The end of technical review of PD-1 tirelizumab in Baiji Shenzhou of "medical fast reading society" will be approved soon

|China CDC: plague is preventable and treatable Beijing citizens don't have to worry too much about the risk of plague infection On November 13, the Chinese Center for Disease Control and prevention announced that Beijing is not the plague focus, there is no plague fungus in the natural environment, and there is no plague fungus in mice, and the citizens have no chance to infect through contacting animals such as rats The risk of further spread of the epidemic is extremely low Citizens can work, live and go to medical institutions without worrying about the risk of infection (Sina Medical News) On November 12, according to Qilu Evening News, the Shandong provincial government held a standing meeting on November 11 to review and approve the guidance on canceling the medical consumables markup of public medical institutions and adjusting the price of medical services, and comprehensively cancel the medical consumables markup of all kinds of public medical institutions at all levels in the Province (cypress blue instrument) On November 13, Baiji Shenzhou announced its recent business highlights, expected milestones and financial results for the third quarter of 2019 Revenue for the third quarter ended September 30, 2019 was $50.14 million, with a net loss of $307.36 million (Sina Medical News) |Diabetes drugs face a big bargain On November 13, Tonghua Dongbao dived over 6% in the afternoon On the news, the medical insurance negotiation was carried out in different disease areas, and the diabetes medicine entering the medical insurance would face a big price cut (AP) |The end of technical review of Baiji Shenzhou PD-1 tirelizumab is about to be approved On November 13, it was learned that CDE had completed the technical review of the registration application of Baiji Shenzhou PD-1 for raleizumab, and had submitted it to the State Food and Drug Administration for approval on November 13 The conclusion of the technical review of varieties was "production approval" According to the review and approval process, after the technical review, tirelizumab will enter the next stage of document preparation and the center's review and issuance, which means that tirelizumab has entered the final stage of administrative approval, and the approval for listing is imminent (AP) On November 13, CDE official website showed that telacep for injection, a new class 1 drug of systemic lupus erythematosus independently developed by Rongchang biology, had been put on the market (medicine cube) On November 13, the approval status of the anti-tumor class 1 new drug "flumatinib" (acceptance No.: cxhs1800017) independently developed by hausen was changed to "under approval" in China After a round of supplementary data, on-site verification of clinical trials and on-site verification of production, insight predicted that the drug would be approved for listing in the near future (Insight database) According to the latest news of sina medicine, on November 13, Pfizer and mylan announced the merger of viatris (pronounced "VI ǝ - Tr ī s") The deal is expected to be completed by mid-2020, when it will appear under the name viatris (Sina Medical News) Today, kadmon announced that its in-depth oral selective Rock2 inhibitor kd025 for the treatment of chronic graft-versus-host disease (cGVHD) reached the primary end point of overall remission rate in the mid-term analysis of Rockstar, a key trial (yaomingkant) Today, Lilly announced that its IL-17 inhibitor taltz (ixekizumab) has reached the primary end point and all key secondary end points in two clinical trials for patients with active psoriatic arthritis and patients with non radioactive axial arthritis, further confirming the long-term effectiveness and safety of taltz (yaomingkant) On November 12, step pharmaceutical announced that Qionglai Tianyin Pharmaceutical Co., Ltd., a holding subsidiary, had recently obtained the GMP certificate issued by Sichuan drug administration The scope of certification: tablet, granule, hard capsule, syrup, mixture (including oral liquid) (including pretreatment extraction of traditional Chinese Medicine), oral solution (including extraction) (Sina Medical News) Recently, Pfizer announced the results of the key phase III clinical study a3921104 of xeljanz (tofacitinib) in the treatment of patients under 2-18 years old with idiopathic arthritis at the American Society of Rheumatology / Association of rheumatologists 2019 annual meeting in Atlanta The data showed that, compared with placebo, xeljanz treatment significantly reduced the incidence of disease flares, delayed the occurrence of flares, improved disease signs / symptoms and physical functions, and had continuous clinical significance in disease activity The safety was consistent with that of adult patients with rheumatoid arthritis (Sina Medical News) According to La Montagne, French media, on November 12, MSD chibret Mirabel, a production and research base located in Liyong, France, announced an important enterprise restructuring and transformation project in the morning of the same day MSD chibret Mirabel will cut more than 1 / 3 of its staff and face the possibility of overall sale At the end of October, MSD has issued a wave of layoffs notice, and will lay off nearly 500 sales and headquarters business teams in the United States early next year (Sina Medical News) Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, recently released important new analysis results of milestone III credence study, showing that the SGLT2 inhibitor, invokana (canagliflozin), consistently reduces the risk of renal and cardiovascular events in patients with different renal function levels or estimated glomerular filtration rate This analysis shows that invokana provides strong and consistent security and effectiveness at the EGFR level of all tests (Biovalley)