Executives of two pharmaceutical companies have resigned from Russia's first new crown vaccine registration.

August 11, 2020 / Medical Information At a Glance: Roche releases new clinical data for etrolizumab UC Phase III Two maintenance treatments are not at an end; Daily fresh medicine news, speed reading society and you pay attention to! Part 1 policy briefing drug companies were reported twice: found out the fabrication of batch records, re-batch number 10, Jilin Provincial Drug Administration issued the "Administrative Penalty Decision" (Ji Pharmaceutical Supervision and Drug Administration Penalty No. 2020 YS1), will now summarize the main content as follows: Tonghua Sweyn 2 complaints reported to Jilin Provincial Drug Administration Director's mailbox, reported that: the pharmaceutical company in the process of producing drugs there are a number of violations.
inspection by the Drug Administration found that the company fabricated batch records for the solution of Yu'an tablets, gastric likang tablets and yanli anti-capsules, as well as changes to the gastric likang tablets, the production batch number of the anti-Yu'an tablets.
(Jilin Provincial Drug Administration) Part 2 Vice President and Deputy General Manager Zhao Chunsheng resigned fish leap medical 10 announced that the board of directors on August 10, 2020 received the company's vice president (deputy general manager) Zhao Chunsheng written resignation report, Zhao Chunsheng for personal reasons requested to resign as vice president (deputy general manager) of the company.
Zhao Chunsheng resigns, he will no longer hold any positions in the company.
(Fish Leap Medical Announcement) Tonghua Dongbao Deputy General Manager resigned on the 10th, Tonghua Dongbao issued a notice that the company's board of directors on August 10 received a written resignation report submitted by Deputy General Manager Han Fengjun - Han Fengjun for personal reasons, applied to resign as deputy general manager of the company.
, Han Fengjun will no longer hold any positions in the company.
(Xinhua) -- Bayer's $875 million acquisition of KaNDy Bayer and KaNDy jointly announced that Bayer will acquire the latter to expand its drug development pipeline in women's healthcare.
Under the terms of the agreement, Bayer will advance $425 million, potential milestone payments of up to $450 million, and subsequent potential additional triple-digit sales milestone payments, with the acquisition to be completed as soon as September 2020.
(Now) Dyne Therapeutics received an additional $115 million investment in Dyne Therapeutics to announce the completion of a new round of equity financing of $115 million.
, a company founded in 2018 and just completed a $50 million round of A financing in April 2019, focuses on developing targeted drug therapies for patients with severe muscle disease.
First Third Co., Ltd. and AstraZene C.K. have entered a clinical trial with AstraZenecom Inc. to evaluate the combined treatment of patients with advanced or metastasis non-small cell lung cancer with EGFR mutations in Patritumab deruxtecan and Tagrisso.
(Bio Valley) drug Ming-Juno and Lyell Immunopharma reached a partnership to develop step-by-step T-cell therapy on the 10th, Drug-Min-Juno announced a cooperation agreement with Lyell Immunopharma to develop and commercialize step-by-step T-cell therapy in China and Southeast Asian countries for liver cancer treatment.
, the two sides also hope to seek further cooperation opportunities in China in areas such as research, development and commercialization of new products.
(Pharma Mission) Part 3 Drug News Roche released new clinical data for etrolizumab UC Phase III before the end of the two maintenance treatments, Roche member Genentek released the top-line data from a series of Phase 3 clinical studies that studied the efficacy of the drug etrolizumab in patients with moderate to severe active ulcerative colitis.
four studies, two etrolizumabs reached the primary endpoint of patient remission as an induced treatment, and two studies evaluating etrolizumab as maintenance therapy failed to reach the primary endpoint, with no significant difference in the proportion of patients who received remission mainly from intraskin injections.
(Sina Pharmaceutical News) Seres released the positive results of the microbiome drug key study on the 10th local time, Seres became the first company to detail the microbiome drug key research positive results.
study, which looked at 182 patients who were repeatedly infected with Thyrobacteria bacteria, found that patients taking SER-109 capsules were significantly less likely to relapse.
specifically, nearly 90 percent of patients who took the drug after eight weeks of treatment did not develop a thyroid infection, while nearly 60 percent of those in the placebo group developed a recurrence of the infection.
