Tags : ODD

AbbVie’s Elezanumab (ABT-555) Receives the US FDA’s Orphan Drug and

Shots:   The US FDA has granted ODD and FT destination to Elezanumab, which is an investigational treatment for patients following spinal cord injury The company is collaborating with Shirley Ryan AbilityLab and MC10 to evaluate elezanumab in a pilot study in 20 spinal cord injury patients. The pilot study will inform the ongoing P-II study […]Read More

BioLineRx’s Motixafortide (BL-8040) Receives EC’s ODD to Treat Pancreatic Cancer

Shots: The EC has granted ODD to Motixafortide (BL-8040) for the treatment of pancreatic cancer following the positive COMP’s opinion The ODD designation is based on initial data of ongoing P-IIa COMBAT/KEYNOTE-202 study assessing the combination of BL-8040 + Keytruda (pembrolizumab) + CT in patients with m-pancreatic cancer Motixafortide is a selective inhibitor of the […]Read More

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

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 […]Read More

Albireo’s A4250 Receives EU Orphan Drug Designation (ODD) for Biliary

Shots: The designation is based on P-III clinical trial assessing A4250 in patients with progressive familial intrahepatic cholestasis (PFIC) Albireo to get 10 years of market exclusivity with additional two years on completion of pediatric investigation plan (PIP) and plans to target A4250 in rare cholestatic liver diseases in 2019 A4250 is an ileal bile acid transporter (IBAT) inhibitor, indicated to […]Read More