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    Home > Active Ingredient News > Blood System > "Pharmaceutical Speed ​​Reading Society" Eli Lilly's Erbitux new dosing regimen was awarded the U.S. FDA...

    "Pharmaceutical Speed ​​Reading Society" Eli Lilly's Erbitux new dosing regimen was awarded the U.S. FDA...

    • Last Update: 2021-05-02
    • Source: Internet
    • Author: User
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    [April 9th, 2021 / Medical Information List] Zhao Jun, vice chairman and director of Osaikang, resigned; Eli Lilly’s Erbitux new drug regimen was approved by the US FDA; Hutchison Medicine received US$100 million in equity investment; Connoa Biotech submitted The IPO prospectus of the Hong Kong Stock Exchange.


    [April 9th, 2021 / List of Medical Information] Daily news about fresh medicines and medical news, Speed ​​Reading Club will pay attention to you together!

    Part1 Policy Brief

    Part1 policy briefing Part1 policy briefing

    Pharmaceutical company fined nearly 20,000 yuan for unqualified sulfur dioxide residue and content in decoction pieces

    Pharmaceutical company fined nearly 20,000 yuan for unqualified sulfur dioxide residue and content in decoction pieces

    On April 8, the Sichuan Provincial Food and Drug Administration and the Heilongjiang Provincial Food and Drug Administration announced two pieces of administrative penalty information respectively, and issued penalty announcements to two pharmaceutical companies that produce and sell inferior drugs.


    State Council: Individual accounts for employee medical insurance can be paid from 50% within the scope of the mutual aid policy for family members

    State Council: Individual accounts for employee medical insurance can be paid from 50% within the scope of the mutual aid policy for family members

    On April 7th, at the executive meeting of the State Council, the measures to establish and improve the mutual assistance mechanism of basic medical insurance for outpatients for employees were determined, and some outpatient clinics with chronic and special diseases, frequently-occurring diseases and common diseases, which are harmful to health and burdened with heavy costs, were gradually removed.


    The Hong Kong Special Administrative Region Government decides that AstraZeneca vaccine will not be supplied to Hong Kong this year

    The Hong Kong Special Administrative Region Government decides that AstraZeneca vaccine will not be supplied to Hong Kong this year

    On April 9, the Director of the Food and Health Bureau of the Hong Kong Special Administrative Region Government, Chen Zhaoshi, attended the Legislative Council meeting on the 9th and stated that the Special Administrative Region Government is concerned about reports of AstraZeneca vaccines in other places.


    Part2 Observation

    Part2 Sankei Observation Part2 Sankei Observation

    Yahong Pharmaceutical Appoints Dr.


    Yahong Pharmaceutical Appoints Dr.


    Zhao Jun, vice chairman and director of Osaikang, resigns

    Zhao Jun, vice chairman and director of Osaikang, resigns

    On the evening of the 8th, Osaikang issued an announcement stating that the board of directors had recently received a written resignation report from the company’s director, Mr.


    Hutchison Medical Receives US$100 Million Equity Investment

    Hutchison Medical Receives US$100 Million Equity Investment

    On April 8, Hutchison Pharma announced that it had reached a final agreement with Baring Asia Investment Fund to issue 100 million US dollars of new shares to Baring Asia’s affiliated funds through private placement, at an issue price of US$30.


    Connoa Bio submitted the IPO prospectus of the Hong Kong Stock Exchange

    Connoa Bio submitted the IPO prospectus of the Hong Kong Stock Exchange

    On the evening of April 8, the Hong Kong Stock Exchange disclosed the IPO prospectus of Connoa Bio, and the stock underwriters were foreign investment banks Morgan Stanley, China International Capital Corporation and Huatai International.


    Tengshengbo Pharmaceutical submitted the HKEx IPO prospectus to complete US$150 million in Series C financing

    Tengshengbo Pharmaceutical submitted the HKEx IPO prospectus to complete US$150 million in Series C financing

    On the evening of the 8th, the Hong Kong Stock Exchange disclosed the IPO prospectus of Tengsheng Biopharmaceuticals, and the stock underwriters were foreign investment banks Morgan Stanley and UBS.


    Part3 Medicine News

    Part3 Medicine News Part3 Medicine News

    Bristol-Myers Squibb and Merck announced the positive results of two major immunotherapies

    Bristol-Myers Squibb and Merck announced the positive results of two major immunotherapies

    Today, Bristol-Myers Squibb announced that its PD-1 inhibitor Opdivo, combined with chemotherapy or chemotherapy + anti-CTLA-4 monoclonal antibody Yervoy, is used as a first-line therapy in the treatment of patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.


    Oxbryta, the first treatment for sickle cell disease, announces latest research results

    Oxbryta, the first treatment for sickle cell disease, announces latest research results

    GBT recently evaluated Oxbryta's treatment for patients with sickle cell disease in patients with hemolytic anemia.


    Abbott's TriClip G4 tricuspid valve repair system obtains EU CE certification

    Abbott's TriClip G4 tricuspid valve repair system obtains EU CE certification

    A few days ago, Abbott’s latest generation of upgraded minimally invasive transcatheter tricuspid valve repair system TriClip G4 has obtained CE mark approval from European regulatory agencies to help prevent blood leakage from the patient’s heart tricuspid valve.


