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The State Food and Drug Administration issued a notice on timely submission of the original and auxiliary package annual report
Time of Update: 2021-07-30
The relevant content of the annual report system for the original and auxiliary package is summarized as follows:(1) On November 23, 2017, the State Administration issued the "Announcement on Adjusting the Review and Approval of APIs, Pharmaceutical Excipients and Pharmaceutical Packaging Materials (2017 No.
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The first class 1 new drug!
Time of Update: 2021-07-30
On July 24, the CDE official website showed that Qilu Pharmaceutical submitted and accepted a listing application for a new class 1 drug "Yiluok Tablets" .
In October 2019, Qilu initiated a phase III clinical study (CTR20191231) comparing WX-0593 tablets and crizotinib in the treatment of ALK-positive non-small cell lung cancer.
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Gao Fu and others review how Qingdao dockers were infected with the new crown
Time of Update: 2021-07-30
In fact, on October 17th last year, the official website of the China Centers for Disease Control and Prevention announced that, in the process of the traceability investigation of the new crown pneumonia epidemic in Qingdao, the China Centers for Disease Control and Prevention tested positive samples from the outer packaging of imported frozen cod carried by workers.
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my country's inhaled new crown vaccine clinical trial results are recognized by authorities
Time of Update: 2021-07-30
At the same time, aerosol inhalation can also significantly improve the multiple immune effects of people who have been injected with the vaccine, resist the mutation of the new coronavirus, and is suitable for large-scale population promotion .
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Experts interpret the delta strain: highly infectious and highly atypical symptoms
Time of Update: 2021-07-30
In Qiu Haibo's view, the currently established diagnosis and treatment programs are effective for most patients .
Qiu Haibo believes that the Delta strain has the characteristics of strong transmission ability, fast transmission speed, and atypical symptoms .
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Sichuan pharmaceutical companies are showing off!
Time of Update: 2021-07-30
Recently, the good news of Better Pharmaceutical's product line has continued: Cefmetazole Sodium for Injection was the first to have been evaluated, and the Class 1 new drug BT-101094 capsule was approved for clinical use, and it has reached a cooperation with Guangzhou Kangchen in the field of contrast agents .
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Tracing to the wrong direction: conspiracy to cover up science and politics to replace the truth
Time of Update: 2021-07-30
After the World Health Organization expert team went to China this year to jointly conduct a 28-day field study, it has reached important conclusions: the source of the new coronavirus is "very likely" from animals or nature; "very unlikely" is from laboratory leaks .
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Singaporean scholars: oppose the politicization of the origin of the new crown virus
Time of Update: 2021-07-30
Ma Kai Singapore's former Permanent Representative of the United Nations, excellent Asian Institute, National University of Singapore Academy of Sciences Ma Shuo said that since the new crown outbreak, the United States and other Western countries continue to be stigmatized virus traceability issues, politicized .
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Experts explain in detail: Is the new crown vaccine boosted?
Time of Update: 2021-07-30
Jin Dongyan believes that foreign countries have already implemented the new crown vaccine booster injection for some people, and this issue should also be considered in China .
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WHO: Delta mutant virus has spread to 132 countries and regions
Time of Update: 2021-07-30
According to data from the World Health Organization, as of July 28, there were more than 195 million confirmed cases of COVID-19 worldwide and more than 4.
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"The Lancet": Infecting New Crown or Affecting Intelligence
Time of Update: 2021-07-30
Liu Xia Between January and December last year, researchers from Imperial College, King’s College, University of Cambridge, University of Southampton and University of Chicago conducted intelligence tests on 81,337 people-including about 13,000 people infected with the new crown virus.
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Gao Fu: Vaccines can provide basic immunity and significantly reduce the burden of disease
Time of Update: 2021-07-30
China News Service, Beijing, July 27 (Hao Lingyu) Regarding whether the new crown pneumonia vaccine is effective for mutant virus strains, Gao Fu, director of the China Centers for Disease Control and Prevention, stated in Beijing on the 27th that the vaccine can provide basic immunity and be effective in reducing the burden of disease.
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The "dual channel" of centralized procurement and national talks promotes changes in the pharmaceutical industry
Time of Update: 2021-07-30
"Make space, adjust structure, and ensure convergence", policy and supervision are linked together In recent years, the reform of medical insurance has been continuously explored and improved to promote the refined management of hospitals , which has a profound impact on the development of the industry .
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Second-line indications for liver cancer: What is the efficacy of domestic PD-1 when drug O is withdrawn and drug K is approved?
Time of Update: 2021-07-30
However, in the confirmatory clinical trial CheckMate-459, according to the pre-specified analysis, O drug and sorafenib first-line treatment of liver cancer, although the ORR data consistent with the previous accelerated approval was achieved, the primary endpoint of OS did not reach the statistics.
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Inventory of my country's drug traceability system regulatory policy release overview
Time of Update: 2021-07-30
In order to promote the construction of the drug information traceability system and guide enterprises to carry out the specific implementation of drug traceability codes, on June 21, 2021, the official website of the State Food and Drug Administration released the " Drug Traceability Code Printing Specification" and "Drug Traceability Code Consumer Inquiry Results Display Specification" "Two informatization standards solicitation drafts.
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39 drugs will increase in price
Time of Update: 2021-07-30
"According to the notice, there are 2031 drugs to be increased in the dynamic adjustment of centralized drug procurement in 2020, of which 39 meet the price adjustment conditions, 358 have applied for an extension of the market approval window, and 7 enterprises will be adjusted after the establishment of an enterprise complaint and will be adjusted after expert evaluation.
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Domestic bevacizumab accelerates its competition for the "tens of billions" market
Time of Update: 2021-07-30
Combined treatment effect "1+1>2 " Statistics from the International Agency for Research on Cancer (IARC) of the World Health Organization show that in 2020, among the new cancers in China, the top ten cases are lung cancer, colorectal cancer, gastric cancer, breast cancer, liver cancer, esophageal cancer, and thyroid cancer.
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Hengrui Medicine Fondaparinux Sodium Injection Passed Consistency Evaluation
Time of Update: 2021-07-30
On July 28, Hengrui Medicine issued an announcement stating that it had recently received the "Drug Supplementary Application Approval Notice" for Fondaparinux Sodium Injection approved and issued by the State Food and Drug Administration, and the drug passed the consistency evaluation of generic drugs .
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Local rules for the management of traditional Chinese medicine formula granules are implemented!
Time of Update: 2021-07-30
Fully liberalized access Establish the only procurement channel According to the "Announcement", Hainan Province requires in the "Implementation Rules" that enterprises that produce granules of traditional Chinese medicine should obtain the "Drug Production License" and have the scope of production of Chinese medicine decoction pieces and granules .
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BMS withdraws approval of Opdivo monotherapy for Nexavar treatment failure liver cancer indication
Time of Update: 2021-07-30
CompilationTom LeeA few days ago, Bristol-Myers Squibb stated that it would voluntarily withdraw Opdivo's indication approval for hepatocellular carcinoma patients who have previously received Nexavar treatment and have failed the treatment .