EPISODE 14 | 11 MIN | 04 May 2022
Weekly Pharma News Review (0424-0501)
EPISODE 14 | 11 MIN | 04 May 2022
#Drug Review #R&D #Business
Weekly Pharma News Review (0424-0501)
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Summary
The Virtual Expo Connect 2022 is in full swing this week. Cameron Bardliving, the director of operations from Jefferson Institute for Bioprocessing, and GlobalData's senior director Peter Shapiro appeared in the VEC webinar and conducted in-depth sharing and discussion focusing on new cell and gene therapies. Looking back on the pharma news of this week, AstraZeneca and Daiichi Sankyo’s HER2-directed antibody-drug conjugate Enhertu has been granted Breakthrough Therapy Designation for patients with HER2-low metastatic breast cancer in the US. While in China, its marketing application for the treatment of patients with HER2-positive unresectable or metastatic breast cancer treated with one or more prior anti-HER2-based regimens was proposed to be included in the updated publicity list of priority review.
Timeline
1
PART1 | 00:17
VEC webinar: Bio Insights: Cell and Gene Therapy
2
PART2 | 01:24
Jingxin Pharmaceutical submitted the application for a first-in-class drug, EVT201 capsule, for insomnia
3
PART3 | 01:53
CDE accepted the marketing application of Qilu Pharmaceutical's dolutegravir sodium
4
PART4 | 02:21
Bayer's marketing application for new indications of darolutamide tablets for the treatment of mHSPC was accepted
5
PART5 | 02:47
Biotech Pharma's marketing application for new indications of nimotuzumab injection was accepted
6
PART6 | 03:08
Suzhou Zelgen Biopharmaceuticals announced the submission of the marketing application for its recombinant human thrombin for external use
7
PART7 | 03:35
Qilu Pharmaceutical's Aflibercept Intravitreous Injection was accepted for a marketing application
8
PART8 | 04:06
The first-in-class drug of Henlius, HLX53 was declared for clinical use
9
PART9 | 04:37
Allogeneic EPCs injection ALF201, declared by Allife Medicine had acquired an implied license for clinical trials
10
PART10 | 05:08
A new indication of Eli Lilly's GLP-1R/GIPR double agonist, Tirzpatide, was approved for a clinical trial in China
11
PART11 | 05:36
CDE planned to include Allist's Furmonertinib Mesilate Tablets in breakthrough therapy
12
PART12 | 05:56
CDE intended to include the marketing application for Enhertu of Daiichi Sankyo/AstraZeneca in the updated publicity list of priority review
13
PART13 | 06:24
AstraZeneca and Daiichi Sankyo's Enhertu had acquired Breakthrough Therapy Designation from FDA
14
PART14 | 06:51
AstraZeneca announced that the BLA for the indication of unresectable hepatocellular carcinoma was accepted by FDA
15
PART15 | 07:27
FDA granted OncoC4's ONC-392 Fast Track as a monotherapy
16
PART16 | 08:06
Innolake Biopharm announced that patient dosing of ILB-2109 had been achieved for the first time in the Phase 1a clinical trials for the advanced solid tumors
17
PART17 | 08:27
VITRAC announced the launch of Phase 1/2 clinical trials to evaluate the safety and efficacy of VIC-1911 combined with sirolimus and PTCy
18
PART18 | 08:52
Novartis's Zolgensma was put into clinical practice in China for the first time
19
PART19 | 09:25
BeiGene's global Phase III clinical trial of PD-1 monoclonal antibody Tislelizumab in the first-line treatment of ESCC had acquired promising results
20
PART20 | 09:52
Arrowhead established a joint venture company Visirna with Vivo Capital and signed a licensing agreement with Visirna
21
PART21 | 10:20
Xbiome acquired the clinical-stage M201 from Assembly Biosciences
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