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    Home > Medical News > Medical World News > The 6th adaptive drug that can be applied for market during the clinical period of a specific drug of the Pharmaceutical Express Society will be approved

    The 6th adaptive drug that can be applied for market during the clinical period of a specific drug of the Pharmaceutical Express Society will be approved

    • Last Update: 2021-01-18
    • Source: Internet
    • Author: User
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    November 20, 2020 / Medical Information List: Specific drugs can be applied for market during the clinical period; Cablivi and other 7 drugs are included in the third batch of clinically in urgent need of new drugs abroad; the sixth adaptation of K drugs is approved on the way; Lilly Barrettinib combination therapy is awarded EUA; and the third RNAi drug is today approved by the European Union... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief Drug Can Apply for Conditional Approval for Listing during Clinical Period November 19, CDE's official website issued a notice on the Technical Guidelines for Conditional Drug Approval and Listing (Trial).
    the guidelines, drugs that meet two specific conditions during clinical trials may apply for conditional approval.
    notice, the document is effective from the date of publication.
    (CDE) Shanxi Province cancelled the personal account of urban and rural residents' medical insurance on November 19, Shanxi Provincial Health Insurance Bureau and other three departments issued "Shanxi Province urban and rural residents of basic medical insurance general outpatient co-ordination management measures notice."
    that by the end of 2020, the basic medical insurance accounts and outpatients of urban and rural residents will be abolished and the overall quota management of outpatient clinics will be fully carried out.
    (Shanxi Provincial Health Insurance Bureau and other three departments) Fuzhou to implement the "14 actions" to ensure the development of village medical treatment on November 18, Fuzhou Municipal People's Government issued "on the overall improvement of the village health clinic basic medical and public health services capacity of the implementation of the opinion", the implementation of "14 actions", including strengthening the village health clinic hardware and software construction, stability and optimization of the village doctor team, strengthen the village health clinic operation mechanism to ensure.
    (Fuzhou Municipal People's Government) grass-roots doctor title promotion has new rules recently, the Dingxi Municipal People's Government of Gansu Province issued the "Dingxi City Health series of professional and technical personnel level and promotion method (trial) program."
    Under the conditions related to meeting the required job title, when the unit does not have a place for promotion, it may first file a record within the unit, pay the relevant salary according to the salary level of the relevant rank, and wait for the promotion when there are available places.
    (Dingxi Municipal People's Government, Gansu Province) directed Chinese medicine practitioners can be applied for recruitment recently, Jinhua City, Zhejiang Province, Wuyi County Health Bureau and other four departments jointly issued the Wuyi County grass-roots targeted Chinese medicine practitioners training work implementation advice.
    training object to obtain the qualification of rural general practice assistant physician, and in the targeted community health service station (village health room) to work, can be included in the establishment of primary medical institutions through open recruitment.
    on the morning of November 19th, the venture capital firm SR One said it had completed the spin-off from parent company GlaxoSmithKline and completed the first independent fund raising of $500 million, which would be used to invest in innovative biotech companies.
    (Xinhua) -- Samsung Biologics will dissolve its generics joint venture with AstraZeneta Inc., which decided in September to suspend research and development activities at its joint venture, Archigen Biotech, and liquidate its assets, according to a quarterly report released this week by Samsung Bio.
    development of SAIT101, a biosynthic of Rituxan, has also been abolished.
    (Sina Pharmaceutical News) Kun Pharmaceutical Group appointed Ms. Yu Xiaoru as vice president of the company today, Kun Pharmaceutical Group announced that the company's 9th 34th board of directors considered and approved the "on the appointment of Ms. Zhai Xiaoru as vice president of the company", the company decided to appoint Ms. Zhai Xiaoru as vice president of the company, the term of office is the same as the nine board terms of office.
    (Sina Pharmaceutical News) Umoja completed the $53 million round of A-round financing, Umoja announced the completion of the $53 million round of A-round financing.
    Umaja is working to develop a new CAR-T therapy for cancer treatment.
    the new treatment could transform the patient's immune system, allowing the patient's immune system to directly recognize cancer cells.
    Pharmaceuticals was officially listed on the Hong Kong Stock Exchange today, and Deqi Pharmaceuticals officially landed on the Hong Kong Stock Exchange, and the bell-ringing ceremony was held on the same day.
    the company's share issue price was HK$18.08 per share, resulting in a net proceeds of about HK$2.636 billion.
    (Pharmaceutical Mission) 1 Pharmaceutical Network Q3 revenue increased 112.8% YoY Cumulative revenue in the first three quarters of 2019 1 Pharmaceutical Network Q3 recorded a single quarter of revenue, achieving net revenue of RMB2.36 billion, up 112.8% YoY;
    (American News Agency) De-Exhibition Health will change the owner recently, De-Exhibition Health issued a notice on the controlling shareholders signed the "Share Transfer Framework Agreement" and the proposed changes to the controlling rights.
    the company's actual controller will be changed to the Xinjiang SASAC if a formal agreement is finally signed and the delivery is completed.
