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The first domestic product! Connoa's TSLP monoclonal antibody is approved for clinical treatment of atopic dermatitis
Time of Update: 2021-11-14
Article source: Medical Rubik's Cube InfoAuthor: SunshineOn November 3, Connoa announced that the CM326 clinical trial application was approved by the Food and Drug Administration for the treatment of atopic dermatitis .
CM326 is the first domestic TSLP targeting antibody in China and the third in the world to be approved for clinical trial applications .
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2020 Chinese Hospitals and Chinese Medical Colleges Science and Technology Values (STEM) released
Time of Update: 2021-11-14
( Photo courtesy of the Chinese Academy of Medical Sciences) The picture shows Wang Chen interpreting and releasing the 2020 STEM values for Chinese hospitals/medical colleges .
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[FDA] The first C5aR inhibitor comes out!
Time of Update: 2021-11-14
S. FDA announced the approval of ChemoCentryx's oral selective complement 5a receptor (C5aR) inhibitor Tavneos (avacopan) to be marketed, combined with standard therapies to treat severely active antineutrophil cytoplasmic autoantibodies (ANCA) ) Related vasculitis, including granulomatous polyangiitis (GPA) and microscopic polyangiitis (MPA) .
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Announcement of the State Food and Drug Administration on Revising the Instructions for Diammonium Glycyrrhizinate Preparations (No. 107 of 2021)
Time of Update: 2021-11-14
The marketing authorization holders of the above-mentioned drugs shall comply with the relevant provisions of the "Administrative Measures for Drug Registration" and other relevant regulations, in accordance with the revised requirements of the instructions for diammonium glycyrrhizinate oral preparations and diammonium glycyrrhizinate injection preparations (see attachment) , Before December 2, 2021, report to the Drug Evaluation Center of the National Medical Products Administration or the provincial drug regulatory authority for record .
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Announcement of the State Food and Drug Administration on the conversion of aloe pearl capsule prescription drugs to over-the-counter drugs (No. 115 of 2021)
Time of Update: 2021-11-14
The contents of the non-prescription drug inserts other than those specified in the template inserts shall be implemented in accordance with the original approval documents .
Variety of non-prescription drug instructions template State Drug Administration September 23, 2021 State Drug Administration Announcement No.
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Announcement of the State Food and Drug Administration on Revising the Instructions for Ginkgo Damo Injection (No. 71 of 2021)
Time of Update: 2021-11-14
The marketing authorization holder of this product should submit a supplementary application for the revision of the insert in accordance with the requirements for the revision of the insert sheet of Ginkgo Damo injection in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations.
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Novartis' potential "first-in-class" complement inhibitor reaches phase 2 clinical endpoint
Time of Update: 2021-11-14
Today, Novartis announced that its potential "first-in-class" oral factor B inhibitor iptacopan (LNP023) has reached its primary clinical endpoint in a phase 2 clinical trial for the treatment of patients with C3 glomerulopathy (C3G).
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Announcement of the State Drug Administration on 15 batches of drugs that do not meet the requirements (No. 49 of 2021)
Time of Update: 2021-11-14
were inspected by the Gansu Institute for Drug Control and were not in compliance with the regulations, and the non-compliant items were impurity; labeled as Hebei The 5 batches of Bupleurum (North Bupleurum) produced by Yuekang Zhide Pharmaceutical Co.
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Novavax applies for provisional approval of new crown vaccine in New Zealand
Time of Update: 2021-11-14
"Novavax has now completed the process of submitting NVX-CoV2373 (recombinant nanoparticle protein new coronary pneumonia vaccine candidate with Matrix-M™ adjuvant) to Medsafe for regulatory review .
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The National Medical Insurance Bureau issued the national procurement renewal document: no "only bargaining, no quantity"!
Time of Update: 2021-11-14
In addition, in response to previous penalties for winning bids for failing to supply the agreed procurement volume in accordance with the agreement, the "Notice" also made provisions on "strengthening credit and performance evaluation", "improving supporting policies", and "strengthening performance supervision".
