Shots: The NDA is based on STORM and SADAL studies. The P-IIb STORM study involves assessing of ATG-010 + low-dose dexamethasone in patients with rrMM prior treated with at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 mAb The P-II SADAL study […]Read More
Shots: Chi-Med initiated the filing of NDA to the US FDA for surufatinib to treat pancreatic & non-pancreatic NET & plans to complete the NDA submission in the H1’21 The NDA is based on two P-III studies that demonstrated a reduction in risk of progression or death by 67% & 51%, extending PFS of non-pancreatic […]Read More
Shots: The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy The study provided durable anticancer activity with a positive benefit-risk profile The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures […]Read More
Shots: The US FDA has accepted the NDA and granted PR for TAK-721 for the treatment of EoE. If approved, TAK-721 will be the first FDA-approved treatment for EoE and Takeda plans to launch it under the trade name Eohilia The NDA filing is based on P-III ORBIT-1 and ORBIT-2 studies which evaluated the safety […]Read More
Shots: The P-III HLX04-mCRC03 study involves assessing the efficacy, safety and immunogenicity of HLX04 vs reference bevacizumab (7.5 mg/kg, q3w or 5 mg/kg, q2w) + CT (Xelox or mFOLFOX6) as a 1L treatment in patients in the ratio of (1:1) with mCRC Result: PFSR36wk (46.4% vs 50.7%); no significant difference b/w the treatment groups in […]Read More
Shots: The acceptance marks the first marketing application accepted for achondroplasia in the US with an anticipated PDUFA date as of Aug 20, 2021. The US FDA is not planning to hold an advisory committee meeting to discuss the application Additionally, the company is expecting to complete enrollment in a P-II study assessing vosoritide in […]Read More
Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with […]Read More
Shots: The NDA submission is based on P-III UPTRAVI IV study he safety and tolerability of 20 patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose Results demonstrated that Uptravi IV is suitable to maintain continuous dosing for short periods of time when the […]Read More
Shots: NMPA has accepted the NDA of HLX04, based on the series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies & clinical studies. The NDA acceptance makes HLX04 the fourth product of Henlius that has received NMPA’s NDA acceptance & can be potentially used for the treatment of advanced/ metastatic or recurrent […]Read More
Shots: Athena Biosciences announced that the US FDA has approved Qdolo (tramadol hydrochloride) oral solution 5mg/1mL C-IV The most common AE’s (≥15.0%) observed in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, and pruritus Qdolo is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative […]Read More
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