisav, a vaccine designed to prevent the hepatitis B infection that can lead to chronic liver disease and death, into an asset that a large pharma company would want to own. While ISS recommended against Deep Track's nominees, it acknowledged certain challenges. "There has been a stall in momentum," it said in a report, but noted that "the market has in no way rebuked the company's strategy." Dynavax's stock price has fallen 18% over the last 12 months. Representatives for Dynavax and Deep Track did not immediately respond to requests for comment. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
