EPISODE 22 | 16 MIN | 20 Sep. 2022
The World’s First FDA-Approved Therapy to Improve Renal Function of Adult HRS Patients
EPISODE 22 | 16 MIN | 20 Sep. 2022
#Drug Review #R&D #Business
The World’s First FDA-Approved Therapy to Improve Renal Function of Adult HRS Patients
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Summary
This week, in China, Humanwell Healthcare's Class 1.2 traditional Chinese medicine was approved for marketing. Pearl Bio's Bozitinib enteric capsule was planned to be included for priority approval. While globally, the terlipressin injection became the world's first FDA-approved therapy to improve renal function in adult patients with hepatorenal syndrome (HRS).
Timeline
1
PART1 | 00:59
Humanwell Healthcare's Desmodium styracifolium total flavonoids capsule, a class 1.2 traditional Chinese medicine was approved for marketing
2
PART2 | 01:39
Haihe Biopharma and Daehwa Pharmaceutical submitted an application for the marketing of Liporaxel (RMX3001)
3
PART3 | 02:22
Renocell Biotech's RY-SW01 cell injection was approved for clinical use to treat active lupus nephritis
4
PART4 | 02:48
Hengrui Medicine's HRS-6209 capsule was approved for clinical use
5
PART5 | 03:18
AstraZeneca's CAEL-101 injection was approved for clinical use, intended for the indication of amyloid light chain amyloidosis
6
PART6 | 03:46
Idorsia Pharmaceuticals' selatogrel injection was approved for clinical use
7
PART7 | 04:16
Biogen's BIIB122 was approved for clinical use for the treatment of Parkinson's disease
8
PART8 | 04:39
I-Mab Biopharma's third-stage registered clinical study of CD47 antibody lemzoparlimab combined with azacytidine was approved
9
PART9 | 05:15
The clinical trial application for Eli Lilly and Dicerna's LY3819469 injection was submitted and processed
10
PART10 | 05:45
Jing Medicine's clinical trial application for HJM-353 tablets was submitted and processed
11
PART11 | 06:11
Pearl Bio's c-Met inhibitor, Bozitinib enteric capsule was proposed to be given priority review
12
PART12 | 06:35
Mallinckrodt's terlipressin injection became the world's first FDA-approved therapy to improve renal function in adult HRS patients
13
PART13 | 07:05
Acadia Pharmaceuticals announced that the FDA had processed and granted priority review to Trofinetide's new drug application (NDA)
14
PART14 | 07:32
Luye Pharma announced that LY03015 was approved by the FDA and would soon be under Phase I clinical trial
15
PART15 | 08:00
Transcenta Group announced that its clinical trial application of TST003 was approved by the FDA
16
PART16 | 08:28
Mersana's XMT-1660 had been granted FTD by the FDA for the treatment of adult patients with advanced or metastatic TNBC
17
PART17 | 08:55
aTyrPharma's efzofitimod was granted FTD by the FDA for the treatment of interstitial lung disease related to systemic sclerosis
18
PART18 | 09:22
Alphamab Oncology's Envafolimab monoclonal antibody injection was granted FTD by the FDA
19
PART19 | 09:53
Jasper Therapeutics's JSP191 was granted FTD by the FDA
20
PART20 | 10:38
MC2 Therapeutics announced that the first patients have been dosed in its Phase II clinical trial, MC2-25-C1
21
PART21 | 11:17
Daiichi Sankyo and Sarah Cannon Research Institute announced that DS-7300 Continues to Show Promising Durable Response in Patients with Several Types of Advanced Cancer
22
PART22 | 11:54
Zelgen announced success in its Phase II clinical trial (ZGJAK008) of the Jaktinib hydrochloride tablets
23
PART23 | 12:17
Altimmune announced the results from its Phase Ib study of pemvidutide in patients with nonalcoholic fatty liver disease
24
PART24 | 12:52
Eloxx Pharmaceuticals Reports Topline Results from Phase 2 Combination Clinical Trial of ELX-02 in Class 1 Cystic Fibrosis (CF) Patients
25
PART25 | 13:20
Revance Therapeutics announced the positive results of its Phase II JUNIPER clinical trial evaluating the long-term efficacy and safety of DaxibotulinumtoxinA-lanm injection
26
PART26 | 13:50
NeuroBo and Dong-A announce strategic collaboration to license and develop portfolio of Dong-A's cardio-metabolic therapies
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