HOME ABOUT CONTACT AVAILABLE ISSUES SUBSCRIBE MEDIA & ADS CONFERENCE CALENDAR
LATEST UPDATES » Volume 20, No. 9, September 2016 – Infectious Diseases       » Curcumin Derivatives May Prevent Alzheimer's Disease by Promoting Amyloid- Clearance       » Varian Chosen to Equip First Government Owned Proton Centre in China       » Medtronic and SingHealth Collaborate on a Centre of Excellence to Fight Diabetes       » NCCS Awards Contract for Proton Beam Therapy System to Hitachi Asia      
EYE ON CHINA
TaiGen Biotechnology receives Qualified Infectious Disease Product and Fast Track designations from the U.S. FDA

The U.S. Food and Drug Administration (FDA) has granted TaiGen Biotechnology Company, Limited (TaiGen) Qualified Infectious Disease Product (QIDP) and Fast Track designations for community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infections (ABSSSI) for nemonoxacin (Taigexyn®)

These two designations should enable TaiGen to benefit from certain incentives for the development of nemonoxacin as a new antibiotic, including an additional five year extension to new chemical entity (NCE) market exclusivity, priority review, and fast track status provided under the Generating Antibiotic Incentives Now (GAIN) act. GAIN was included in the FDA Safety and Innovation Act (FDASIA) that was signed into law by US President Obama in 2012.

Nemonoxacin is a NCE, broad spectrum antibiotic available in both oral and intravenous formulations. TaiGen have completed a multi-center Phase 3 of the oral formulation in CAP in Taiwan and mainland China and submitted NDA to regulatory authorities in both countries earlier this year. The clinical development of the intravenous formulation in CAP is ongoing inTaiwan and mainland China with Phase 2 completed and initiation of Phase 3 plan for 1Q, 2014. In the US, TaiGen have completed two Phase 2 clinical studies, one in CAP and the other in diabetic foot infections (DFI) with demonstrated efficacy and safety. In the clinical trials conducted to this point, nemonoxacin have shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistantStreptococcus pneumoniae.

Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen said "The recognition of nemonoxacin for QIDP and Fast Track designations highlights the need of new antibiotics in the treatment of life-threatening bacterial infections and the value of nemonoxacin to treat CAP, which is one of the most common respiratory infections that can lead to hospitalization. In addition, we have seen efficacy and high tissue penetration in the Phase 2a DFI trial. Taken together, nemonoxacin is well positioned to treat ABSSSI."

Click here for the complete issue.

NEWS CRUNCH  
news Enterprise meets technology: More than 300 enabling innovations showcased at TechInnovation
news CPhI's Pre-Connect Congress outlines current trends in pharma
news World Population Day 2016
PR NEWSWIRE  
Asia Pacific Biotech News
EDITORS' CHOICE  

Lady Ganga: Nilza'S Story
COLUMNS  
Subscribe to APBN E-Newsletter
Find us under 'Others' option to receive APBN e-newsletters thrice a month!

APBN Editorial Calendar 2016
January:
Guest Editorial - Biotechnology In Korea
February:
Guest Editorial - Biomedical Research Governance
March:
Guest Editorial - Life-Saving Opportunities: A Guide to Regenerative Medicine
April:
Leading-Edge ONCOLOGY
May:
Healthcare Systems & Policies in Asia
June:
Medical Devices & Healthcare Technology
July:
Water Technology and Management
August:
Novel Technologies for Antibody Drug Discovery in Japan
September:
Infectious Diseases
October:
Medical Tourism
November:
Big Data in Healthcare
December:
Orthopaedics
Editorial calendar is subjected to changes.
– Editor: Carmen, Jia Wen Loh
MAGAZINE TAGS
About Us
Events
Available issues
Editorial Board
Letters to Editor
Instructions to Authors
Advertise with Us
CONTACT
World Scientific Publishing Co. Pte. Ltd.
5 Toh Tuck Link, Singapore 596224
Tel: 65-6466-5775
Fax: 65-6467-7667
» For Editorial Enquiries:
   biotech_edit@wspc.com or Ms Carmen
» For Subscriptions, Advertisements &
   Media Partnerships Enquiries:
   biotech_ad@wspc.com
Copyright© 2016 World Scientific Publishing Co Pte Ltd  •  Privacy Policy