    (Cypress Blue) Part 3 Drug Information CD30/CD16A Dual-Specific Temperant Antibody Combination K Drug Treatment R/R HL Better Than Monopharmaceutical Therapy Recently, Affimed corporation announced that the results of a clinical study evaluating AFM13's joint Merca East anti-PD-1 therapy for recurrence or refractic Hodgkin's lymphoma have been published in the Journal of Hematology.
    , AMF13 and Keytruda combined to obtain higher ORRs than Keytruda single-drug treatments, especially: CR doubled.
    (Sina Pharmaceutical News) Cablivi and other 7 drugs included in the third batch of clinical urgent need for new drugs abroad on November 19, CDE official website issued "on the release of the third batch of clinical urgent need for foreign new drugs list notice."
    In accordance with the Bulletin on The Clinical Urgent Need for Review and Approval of New Drugs Abroad (No. 79 of 2018), the State Drug Administration and the National Health and Safety Commission organized the relevant expert research and demonstration, selected the third batch of clinically urgent need for new drugs from abroad, including Cablivi and other 7 varieties.
    (Sina Pharmaceutical News) Lilly Barrettinib combination therapy approved by the FDA for emergency use of COVID-19 hospitalized patients November 19, Lilly and Incyte announced that the U.S. FDA issued Barrettini and Redsey Emergency Use Authorization (EUA) for emergency use of combination therapy for suspected or confirmed COVID-19 adults and children (2 years of age or older) hospitalized in need of auxiliary oxygen supply, invasive mechanical aeration, or ECMO.
    (Immediate Drug News) Aducanumab drug aducanumab market license application was accepted by the EMA on November 19, Biogen and Eisai announced that the European Medicines Agency has confirmed the acceptance of the Alzheimer's experimental treatment drug aducanumab market licensing application, and will be reviewed in accordance with the standard schedule.
    a third RNAi drug has been approved by the European Union today and Alnylam today announced that its RNAi therapy Oxlumo (lumasiran) has been approved by the European Union for the treatment of type 1 primary oxalic aciduria.
    is also the third RNAi therapy approved.
    (immediate drug news) Corda 6th adaptive disease was approved in the single-drug first-line treatment of head and neck squamous cell carcinoma November 18, Merca East PD-1 monoanti-anti-Paboli pearl mono-anti-injection new adaptive drug market application in The status of NMPA changed to "in the approval", which means that its single-drug first-line treatment of tumor expression PD-L1 metastatic or non-removable relapsed relapsed head and neck squamous cell carcinoma of the new adaptive disease is about to be approved in China, which is also its sixth in the country is about to be approved.
    (CPhI Pharmaceutical Online) step pharmaceutical benzodiacycline tablets obtained the drug registration certificate today, step pharmaceutical announced that the wholly-owned subsidiary Shaanxi step high recently received NMPA approved the issuance of the "drug registration certificate" on benzodiacycline chloride tablets.
    is mainly suitable for hypertension, chronic stable angina, vasoconvulsive angina and coronary heart disease confirmed by angiocardiosis.
    (Sina Medical News) Baiji Shenzhou Shishu single anti-in China approved to prevent solid tumor bone metastasis and other causes of SRE today, Baiji Shenzhou announced that NMPA has approved the shuddate anti-injection fluid for the prevention of solid tumor bone metastasis and multiple myeloma caused by bone-related events (SRE).
    the drug was developed by Amjin, which was authorized by Baiji Shenzhou in accordance with a global cancer strategy agreed earlier this year.
    (Immediate Drug News) Etonian Pharmaceuticals announces positive results from VASCEPA China Phase III clinical studies Today, Eton Pharmaceuticals announces that VASCEPA ® (Twenty Carbon Pentaenyl Ethyl Ethyl Capsules) at Chinese mainland The Phase III EDPC003R01 study for patients with high triglycerideemia (≥500mg/dL) was completed, reaching the main therapeutic endpoint defined in clinical trial scenarios and showing similar safety to placebos.
    (Pharmaceutical Rubik's Cube) first sound pharmaceutical industry introduced a class of 1 new drugs approved clinical CDE publicity shows that the first class of new drugs declared by the first sound pharmaceutical industry SIM1909-13 tablets obtained two clinical trials implied permission, intended to be developed for gingulation with high uric acidemia patients.
    SIM1909-13 tablet is a URT1 small molecule innovation drug developed by JW Pharmaceutical of Korea.
    September 2019, Synsheng Pharmaceuticals acquired a clinical development and commercialization interest in China.
    (Pharmaceutical Mission) Ruitron bio-heterogeneous immunocellular therapy products were approved clinically on November 19, Swisstron Bio announced that the company's allogeneic immunocellular therapy product RC1012 injection obtained an implied license for CDE clinical trials, to develop adaptive disorders for relapse difficult to treat acute myeloid leukemia.
    (Medical Mission) Loratinib reduced the risk of disease progression or death in patients with NSCLC by 72%, NEJM published the results of a midterm analysis of the third-generation ALC inhibitor Lorlatinib's phase 3 randomized trial CROWN for the first-line treatment of non-small cell lung cancer.
    in ALK re-scheduled NSCLC patients, Laratinib performed better on multiple efficacy indicators than the existing first-line standard treatment of cytodinib.
    (Medical New Perspective) NEJM: Immunotherapy is moving toward "curing" type 1 diabetes, according to a study published by NEJM.
    (Medical New View point)
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