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SINOVAC initiates Phase I clinical study for SINOVAC’s hexavalent reassortant rotavirus vaccine

On March 27, 2024, the oral hexavalent reassortant rotavirus live attenuated rotavirus vaccine (Vero cell), jointly developed by SINOVAC’s Beijing Kexing Zhongwei Biotech Co. and Kexing (Dalian) Vaccine Technology Co. SINOVAC’s hexavalent reassortant rotavirus vaccine was approved for entry into the clinic in January 2024. This study is intended to be a single-arm, open design in adults and children, and a randomized, double-blind, placebo-controlled design in infants, to assess the safety and tolerability of the vaccine in adult and pediatric populations, as well as the immunogenicity of the vaccine in healthy infants. Rotavirus (RV) is a virus of the family Eutheroviridae, whose primary mode of transmission is fecal-oral, with the possibility of respiratory transmission also present, and which primarily infects the epithelial cells of the small intestine, thereby causing cellular damage and diarrhea. Rotavirus gastroenteritis (RVGE) is the leading cause of severe, fatal diarrhea in children under 5 years of ...
- Source: drugdu
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- March 30, 2024
Minhai Biotech Signs Strategic Cooperation Memorandum with Daxing District Government and AstraZeneca

On March 25th, Daxing District Government, AstraZeneca, Minhai Biological and other companies signed a strategic cooperation memorandum in Daxing, Beijing, to jointly explore the mode of cooperation in the field of vaccines, and help China’s vaccine innovation products to cooperate and develop at home and abroad. Daxing District’s life and health industry ecosystem has been continuously improved, creating a favorable business environment that attracts foreign investment and strengthens the confidence of global outstanding enterprises in long-term development in Beijing. The strategic cooperation between AstraZeneca and Minhai Biotechnology will further expand the circle of friends and influence of Daxing District’s world-class vaccine industry cluster, and will become a substantive measure for Daxing District to implement the “Action Plan for Attracting and Utilizing Foreign Investments with Greater Efforts by Solidly Pushing Forward the Opening Up of the Country to the Outside World at a High Level”. This time in Beijing Daxing to ...
- Source: drugdu
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- March 30, 2024
Veeda Clinical Research acquires Heads, a European CRO

Veeda Clinical Research has acquired Heads, a privately held European CRO, which specialises in conducting clinical trials in oncology. Established in 2010, Heads has operational presence in 25 multiple strategically important locations across Europe, North America and Asia Pacific region. Veeda expands its reach to major geographies and adds capabilities of late-sta. ge clinical trial execution with strong focus on oncology with this acqusition The acquisition provides Heads a strong operational platform and an opportunity to expand its expertise and capabilities to the Indian and South-East Asian markets. With this acquisition, Veeda’s global pharma and biotech clients can now avail early to late-phase CRO services across Europe, US, and Asia Pacific. During the integration phase, Heads will continue to offer uninterrupted support to client programs. https://www.vspharma.in/veeda-clinical-research-acquires-heads-a-european-cro/
- Source: drugdu
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- March 30, 2024
ICRA

ICRA expects the revenues of its sample set of 25 Indian pharma companies (which account for ~60 per cent of the overall Indian pharma industry) to grow by 8-10 per cent in FY2025, post a YoY increase of 13-14 per cent in FY2024. Following the high base of FY2024, the revenue growth momentum from the US and Europe markets is expected to moderate to 8-10 per cent and 7-9 per cent, respectively, from the YoY expansion of 18-20 per cent and 16-18 per cent, respectively, estimated for FY2024. The domestic market is expected to see stable growth at 6-8 per cent, while the emerging markets may log in an 8-10 per cent rise in FY2025, against 16-18 per cent in FY2024. The revenue growth of the sample set companies in the US market in FY2024 has been supported by increased new product launches, product shortages in select therapeutic segments, and ...
- Source: drugdu
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- March 30, 2024
【EXPERT Q&A】What is the content of the MDR technical document that EU CE needs to submit for medical device registration?

Drugdu.com expert’s response: The MDR technical documentation required for medical device registration in the European Union typically includes the following components: 1.General Information: Basic product information, manufacturer details, product classification, and product description. 2.Design and Manufacturing Information: Details about the product’s design process, manufacturing process, material selection, assembly process, etc. 3.Performance and Functionality: Expected use of the product, performance indicators, technical specifications, functional descriptions, etc. 4.Risk Analysis: Analysis and assessment of potential risks associated with the product, including descriptions of control measures and risk management plans. 5.Clinical Evaluation: Clinical trial data and assessment results for the product, including trial design, results, safety, and efficacy data. 6.Summary of Technical Documentation: Comprehensive summary and explanation of the above content to ensure the integrity and consistency of the documentation. Additionally, depending on the specific characteristics and classification of the product, other relevant information and documents may be required to ensure compliance with the ...
- Source: drugdu
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- March 30, 2024
CPhI North America 2024

