scholarly journals Evolution of the clinical trial landscape in Asia Pacific

2014 ◽  
pp. 75
Author(s):  
Ken J. Lee ◽  
Shourav Yathindranath ◽  
Amar Kureishi ◽  
Simranjit Singh ◽  
Spencer Yeow ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Asia Pacific

scholarly journals Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data

2020 ◽  
Author(s):  
Chak Sing Lau ◽  
Yi-Hsing Chen ◽  
Keith Lim ◽  
Marc de Longueville ◽  
Catherine Arendt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Viral Hepatitis ◽  
Central Europe ◽  
Real World ◽  
Certolizumab Pegol ◽  
Safety Data ◽  
Asia Pacific ◽  
Hbv Reactivation ◽  
Post Marketing

Abstract Introduction/objectives To evaluate the incidence rate (IR) of tuberculosis (TB) and viral hepatitis B and C (HBV/HCV) during certolizumab pegol (CZP) treatment, worldwide and in Asia-Pacific countries, across clinical trials and post-marketing reports (non-interventional studies and real-world practice). Method CZP safety data were pooled across 49 clinical trials from 1998 to June 2017. Post-marketing reports were from initial commercialization until March 2015 (TB)/February 2017 (HBV/HCV). All suspected TB and HBV/HCV cases underwent centralized retrospective review by external experts. Incidence rates (IRs) were calculated per 100 patient-years (PY) of CZP exposure. Results Among 11,317 clinical trial patients (21,695 PY), 62 TB cases were confirmed (IR 0.29/100 PY) including 2 in Japan (0.10/100 PY) and 3 in other Asia-Pacific countries (0.58/100 PY). From > 238,000 PY estimated post-marketing CZP exposure, there were 31 confirmed TB cases (0.01/100 PY): 5 in Japan (0.05/100 PY), 1 in other Asia-Pacific countries (0.03/100 PY). Reported regional TB IRs were highest in eastern Europe (0.17/100 PY), central Europe (0.09/100 PY), and Mexico (0.16/100 PY). Across clinical trials, there was 1 confirmed HBV reactivation and no HCV cases. From > 420,000 PY estimated post-marketing CZP exposure, 5 HBV/HCV cases were confirmed (0.001/100 PY): 2 HCV reactivations; 1 new HCV; plus 2 HBV reactivations in Japan (0.008/100 PY). Conclusions CZP TB risk is aligned with nationwide TB rates, being slightly higher in Asia-Pacific countries excluding Japan. Overall, TB and HBV/HCV risk with CZP treatment is currently relatively low, as risk can be minimized with patient/physician education, screening, and vigilant treatment, according to international guidelines. Key Points:• TB rates were highest in eastern/central Europe, Mexico, and Asia-Pacific regions.• With the implementation of stricter TB screening and risk evaluations in 2007, especially in high TB incidence countries, there was a notable reduction TB occurrence.• Safety profile of biologics in real-world settings complements controlled studies.• TB and hepatitis (HBV/HCV) risk with certolizumab pegol (CZP) treatment is low.

INSIDE INDUSTRY

2013 ◽  
Vol 17 (04) ◽  
pp. 63-71
Keyword(s):  
Clinical Trial ◽  
Systems Biology ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Chief Executive ◽  
Management Team ◽  
Strategic Partnership ◽  
Asia Pacific ◽  
Bacteria Detection ◽  
Medical Technologies

Concert Pharmaceuticals announces completion of enrollment in Phase II CTP-499 clinical trial for the treatment of diabetic kidney disease. NanoLogix bacteria detection plates break longevity records using Anthrax. AngioLight lands strategic partnership with Medical Technologies Innovation Asia. BioScience Managers expands Asia Pacific presence. Simbionix signs an agreement with the Laparoscopic Surgical Skills Foundation. The Institute for Systems Biology and AB SCIEX partner to help make medical care more predictive and personalized. Alchemia appoints Charles Walker as Chief Executive Officer. Anergis expands management team. Novozymes acquires enzyme business from Canadian Iogen Corporation.

INSIDE INDUSTRY

2017 ◽  
Vol 21 (11) ◽  
pp. 32-43
Keyword(s):  
Drug Delivery ◽  
Clinical Trial ◽  
Fragility Fractures ◽  
Asia Pacific ◽  
European Patent ◽  
Medical Cannabis ◽  
The Us ◽  
Long Acting ◽  
Drug Delivery Devices ◽  
Delivery Technology

APAC drug delivery devices market to reach $5.4 billion in 2023. Mergermarket released Global Pharma, Medical & Biotech trend report for Q3 2017. Global BioLife develops breakthrough modified sugar. Breakthrough noodle formula with low-glycemic score of 38. Aphria ships first medical cannabis oil to Australia’s Medlab for clinical trial. Envirotainer doubles e-technology capacity across Asia. Genesis CancerCare Queensland is first in Asia-Pacific to use Elekta’s Venezia Brachytherapy Applicator. iX Biopharma secures European patent for WaferiX drug delivery technology. Shingrix approved in the US for prevention of shingles in adults aged 50 and over. First three-monthly long-acting treatment for schizophrenia patients in Singapore. China, Brazil and Russia named by healthcare companies as riskiest markets for compliance and regulation. New survey shows patients in Asia Pacific fail to recognize their fragility fracture is due to osteoporosis. Healthcare community join forces to fight growing epidemic of fragility fractures caused by osteoporosis.