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Announcement of the State Food and Drug Administration on the publication of the list of medical pharmacy professional publications that allow the publication of prescription drug advertisements (No. 64 of 2021)
Time of Update: 2021-11-14
According to the "Advertising Law of the People's Republic of China", the National Health Commission of the People's Republic of China agreed to include the "Journal of Alzheimer's Disease and Relate
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What is Pfizer still planning to return to the world's No. 1 mRNA vaccine?
Time of Update: 2021-11-14
In the financial report, Pfizer raised its full-year sales forecast for Comirnaty's new crown vaccine by 7% to approximately US$36 billion .
Pfizer also announced the latest developments in six key R&D pipeline products including the new crown vaccine, gene therapy pipeline, PDE4 inhibitor, TL1A inhibitor, IFN-β inhibitor and oral COVID-19 drugs .
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Announcement of the State Food and Drug Administration on Revising the Drug Insert for Alocillin Sodium for Injection (No. 108 of 2021)
Time of Update: 2021-11-14
The marketing authorization holders of the above-mentioned drugs shall be in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, in accordance with the requirements for the revision of the drug insert for azlocillin sodium for injection (see attachment), in December 2021 Report to the provincial drug supervision and administration department for the record 2 days ago .
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Announcement of the State Food and Drug Administration on the conversion of four drugs including Shufeng Jiedu capsules into over-the-counter drugs (No. 90 of 2021)
Time of Update: 2021-11-14
The list of varieties (Annex 1) and the template of non-prescription drug instructions (Annex 2) are released together .
The contents of the non-prescription drug inserts other than those specified in the template inserts shall be implemented in accordance with the original approval documents .
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Announcement of the State Food and Drug Administration on the conversion of four drugs including Shenqi Wuweizi Capsules into over-the-counter drugs (No. 100 of 2021)
Time of Update: 2021-11-14
The list of varieties (Annex 1) and the template of non-prescription drug instructions (Annex 2) are released together .
The contents of the non-prescription drug inserts other than those specified in the template inserts shall be implemented in accordance with the original approval documents .
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Tianjing Biological Announces New Chief Financial Officer and Chief Strategy Officer
Time of Update: 2021-11-14
Long Jiang served as the chief financial officer or senior vice president of finance in biomedical companies such as WuXi AppTec Group, WuXi MingMa, Zhenhe Technology, and Si Microbiology, and led a number of important positions.
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Announcement of the State Food and Drug Administration on the issuance of 3 supplementary inspection methods including the supplementary inspection method for the pseudo-ginsenoside F11 inspection item in Ginseng Yangrong Pills (202
Time of Update: 2021-11-14
According to the relevant provisions of the "Drug Administration Law of the People's Republic of China" and its implementation regulations, "Supplementary Inspection Method for the F11 Inspection Ite
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[2021 ASH] The clinical progress of Oribatinib, a new anti-drug-resistant leukemia drug, was selected as an oral report at the ASH annual meeting for the fourth time. A total of three studies of this product were selected
Time of Update: 2021-11-14
Oribatinib (HQP1351) is the key to the treatment of tyrosine kinase inhibitor (TKI)-resistant BCR-ABL1 T315I mutant chronic myelogenous leukemia (CML-CP and CML-AP) subjects The latest results of the phase II trial 3598 Poster display Trial in Progress: Phase 1b Bridging Study of the Pharmacokinetic (PK), Safety, and Efficacy of Orally Administered Olverembatinib (HQP1351) in Patients with Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph + ALL)
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Cumulative savings of about 250 billion yuan!
Time of Update: 2021-11-14
The implementation of centralized procurement has significantly reduced the prices of commonly used drugs for the treatment of common diseases such as high blood pressure, diabetes, hyperlipidemia, cancer, and mental diseases, with an average drop of more than 50%.
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Osaikang's second biological Class 1 new drug storms the tens of billions of ophthalmology market
Time of Update: 2021-11-14
Figure 1: The latest product information declared by OsaikonSource: CDE official websiteThe announcement mentioned that ASKG712 injection can block the VEGF/VEGFR signal and effectively control the formation of new blood vessels, while also inhibiting the Ang-2 signal to improve blood vessel stability and reduce retinal inflammation, and consolidate the therapeutic effect of anti-VEGF-A .