Organiser: Informa Markets Time:7 – 9 May 2024 address：1101 Arch Street Philadelphia, PA 19107, Philadelphia PA United States Exhibition hall: Pennsylvania Convention Center Product range: Apis: vitamins, hormones, sulfonamides, antipyretic analgesics, tetracycline, amino acids and their derivatives, chloramphenicol, digestive system drugs, other anti-infective drugs, penicillins, aminoglycosides, lincomycin, cardiovascular system drugs, anti-parasitic diseases drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western drugs Ingredients Packaging equipment: pharmaceutical machinery, packaging machinery, packaging materials, pharmaceutical production equipment and technology, pharmaceutical packaging equipment, pharmaceutical packaging materials, pharmaceutical production, cleaning, disinfection configuration and laboratory instrument system Pharmaceutical products: various proprietary Chinese medicines, Western medicines, new drugs, various raw materials, chemical pharmaceuticals, pharmaceutical intermediates, biopharmaceuticals, traditional medicines, Chinese medicine, herbs, animal and plant extracts, veterinary drugs, food ingredients and additives, etc About CPhI North America： CPhI North America is the largest and most authoritative pharmaceutical raw materials exhibition in the United States. The World Pharmaceutical ...
- Source: drugdu
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- March 29, 2024
FDA Approves Roche’s Cobas Malaria Test, Designed to Screen for Malaria in Potential Blood Donors

Don Tracy, Associate Editor Action marks the first FDA-approved blood screening test for malaria. Roche announced that the FDA has officially approved the Cobas Malaria test, focused on inspecting blood donors for malaria, aiming to enhance the safety of blood supply. The test, which screens blood samples for five species of Plasmodium parasites, is the first of its kind approved for this purpose and aims to reduce the risk of malaria transmission through transfusions. Roche stated that it expects the test to be available in the United States at some point during the second quarter of this year.1 “As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood,” said Matt Sause, CEO, Roche Diagnostics, in a press release. “The approval of cobas Malaria represents a significant advancement in malaria detection, offering healthcare professionals a reliable tool for ...
- Source: drugdu
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- March 29, 2024
Novo Nordisk Acquires Cardior Pharmaceuticals for $1.112B in Effort to Bolster Cardiovascular Disease Pipeline

Don Tracy, Associate Editor Deal includes the novel treatment CDR132L, which is currently in Phase II clinical trials for heart failure. Novo Nordisk announced that it has acquired Cardior Pharmaceuticals in hopes of improving its pipeline in cardiovascular disease management. The acquisition includes Cardior’s top drug candidate, CDR132L, which is currently in Phase II of clinical development for treating heart failure. Under terms of the agreement, Cardor has the potential to earn up to $1.112 billion, including an upfront payment and the opportunity for more payments pending the completion of certain development and commercial milestones.1 “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programs across all phases of clinical development,” said Martin Holst Lange, EVP, development, Novo Nordisk, in a press release. “We have been impressed by the scientific work carried out by the ...
- Source: drugdu
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- March 29, 2024
Blood Analysis Predicts Sepsis and Organ Failure in Children

Sepsis poses a grave risk in which a severe immune reaction to infection leads to organ damage. Identifying sepsis in children is complex since the symptoms mirror those of many pediatric illnesses. Presently, if sepsis is suspected, medical practitioners administer antibiotics, increase fluids, and intensify monitoring for the child, leading to some receiving unneeded treatments. Now, a new technique developed by researchers can predict the likelihood of a child developing sepsis and succumbing to organ failure. The research by investigators at the University of Queensland (Brisbane, Australia) involved more than 900 critically ill children in the emergency departments and intensive care units across four hospitals. Blood samples collected during the acute stage of their infection were examined for gene activation or suppression. This analysis allowed the researchers to identify gene expression patterns that could predict the child’s risk of organ failure within the next 24 hours, as well as whether ...
- Source: drugdu
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- March 29, 2024
Simple Skin Biopsy Test Detects Parkinson’s and Related Neurodegenerative Diseases

Parkinson’s disease and a group of related neurodegenerative disorders known as synucleinopathies impact millions globally. These conditions, including Parkinson’s disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and pure autonomic failure (PAF), are progressive neurodegenerative diseases that, despite having some similar symptoms like tremors and cognitive issues, vary in their outcomes and do not benefit from identical treatments. A common feature among them is the accumulation of an abnormal protein in nerve fibers within the skin, known as phosphorylated α-synuclein (P-SYN). Now, neurologists have developed a simple skin biopsy test that can detect this abnormal form of alpha-synuclein with high positivity rates in individuals with such disorders. In the study, neurologists at Beth Israel Deaconess Medical Center (BIDMC, Boston, MA, USA) enrolled 428 people, ages 40-99 years who were either diagnosed with one of the synucleinopathies based on clinical evaluations confirmed by specialists or were healthy volunteers ...
- Source: drugdu
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- March 29, 2024

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