Global experts discuss regulatory innovations – accelerators for the approval of orphan drugs
Exhibitor: ONLY ORPHANS COTE LLC
Date: 2024-05-30
Booth No.: L724
Dr. Timothy Cote, former Director of the FDA Office of Orphan Products Development and Founder & CEO of Only Orphans Cote, shared his insights on "FDA Orphan Drug Designation: A Visa to the U.S. Market."
Dr. Cote expressed his pleasure at seeing more and more Chinese companies seeking to obtain orphan drug designation from the U.S. Food and Drug Administration (FDA). He pointed out that orphan drug designation offers numerous benefits to companies. Firstly, the designation grants companies market exclusivity for up to seven years, which has the advantage of not requiring frequent legal defenses compared to patents. Secondly, the U.S. market is highly profitable, which not only motivates new drug development but also benefits patients. Additionally, companies with orphan drug designation enjoy tax incentives. Dr. Cote emphasized that the sooner a company obtains orphan drug designation, the more advantageous it is. The two main criteria for orphan drug designation are the medical rationale standard and the prevalence standard. He expressed his delight at the increasing number of Chinese companies willing to participate in orphan drug designation and warmly welcomed these companies to target the U.S. market.
More Exhibitor's Press Release
- Vitae Biomedical's Urine Testing Platform Targets Lung Cancer, Lowering Testing Barriers VITAE BIOMEDICAL CO. LTD. / 2024-08-15
- Comparison of Maglev Centrifugal Pump and Quaternary Diaphragm Pump Effects on mRNA encapsulated LNP LEVITRONIX GMBH TAIWAN BRANCH / 2024-07-31
- HONG SHENG PRECISION BIOTECH: What is Metabolomics Research? HONG SHENG PRECISION BIOTECH CO., LTD. / 2024-07-29
- SCI's highest quality static control equipment-------your best choice!! CHAO-DEE SCIENCE CO., LTD. / 2024-07-23
- High-Throughput NGS Assistant - Feyond-F100 Fluorescence Microplate Reader MEDCLUB SCIENTIFIC CO., LTD. / 2024-07-23
- CLUBIO Life science solutions help universities upgrade equipments MEDCLUB SCIENTIFIC CO., LTD. / 2024-07-23
- CRISPR cGMP gRNA Manufacturing MEDCLUB SCIENTIFIC CO., LTD. / 2024-07-23
- INORA Brand Strategy to Drive Revenue Growth INORA PHARMACEUTICAL MACHINERY CO., LTD. / 2024-07-22
- HONG SHENG PRECISION BIOTECH 2024 BIO Asia-Taiwan Exhibition Activity: Fill out a survey and receive HONG SHENG PRECISION BIOTECH CO., LTD. / 2024-07-22
- Vitae Biomedical's Revolutionary Tool: The "Urine-based Lung Cancer Antigen Detection Kit" VITAE BIOMEDICAL CO. LTD. / 2024-07-22
- HONG SHENG PRECISION BIOTECH Showcases Leading Technology and Services on Metabolomic Testing HONG SHENG PRECISION BIOTECH CO., LTD. / 2024-07-19
- OEM by QIAGEN: Strategic Partnerships – A Partner that Extends Your Capabilities QIAGEN N.V. / 2024-07-18
- Featured Product: Saltonase, the Versatile Nuclease - Salt Tolerant and Easier Purification QIAGEN N.V. / 2024-07-18
- Featured Product: QIAGEN Beverly Single-Tube Enzymatic Fragmentation Library Preparation QIAGEN N.V. / 2024-07-18
- Join TaiMed Biologics and Lourdes for Inspiring Activities at BioAsia 2024 TAIMED BIOLOGICS INC. / 2024-07-17
- Helping the elderly to age healthily, Hujia Biomedicine demonstrates high-quality innovative researc HUJIA BIOMEDICAL CO., LTD. / 2024-07-17
- Innovative cooperation between Hujia Biomedical Co., Ltd. and National University HUJIA BIOMEDICAL CO., LTD. / 2024-07-17
- PanOmiQ- World's Fastest Genomic Analysis Software BIOARO INC. / 2024-07-17
- PERNATON wins the 2024 National Biotechnology Award PINYIN HEALTH & LIVING, INC. / 2024-07-16
- Truking releases the innovative intelligent automatic light Inspection machine: AIM72 UTEK INTERNATIONAL CORPRATION / 2024-07-15
