Shots: The EC has granted ODD for PBKR03 for the treatment of Krabbe disease. The ODD was based on an EMA’s COMP positive opinion The designation provides potential benefits to the company, which include clinical protocol assistance, reduced regulatory fees, research grants, and up to 10 years of market exclusivity following regulatory approval The company […]Read More
Shots: The US FDA has granted ODD to Prosetin for the treatment of ALS. ODD provides incentives for the development of drugs, biologics, and devices for diseases affecting 200,000 or fewer Americans By obtaining ODD, Prosetin is now eligible for benefits including up to 7yrs. of marketing exclusivity if it receives regulatory approval, exemption from […]Read More
Shots: The US FDA has granted ODD and RPD to the Taysha Gene Therapies’ TSHA-101 for GM2 Gangliosidosis. The company expects the therapy to enter the clinic by the end of 2020 The US FDA’s two designations demonstrated the strength of the translational data package supporting TSHA-101 for GM2 Gangliosidosis TSHA-101 is an AAV9-based gene […]Read More
Shots: The US FDA has granted ODD for Kiniksa’s Rilonacept to treat pericarditis, which includes recurrent pericarditis. The company plans to submit sBLA in recurrent pericarditis to the US FDA in late 2020 Earlier, the company has reported the results of P-III RHAPSODY study that met its all 1EPs & 2EPs showing that the therapy […]Read More
Shots: The ODD designation follows P-I/II SPRINT Stratum 1 study assessing Selumetinib (bid) as monothx. in pediatric patients with NF1-related inoperable PNs The P-I/II SPRINT Stratum 1 study demonstrated a reduction in the size of tumors with 66% ORR in children. AstraZeneca and MSD are co-developing and co-commercializing selumetinib which received the US FDA’s approval […]Read More
Shots: The US FDA’s ODD is based on P-II DESTINY-Gastric01 study assessing Enhertu (6.4 mg/kg, q3w) vs CT in 188 patients in a ratio (2:1) with HER2-expressing, advanced gastric cancer, progressed with 2+ prior treatment regimens including 5-FU, Pt. CT and trastuzumab The study demonstrated improvement in ORR & OS and will be presented at […]Read More
Shots: The ODD is based on P-III POLO study assessing Lynparza (300mg, bid) as maintenance monothx. vs PBO in 154 patients in a ratio (3:2) with gBRCAm metastatic PC without disease progression on 1L Pt. based CT The P-III POLO study results: improvement in PFS (7.4 vs 3.8mos.); 47% reduction in disease progression; patients with […]Read More
Shots: The MHLW has granted Chugai’s RG6042 an ODD for the expected treatment of Huntington’s disease The RG6042 is currently being evaluated in P-III GENERATION HD1 study and is expected to delay the progression of Huntington’s disease as the first disease-modifying therapy RG6042 (ONIS-HTTRx) is an antisense oligonucleotide targeting HTT mRNA and has received FDA […]Read More
Shots: The US FDA has granted ODD to the OBI-999 for the treatment of gastric cancer. This marks the second ODD to the therapy as it has already received the FDA’s ODD to treat pancreatic cancer on Dec 26, 2019 The US FDA grants ODD to therapies intended to treat, diagnose or prevent rare diseases […]Read More
Shots: The ODD is based on P-III HIMALAYA study assessing Imfinzi as monothx., a combination of Imfinzi and tremelimumab vs SOC (sorafenib) in patients with unresectable advanced HCC, prior not treated with systemic therapy across 16 countries including the US, EU, Canada, South America and Asia The US FDA grants ODD to therapies intended to […]Read More
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