EPISODE 19 | 12 MIN | 30 Aug. 2022
EU issues GMP Annex 1 final revision for sterile drug products
EPISODE 19 | 12 MIN | 30 Aug. 2022
#Drug Review #R&D #Business #Policy
EU issues GMP Annex 1 final revision for sterile drug products
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Summary
In the last week's Chinese pharma market, the 11th indication of BeiGene’s PD-1 Tislelizumab was declared for marketing for the treatment of esophageal squamous cell carcinoma. While in the global pharma market, Johnson & Johnson’s Teclistamab was approved by the EC, making it the first BCMA/CD3 bispecific antibody approved for marketing worldwide. In addition, the EU officially released the eagerly anticipated final revision of its GMP Annex 1 for sterile drug products. Other pharma news collected in this episode covers 4 sections including drug review, R&D, business, and policy.
Timeline
1
PART1 | 01:04
The new indication of BeiGene Tislelizumab was accepted by the NMPA
2
PART2 | 01:39
The clinical trial application for Ascletis’ASC10 was approved
3
PART3 | 02:10
Shanghai Pharma's B013 injection was approved by the NMPA for Phase II clinical trials
4
PART4 | 02:42
The 4th-generation EGFR inhibitor of Qilu Pharmaceutical QLH11811 was approved for clinical use
5
PART5 | 03:35
Junshi Biosciences's anti-CD112R monoclonal antibody injection was approved by the CDE for clinical trials to treat advanced solid tumors
6
PART6 | 04:04
Tiannuo Jiancheng's monoclonal antibody targeting CCR8, CM369, was approved for clinical trials
7
PART7 | 04:38
The clinical trial application of Akeso's AK129 injection was accepted for the treatment of cancers
8
PART8 | 05:25
The clinical trial application of BavarianNordic and Nuance's MVA-BNRSV vaccine was accepted for the prevention of RSV infection
9
PART9 | 05:44
The clinical application of Roche Tiragolumab injection was accepted again by the CDE
10
PART10 | 06:24
Pfizer and BioNTech applied to the FDA for EUAof OmicronBA.4/BA.5-adapted bivalent COVID-19 mRNA vaccine for individuals 12 years of age and older
11
PART11 | 06:52
MinervaNeurosciences submitted an NDA for roluperidone to the FDA for the treatment of negative symptoms in patients with schizophrenia
12
PART12 | 07:11
The EC had approved Gilead's lenacapavir (brand name: Sunlenca) injection and tablets
13
PART13 | 07:37
The EC approved the conditional marketing of BioMarin's Roctavian gene therapy
14
PART14 | 08:11
The EC approved Johnson & Johnson's Teclistamab as a monotherapy for the treatment of adult patients with RRMM
15
PART15 | 08:43
The clinical trials of AstraZeneca/Ionis AZD8233 injection had been initiated in China
16
PART16 | 09:09
Apellis announced key results from two Phase III trials of its targeted complement C3 therapy pegcetacoplan
17
PART17 | 09:36
Novartis decided to temporarily suspend the ongoing Phase IIb clinical study evaluating its experimental Huntington's disease drug branaplam
18
PART18 | 10:05
Hansoh Pharmaceutical Group's wholly-owned subsidiary entered into an exclusive licensing and co-development agreement with GHDDI
19
PART19 | 10:48
Novartis announced its intention to separate its generic drug and biosimilar division into a newly listed independent operating company
20
PART20 | 11:24
The EU issues GMP Annex 1 final revision for sterile drug products
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