Taiwan as a Clinical Trial Center of Excellence in the Asia Pacific

2007 ◽  
Vol 11 (12) ◽  
pp. 841-844
Author(s):  
Wing-Kai Chan ◽  
Ding-Shinn Chen
Keyword(s):  
Clinical Trial ◽  
Asia Pacific ◽  
Center Of Excellence

This article shortly illustrates about Taiwan as a clinical trial center of excellence in the Asia Pacific.

INSIDE INDUSTRY

2012 ◽  
Vol 16 (02) ◽  
pp. 44-52
Keyword(s):  
Clinical Trial ◽  
Central Nervous System ◽  
Brain Cancer ◽  
Phase 1 ◽  
Asia Pacific ◽  
Molecular Diagnostic ◽  
Cns Disorders ◽  
Phase 1 Clinical Trial ◽  
Diagnostic Assays ◽  
Otsuka Pharmaceutical

Circadian Commences First Phase 1 Clinical Trial of VEGF-C Antibody VGX-100 in Cancer Patients. Life Technologies Partners With DaAn Gene to Develop and Commercialize Molecular Diagnostic Assays in China. Brain Cancer Patient Receives First TrueBeam STx Treatment in Asia at BGS Global Hospitals in Bangalore. Lancaster Laboratories and BioAzure Enter Partnership. NovAliX Enters into Multi-Target Integrated Drug Discovery Collaboration with Teijin Pharma. Otsuka Pharmaceutical and UCB Focus Collaboration in the Area of Central Nervous System (CNS) Disorders. BIOTRONIK Opens New Asia Pacific Headquarters in Singapore. A*STAR, GE Global Research Join Forces to Develop Integrated Advanced Medical Imaging Technologies for Improved Clinical Diagnosis. Alpha to Build $50m Plant in Thailand.

scholarly journals The Safety of Dengvaxia and Should Hospitalization be an Outcome for its Clinical Trial?

2018 ◽  
Vol 1 (1) ◽  
pp. 01-02
Author(s):  
Godofreda Dalmacion
Keyword(s):  
Clinical Trial ◽  
The Philippines ◽  
Asia Pacific ◽  
Efficacy Rate ◽  
Pacific Region ◽  
Efficacy And Safety ◽  
Asia Pacific Region ◽  
Efficacy Trial ◽  
Mass Immunization

The uncertainties on the efficacy and safety of Dengvaxia continue to haunt doctors, parents, and lawmakers alike in the Philippines. After the mass immunization of about 850,000 children with Dengvaxia, there has been a continuing report of deaths, unofficially 29 to date among those who received the vaccine between 2016-2017. Countries in the Asia Pacific region, including the Philippines, were one of the sites for the Dengvaxia Clinical Trial. In 2014, the Efficacy Trial of Dengvaxia covering the period after completion of the 3 doses up to the 28th day was published by Capeding, et al. An overall efficacy rate of 56.5% was reported but it can be misleading since the efficacy rates for each serotype varied widely. The uncertainties on the efficacy and safety of Dengvaxia continue to haunt doctors, parents, and lawmakers alike in the Philippines. After the mass immunization of about 850,000 children with Dengvaxia, there has been a continuing report of deaths, unofficially 29 to date among those who received the vaccine between 2016-2017. Countries in the Asia Pacific region, including the Philippines, were one of the sites for the Dengvaxia Clinical Trial. In 2014, the Efficacy Trial of Dengvaxia covering the period after completion of the 3 doses up to the 28th day was published by Capeding, et al. An overall efficacy rate of 56.5% was reported but it can be misleading since the efficacy rates for each serotype varied widely. The uncertainties on the efficacy and safety of Dengvaxia continue to haunt doctors, parents, and lawmakers alike in the Philippines. After the mass immunization of about 850,000 children with Dengvaxia, there has been a continuing report of deaths, unofficially 29 to date among those who received the vaccine between 2016-2017. Countries in the Asia Pacific region, including the Philippines, were one of the sites for the Dengvaxia Clinical Trial. In 2014, the Efficacy Trial of Dengvaxia covering the period after completion of the 3 doses up to the 28th day was published by Capeding, et al. An overall efficacy rate of 56.5% was reported but it can be misleading since the efficacy rates for each serotype varied widely.

scholarly journals Correction to: Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data

2020 ◽  
Vol 39 (10) ◽  
pp. 3161-3161
Author(s):  
Chak Sing Lau ◽  
Yi-Hsing Chen ◽  
Keith Lim ◽  
Marc de Longueville ◽  
Catherine Arendt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Viral Hepatitis ◽  
Real World ◽  
Certolizumab Pegol ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Asia Pacific
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