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New smartphone-based method for high-quality gait analysis

Researchers at Kennedy Krieger Institute and Johns Hopkins Medicine have developed a new, accessible approach to analyze a patient’s walking ability and stances more effectively. Following numerous tests, they determined that a simple video recorded on a personal pocket device, such as a smartphone or tablet, can be used to measure gait at a clinical, high-quality level. Experts say current state-of-the-art approaches to gait analysis are often expensive and inaccessible due to time constraints and extensive efforts required for assessments. However, there is a significant need for this analysis in patients experiencing conditions such as traumatic brain injury, physical injury, or disorders. Through freely available software they created, walking abilities can now be assessed more conveniently, enhancing the comprehensiveness of rehabilitation. Dr. Ryan Roemmich, a research scientist at the Kennedy Krieger Institute, assistant professor of physical medicine and rehabilitation at the Johns Hopkins University School of Medicine, and co-principal investigator ...
- Source: drugdu
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- March 30, 2024
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
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- March 30, 2024
The latest data of Akesobio’s “PD-1/VEGF dual antibody” Ivonescimab combined with chemotherapy for first-line treatment of NSCLC are announced

At the high-profile European Lung Cancer Conference (ELCC) 2024, Akesobio and its partner Summit Therapeutics (Summit) jointly released the PD-1/VEGF dual antibody Ivonescimab(AK112/SMT112) combined with chemotherapy for the first-line treatment of advanced non-cancer lung cancer. Updated data from Cohort 1 (EGFR/ALK wild type) of the Phase II small cell lung cancer (NSCLC) clinical study (AK112-201). Previous research results have been published at the 2023 ASCO Annual Meeting and eClinical Medicine, a subsidiary of the top international medical journal “The Lancet”. Cohort 1 included a total of 135 patients with EGFR/ALK wild-type NSCLC who received Ivonescimab combined with chemotherapy, including 63 patients with squamous cell carcinoma and 72 patients with non-squamous cell carcinoma. As of October 2023, the median follow-up time has been further extended to 21.3 months. As the follow-up time is extended, the clinical advantages of Ivosib in the first-line treatment of advanced or metastatic NSCLC become more obvious. ...
- Source: drugdu
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- March 30, 2024
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
- 185
- 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

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