    Haohaishengke: Injection molding and astigmatism intraocular lens products obtained EU CE certification

    Haohaishengke: Injection molding and astigmatism intraocular lens products obtained EU CE certification

    On April 9th, Haohaishengke announced that the company's holding subsidiary, Henan Semix Biotechnology Co.


    Merck/Eisai’s “Immunity + Targeting” combination submits its first application in Japan

    Merck/Eisai’s “Immunity + Targeting” combination submits its first application in Japan

    Eisai and its partner Merck recently announced that they have submitted an application in Japan to combine the oral multi-receptor tyrosine kinase inhibitor Lenvima with the anti-PD-1 therapy Keytruda for the treatment of patients with advanced renal cell carcinoma.


    First-line treatment of head and neck cancer LAG-3 therapy obtains FDA fast track qualification

    First-line treatment of head and neck cancer LAG-3 therapy obtains FDA fast track qualification

    Today, Immutep announced that the US FDA has granted the company’s candidate therapy eftilagimod alpha fast track qualification as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma.


    The world's first COVID-19 dried blood spot detection method receives FDA emergency use privilege

    The world's first COVID-19 dried blood spot detection method receives FDA emergency use privilege

    Recently, the FDA announced that it has granted emergency use authorization for Symbiotica's self-developed product "COVID-19 Optional Antibody Test System".
    This is the world's first home-use COVID-19 antibody finger dry blood spot test that has been granted EUA.
    (Bio Valley)

    Eli Lilly's Erbitux new dosing regimen is approved by the U.
    S.
    FDA

    Eli Lilly's Erbitux new dosing regimen is approved by the U.
    S.
    FDA

    Recently, the US FDA approved a new dosage regimen of Eli Lilly’s targeted anticancer drug Erbitux: 500mg/m2 as a 120-minute intravenous infusion, once every 2 weeks, for the treatment of K-Ras wild-type, EGFR-positive metastasis Colorectal cancer and squamous cell carcinoma of the head and neck.
    (Sina Pharmaceutical News)

    CStone's new indications for RET inhibitors are planned to be included in priority review

    CStone's new indications for RET inhibitors are planned to be included in priority review

    According to the latest announcement by the Drug Evaluation Center of the National Medical Products Administration, the new indication application of CStone's RET inhibitor pratinib capsule has been included in the proposed priority review on April 8.
    The proposed indication is RET that meets specific conditions.
    Patients with mutant medullary thyroid cancer and patients with RET fusion-positive thyroid cancer.
    (Medicine Guanlan)

    Kangfang Bio-IL-4R monoclonal antibody was approved for clinical use

    Kangfang Bio-IL-4R monoclonal antibody was approved for clinical use

    On April 8, the CDE official website showed that Kangfang Biologics Class 1 new drug AK120 injection was approved for clinical use, and the indication is moderate to severe atopic dermatitis.
    This is the first time the drug has been approved for clinical use in China.
    The drug is currently approved by the FDA for the treatment of moderate to severe atopic dermatitis, moderate to severe asthma and chronic rhinitis.
    (Sina Pharmaceutical News)

    BeiGene TIGIT monoclonal antibody BGB-A1217 injection was approved for clinical use

    BeiGene TIGIT monoclonal antibody BGB-A1217 injection was approved for clinical use

    On April 9, the official website of CDE showed that BeiGene TIGIT monoclonal antibody BGB-A1217 injection was approved for clinical use, and the indication was advanced solid tumors.
    It is reported that BGB-A1217 is a TIGIT monoclonal antibody developed by BeiGene.
    This target inhibits T cell/NK cell-mediated tumor immune activation and belongs to an immune checkpoint.
    (Sina Pharmaceutical News)

    Shanghai Pharmaceuticals: Aripiprazole passed the consistency evaluation of generic drugs

    Shanghai Pharmaceuticals: Aripiprazole passed the consistency evaluation of generic drugs

    On the 9th, Shanghai Pharmaceuticals issued an announcement that Shanghai Pharmaceutical Zhongxi, a subsidiary of Shanghai Pharmaceuticals, recently received the "Approval Notice for Supplementary Drug Application" issued by the State Food and Drug Administration on aripiprazole tablets and aripiprazole capsules.
    Consistency evaluation.
    It is reported that both drugs are used to treat schizophrenia.
    (Shanghai Pharmaceutical Bulletin)

    Hengrui Medicine: Cisatracurium Benzene Sulfonate Injection Passed the Consistency Evaluation of Generic Drugs

    Hengrui Medicine: Cisatracurium Benzene Sulfonate Injection Passed the Consistency Evaluation of Generic Drugs

    On April 9, Hengrui Pharmaceuticals announced that the company has recently received the "Drug Supplementary Application Approval Notice" for cisatracurium besylate injection approved and issued by the National Medical Products Administration.
    The injection passed the quality and efficacy consistency evaluation of generic drugs.
    Cisatracurium benzenesulfonate is a neuromuscular blocker, suitable for surgery and other operations and intensive care treatment.
    (Announcement of Hengrui Medicine)

    Pfizer and Celcuity reach cooperation

    Pfizer and Celcuity reach cooperation

    On April 8, according to foreign media reports, cell analysis company Celcuity announced a global license agreement with Pfizer.
    Pfizer will grant the exclusive rights of gedatolisib to Celcuity.
    Gedatolisib is in clinical development for the treatment of patients with ER+/HER2-negative advanced or metastatic breast cancer.
    (Sina Pharmaceutical News)

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