Taiwan Liposome’s TLC178 Receives EMA’s ODD for Soft Tissue Sarcoma (STS)

 Taiwan Liposome’s TLC178 Receives EMA’s ODD for Soft Tissue Sarcoma (STS)

Taiwan Liposome’s TLC178 Receives EMA’s ODD for Soft Tissue Sarcoma (STS)

Shots:

  • The ODD follows P-I/II study assessing TLC178 in patients with advanced malignancies in adults and has resulted in no dose-limiting toxicity till date
  • The EMA’s Orphan Drug Designation (ODD) is granted to the therapies offering life-threatening condition affecting ≤5 in 10,000 persons in EU, with no approved treatment and receiving 10-year of marketing exclusivity in EU on approval
  • TLC178 is a liposomal formulation of vinorelbine (a chemotherapy drug) based on Taiwan’s NanoX technology and has received FDA’s Rare Pediatric Disease Designation for RMS in April 2017

Click here to read full press release/ article | Ref: Globe Newswire | Image: Twitter

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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