(Sina Pharmaceutical News) Coagulant pathway inhibitor treatment COVID-19 showed strong efficacy Omeros recently announced the narsoplimab treatment of COVID-19 acute respiratory distress syndrome patients with a sympathetic drug results.
Narsoplimab is a monoclonal antibody that targets glycosin-binding coagulation-related serine protease-2, and the study involved six patients with ARDS COVID-19, all of them requiring mechanical aeration before treatment, and after treatment with narsoplimab, all patients recovered, survived and were discharged from the hospital.
(Xinhua) -- Russian President Vladimir Putin has announced that Russia's first new crown vaccine has been approved by the Ministry of Health and his daughter has taken the lead.
, Russia's deputy health minister, has previously said the first vaccine will be registered on August 12th and will be given priority to health care workers and the elderly.
(Sina Pharmaceutical News) and Huang Pharmaceuticals Plan submitted applications for Sovantinie's listing license and Huang Pharma announced today that it has received scientific advice from CHMP on the use of Sovantini for the treatment of patients with advanced neuroendocrine tumors.
based on CHMP's recommendations, and the SANET-ep and SANET-p studies that Yellow Pharma believes have been completed, as well as existing data on Sovantini's treatment of non-pancreatic and pancreatic NET patients in the United States, can be used as a basis for filing a listing license application.
, in view of the fact that no filing issues have been found, and Yellow Pharmaceuticals plans to submit a new drug listing application to the FDA in 2021 after filing a European listing permit application.
(Sina Pharmaceutical News) Gilead submitted to the FDA a new drug application for the treatment of COVID-19 Gilead announced that it has submitted to the FDA a new drug application for Veklury (remdesivir), a research antiviral drug used to treat COVID-19 patients.
Veklury is currently licensed to treat severe COVID-19 inpatients in the United States.
(Xinhua) -- The U.S. FDA has qualified paxalisib for rare pediatric diseases, Kazia announced, and the FDA has granted paxalisib the right to treat rare pediatric diseases of diffuse endogenetic bridge glioma.
is a rare and highly invasive malignant tumor in children, with a high rate of death due to a severe lack of effective treatment.
(Bio Valley) FDA granted human skin substitute StrataGraft priority review for the treatment of deep II burns Mallinckrodt recently announced that the FDA has accepted StrataGraft's biological product licensing application, a regenerative skin tissue therapy for the treatment of deep II burns in adult patients.
FDA has granted priority review of the application and has set a target date of February 2, 2021 for prescription drug user fees.
(Biogu) new class of sugar-lowering drug imeglimin filed for the world's first market application, Poxel SA announced that its partner, Family Friend Pharmaceuticals, has submitted a new application in Japan for a new oral sugar-lowering drug, imeglimin, to treat type 2 diabetes.
both sides expect imeglimin to go on sale in 2021 after approval.
(Bio Valley) to Ling Pharmaceutical Lianhua Qing plague capsules by The Kyrgyz food supplement registration certificate to Ling Pharmaceutical Lianhua Qing plague capsules by Kyrgyzstan food supplements registration certificate Toling Pharmaceuticals issued a notice that the company recently received the Kyrgyz Ministry of Health approved the issuance of food supplement registration certificate, approved the company's products Lianhua Qing plague capsules in line with Kyrgyzstan food supplement standards registration.
will be sold to residents as a food supplement through a network of pharmacies and store counters.
(Eling Pharmaceuticals Announcement) Today five new class 1 drugs approved clinical CDE latest publicity, a number of new class 1 drugs to obtain clinical trials implied license, the proposed development of adaptive diseases including tumors, non-alcoholic fatty hepatitis, diabetic retinal lesions, respectively, from Bayer, Novartis, Ganley Pharmaceuticals, Axindawei, Jesinta Inda.
(Pharmaceutical Mission) Kangfang BioPD-1/VEGF (AK112) was approved by NMPA Clinical Trials Kangfang Biofast announced that the company's independently developed dual-specific antibody PD-1/VEGF (AK112) was approved by the State Drug Administration (NMPA) for drug clinical trials, will be further developed in China for advanced solid tumor phase 1b clinical trials.
(Kangfang Biological Bulletin)