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A batch of world's first drugs in Zhangjiang pharmaceutical Valley
Time of Update: 2015-08-17
On August 7, Zhangjiang biomedical base and Pudong New Area Biological Industry Association jointly launched the opening show of "Zhangjiang pharmaceutical Valley innovation release" -- the world's fi
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CDE drug review weekly report (August 9, 2015 to August 15, 2015)
Time of Update: 2015-08-17
1 in the review this week (2015.8.9-2015.8.15), 87 drugs (calculated by acceptance number) entered the review status, 76 chemicals, slightly less than last week, including 3 1.1, 1 1 1.3, 1 1 1.6, 2 2
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Fangsheng Pharmaceutical Group 1.1 new chemical drug diantikang sodium for injection approved clinical
Time of Update: 2015-08-14
According to the latest information from CFDA, a new chemical drug with acceptance No "cxhl1301089 Xiang" of Fangsheng pharmaceutical has been approved for clinical application At present, the process
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Rolapitant, a patent antiemetic drug introduced by Hengrui tesaro for tumor adjuvant treatment
Time of Update: 2015-08-13
On July 30, 2015, Hengrui issued a notice: Jiangsu Hengrui Pharmaceutical Co., Ltd reached an agreement with American tesaro company to introduce rolapitant, a patent antiemetic drug of tesaro (NASDAQ
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About to become 7 kinds of domestic heavy new drugs
Time of Update: 2015-08-13
Among the 16 companies (R & D pharmaceutical companies) with R & D investment of more than 5%, which new or upcoming varieties are the most innovative and have great potential? Not long ago, pharmaceu
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The first successful implementation of car-t immunocytotherapy in Anhui Province
Time of Update: 2015-08-12
On August 11, Xiaolei, a 6-year-old child with leukemia, received car-t cell immunotherapy in the Department of Hematology, the Second Affiliated Hospital of Anhui Medical University After receiving c
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Review of new drugs in China in the first half of 2015
Time of Update: 2015-08-12
First: the review was accelerated, and the number of approved clinical new drugs doubled The Insight China Pharma data database of DXY continued to count the drugs approved by CFDA in the first half o
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CDE drug review weekly report (2015.8.2-2015.8.8)
Time of Update: 2015-08-10
1 in the review this week (2015.8.2-2015.8.8), 89 drugs (calculated by acceptance number) entered the review status, 83 chemicals, including 35 drugs in 3.1, 2 drugs in 3.2, 1 drug in 3.3, 4 drugs in
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Hydroxypiperone hydrochloride, a class 1.1 new drug of Huahai pharmaceutical, has obtained the clinical approval, and the industrial upgrading is in progress
Time of Update: 2015-08-06
Introduction to this report: the company announced that 1.1 type of chemical drug, mepyridone hydrochloride, has obtained the approval of clinical trials The company has continued to lay out in the fi
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A large wave of new drugs of category 3.1 were withdrawn from the trial
Time of Update: 2015-08-06
Recently, Ding Xiangyuan's insight database and medicine magic square website show that: since July 23, the status of some clinical applications for class 3.1 new drugs has become "approved - to be ce
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CDE drug evaluation: 845 757 chemicals in total
Time of Update: 2015-08-06
On July 22, the State Food and Drug Administration (CFDA) issued a notice requiring 1622 registrants with acceptance number to carry out self inspection and verification of drug clinical trial data If
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Bgb-283, the second generation BRAF inhibitor of Baiji Shenzhou class 1 new drug, obtained CFDA clinical approval
Time of Update: 2015-08-05
According to the official website of Baiji, bgb-283, a new drug independently developed by Baiji, targeting antitumor drug B-Raf dimer inhibitor, has recently obtained the approval document for clinic
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CDE drug review report in July 2015
Time of Update: 2015-08-04
In July, the hot CFDA issued two announcements to solve the drug review problem Seven new drugs of class 1.1 were applied for clinical application The first imported drugs of class 3.1 rushed to imita
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CDE Drug Evaluation Weekly Report (2015.7.19-2015.7.25)
Time of Update: 2015-08-03
In the review this week (2015.7.26-2015.8.1), 92 drugs (calculated by acceptance number) entered the review status, 82 chemicals, including 2 1.1 categories, 1 1 1.6 category, 30 3.1 categories, 4 3.2
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Yang Dajun: let the clinical trial filing system take the lead in the field of tumor drugs
Time of Update: 2015-08-03
When he was a university student, he became a celebrity of his time because of his participation in the well-known family doctor magazine Later, his further study in the United States gradually faded
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Global declaration from July 27 to July 31, 2015
Time of Update: 2015-08-02
1 Approval of new drugs 1 On July 30, 2015, the European Union approved the use of abelvidamumumab in the treatment of suppurative sweat gland inflammation 2 Recognition of breakthrough therapy 1 On J
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Approved clinical application of c118p for injection of Shenghe pharmaceutical
Time of Update: 2015-07-28
C118p for injection was applied by Nanjing Shenghe Pharmaceutical Co., Ltd and entered the CDE evaluation sequence in August 2014 It is a major special variety and a special approved variety, which ha
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CDE Drug Evaluation Weekly Report (2015.7.19-2015.7.25)
Time of Update: 2015-07-28
In the review this week (2015.7.19-2015.7.25), 117 drugs (calculated by acceptance number) entered the review status, 110 chemicals, including 5 1.1, 60 3.1, 4 3.2, 2 3.3, 3 5, 25 6, 9 imports In addi
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Beihai Kangcheng cooperates with apogenix in the development of new GBM monoclonal antibody apg-101
Time of Update: 2015-07-21
On July 15, 2015 Beijing time, Beihai Kangcheng (Beijing) Pharmaceutical Technology Co., Ltd (hereinafter referred to as "Beihai Kangcheng") and apogenix GmbH of Germany (hereinafter referred to as "a
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13 kinds of compound vitamin injection, a new chemical drug of 3.2 category of Hisilicon, will enter the on-site inspection this month, and will become the first imitation after being approved
Time of Update: 2015-07-21
According to the information on the website of CFDA, 13 kinds of compound vitamin injection, a new chemical drug of 3.2 category of HISCO (002653 SZ), will enter the drug registration and production s
