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    Home > Medical News > Medical World News > Milestone of "medical fast reading society"! Zebotinib, a Btk inhibitor in Baiji, was approved by FDA

    Milestone of "medical fast reading society"! Zebotinib, a Btk inhibitor in Baiji, was approved by FDA

    • Last Update: 2019-11-15
    • Source: Internet
    • Author: User
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    On November 15, the Department of system reform of the State Health Commission issued the notice of the leading group of the State Council on deepening the reform of the medical and health system on further promoting the experience of deepening the reform of the medical and health system in Fujian Province and Sanming City The document mentioned that in 2020, in accordance with the unified deployment of the state, national organizations should expand the scope of centralized procurement and use of drug varieties (Sina Medical News) On November 14, 111 group released the third quarter financial performance report The report shows that the net income of 111 group in the third quarter reached 1.11 billion yuan, a year-on-year increase of 123.2%; the revenue of the first three quarters has doubled year-on-year, reaching 2.604 billion yuan, a year-on-year increase of 112% (Sina Medical News) On November 14, Abbott announced that miles white would resign as CEO on March 31 next year and be replaced by another Abbott veteran Robert B Ford (medical representative) Arkuda therapeutics, a cutting-edge company, has completed a $44 million round a financing to push its in-process therapies to its first human trial It is developing a drug that can address the underlying causes of dementia, making it possible to prevent the disease (chuangjianhui) On November 14, 2019 local time in the United States, X-37, an artificial intelligence drug R & D company, announced the completion of round a financing of US $14.5 million This round of financing is led by DCVC bio, followed by alpha intelligence capital and hemi ventures (arterial network) On November 15, zebutini, a Btk inhibitor independently developed by Baiji Shenzhou, was approved by the US FDA to be put on the market for the treatment of patients with mantle cell lymphoma who had received at least one treatment before As a result, it has become the first anti-cancer new drug in China that has been independently developed by Chinese enterprises and approved by FDA, bringing "zero breakthrough" to the sea of China's original new drugs (Sina Medical News) On November 15, the approval status of the listing application of Baiji Shenzhou PD-1 (tirelizumab, acceptance No.: cxss1800019) was changed to "under approval", and it is expected to be approved for listing soon, with the indication of recurrent / refractory classic Hodgkin's lymphoma (CHL) (Insight database) Today, according to the interface news report, lovima, a new hepatitis B drug of Weicai, failed to enter the national health insurance catalog through negotiation in the recent health care negotiations (Insight database) On November 15, Jianyou Co., Ltd announced that it had recently received the approval document of drug supplement application approved and issued by the State Food and drug administration, which approved the company to increase 2 specifications (0.6ml: 6150iu, 0.3ml: 3075iu) of naltrexaparin calcium injection, issued the drug approval number, and accepted the conclusion that the product was bioequivalent with the original imported product of naltrexaparin calcium injection (meter net) Today, the FDA approved the launch of Shionogi's innovative antibiotic, cefiderocol, to treat patients over 18 years of age with complex urinary tract infections, including kidney infections caused by susceptible Gram-negative bacteria These patients lack or have no other treatment options (yaomingkant) Today, biomarin announced that vosoritide, a drug under development, has significantly improved the growth of children with achondroplasia in a phase 2 clinical trial Vosoritide increased the average patient's natural history by 9 cm over a 54 month study (yaomingkant) On November 14, amarin announced that the FDA expert advisory committee voted 16:0 to approve vascepa as a new indication for reducing cardiovascular risk In most cases, FDA will follow the decision of the expert advisory committee, so it is likely to make a decision on the approval of vascepa for marketing on December 28 (medicine cube) On November 14, CDE publicized a new batch of clinical tacit license list, and itacitinib, an inhibitor of Cinda biological Jak1, was approved for clinical use, indicating graft-versus-host disease This variety is one of the three new drugs authorized by Incyte in 2018 Previously, two new drugs, pemigatinib and parsaclisib, have been approved for clinical use in cholangiocarcinoma, recurrent / refractory follicular lymphoma and borderline lymphoma (Insight database) On November 12, EDT, the oral insulin innovative drug ormd-0801 jointly developed by Hefei Tianmai Biotechnology Development Co., Ltd and Israel oramde Pharmaceutical Co., Ltd released positive phase IIB clinical trial results According to the results of the trial, after taking insulin capsule once a day for 3 months, the blood sugar of the patients decreased significantly and the weight could be controlled In addition, the test results showed good hypoglycemic effect, but also showed excellent safety characteristics, no serious adverse events related to drugs, nor increased the frequency of hypoglycemic events (e drug manager) Recently, the FDA approved the priority review of AstraZeneca selumetinib for the treatment of children with neurofibromatosis, a type 1 neurological disease A final ruling is expected in the second quarter of 2020 The approval will cover patients who have developed a plexiform neurofibroma, a disease-related tumor that cannot be treated surgically (Sina Medical News) Recently, FDA's Advisory Committee on endocrine and Metabolic Drugs "rejected" the application of 2.5mg of SGLT2 inhibitor jardiance (empagliflozin) for type 1 diabetes with the result of 14:2 In the committee's view, the benefits of the drug do not outweigh its risks (Sina Medical News) According to nature, nonalcoholic steatohepatitis (NASH) has become the second most common cause of liver transplantation in the United States after chronic hepatitis C, and is expected to become the primary cause in 2020 As the developer of octalva, the only Nash drug to enter the regulatory review process, intercept is actively preparing for the upcoming potential commercial launch Jerry Durso, its chief operating officer, said last week that the company had made significant progress in preparing to launch the ocaliva treatment for NASH The company has initiated payer negotiations, formed an internal sales team, and is working with a contract sales team, which will provide the company with additional opportunities and flexibility (Sina Medical News) Recently, FDA issued a draft guideline for safety reporting of new drugs for clinical research (ind) in electronic format, requiring the sponsor to submit the serious and unexpected suspicious adverse event safety report of ind to FDA adverse event reporting system 24 months after the final version of the guideline is released (yaomingkant) Recently, Finch therapeutics announced that it will expand a cooperation agreement with Takeda The two companies will use finch's human first discovery platform to develop microbiological drugs targeting Crohn's disease (yaomingkant)
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