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U.S. FDA approves Nuzyra (Omacycline) for oral administration only
Time of Update: 2021-06-22
Recently, the FDA also approved Nuzyra's oral dosing regimen for the treatment of acute bacterial skin and skin tissue infections (ABSSSI) in adult patients .
The drug is a modern tetracycline antibiotic that is administered orally or intravenously once a day for the treatment of CABP and ABSSSI .
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Avenue's new drug application for non-opioid painkiller tramadol again rejected by the FDA
Time of Update: 2021-06-22
CompilationFan DongdongAccording to the detailed information of the complete response letter (CRL) issued a few days ago, the US Food and Drug Administration (FDA) once again refused to approve Avenue Therapeutics intravenous injection, the non-opioid painkiller tramadol .
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Zhejiang Pharmaceutical Vancomycin Hydrochloride for Injection Passed the Consistency Evaluation of Generic Drugs
Time of Update: 2021-06-22
Up to now, Zhejiang Medicine has invested about 6 million yuan in research and development expenses for the evaluation of the consistency of vancomycin hydrochloride for injection .
The company's 2020 sales revenue of vancomycin hydrochloride for injection is 193,354,400 yuan .
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Sincerity Pharmaceuticals: plans to spend 670 million yuan to build a marine biomedical manufacturing project
Time of Update: 2021-06-22
The main development of this project is marine biomedicine and traditional Chinese medicine.
7 billion yuan, product direction for the 1000 tons of fish oil EPA and super-medicine projects, the main products include fish oil, herbal extracts (Megan), Chinese medicine Pieces .
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The clinical advantage of Lepu Bio's differential PD-1 monoclonal antibody is beginning to show
Time of Update: 2021-06-22
The overall response rate ORR of Putrizumab (HX008) for second-line and above treatment of advanced melanoma was 18.
The overall response rate ORR of Putrizumab (HX008) in the treatment of dMMR solid tumors is 47.
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Betta Pharmaceuticals PD-1 batilimumab was approved for clinical use
Time of Update: 2021-06-22
Today, the CDE official website shows that the PD-1 monoclonal antibody Balstilimab (Balstilimab), a collaboration between Betta Pharmaceuticals and Agenus, has been approved for clinical use in advanced cervical cancer .
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US FDA approves Tembexa: the first smallpox antiviral drug for all ages
Time of Update: 2021-06-22
Chimerix recently announced that the US Food and Drug Administration (FDA) has approved Tembexa (brincidofovir) tablets and oral suspensions for the treatment of smallpox .
Original source:Chimerix Receives US Food and Drug Administration approval for TEMBEXA® (brincidofovir) for the Treatment of Smallpox
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Baiyunshan: Cefixime capsules passed the consistency evaluation of generic drugs
Time of Update: 2021-06-22
Baiyunshan Pharmaceutical General Factory received the "Drug Supplementary Application Approval Notice" issued by the National Medical Products Administration, cefixime capsules The quality and efficacy consistency evaluation of generic drugs has been passed .
At present, domestic manufacturers of cefixime capsules also include CSPC Ouyi Pharmaceutical Co.
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Trend: Not selected for drug purchases in bulk?
Time of Update: 2021-06-22
Moving forward, in March of this year, Fujian Province issued the official document of volume procurement, although it still followed the "Public medical institutions prioritize the use of selected varieties, and the remaining amount can be purchased in appropriate quantities and prices are suitable for other common names with the same common name.
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Long-term follow-up clinical guidelines plan to release CDE high-profile escort gene therapy products
Time of Update: 2021-06-22
The main purpose of the long-term follow-up of gene therapy products is to collect the delayed adverse reactions of subjects and understand the existence of gene therapy products in the body, so as to identify and reduce the long-term risk of patients receiving gene therapy products .
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118 medicines are transferred out of medical insurance
Time of Update: 2021-06-22
In recent times, many provinces have issued the provincial supplementary medical insurance digestion list:Qinghai: 98 drugs will be released on January 1, 2022According to the Qinghai Provincial Medical Insurance Bureau, in 2020, a total of 129 types of nationally monitored drugs and drugs that were not recruited and used by the Qinghai Provincial Drug Procurement Platform in the previous year will be transferred.
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State Food and Drug Administration: 16 batches of drugs produced by 14 companies do not meet the requirements
Time of Update: 2021-06-22
. The relevant situation is now announced as follows: After inspection by Anhui Food and Drug Inspection and Research Institute, it was labeled as 1 batch of compound clotrimazole cream produced by Hebei Jiuzheng Pharmaceutical Co.
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The latest data on the treatment of R/R CLL/SLL with Bcl-2 inhibitors by Ascent Pharmaceuticals: ORR reaches 80%
Time of Update: 2021-06-22
On June 7th, ASCO announced the oral report of the Bcl-2 inhibitor lisaftoclax (APG-2575) at the 57th American Society of Clinical Oncology (ASCO) annual meeting in the relapse/refractory (R/R) ) The
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The State Food and Drug Administration approves the marketing of Donafinil tosylate tablets
Time of Update: 2021-06-22
On June 9, the official website of the State Food and Drug Administration announced that the State Food and Drug Administration recently passed the priority review and approval procedure to approve the Class 1 innovative drug Donafenib Tosylate (trade name:) declared by Suzhou Zejing Biopharmaceutical Co.
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The new coronavirus causes the patient's immune system to attack their own tissues or organs
Time of Update: 2021-06-21
According to the official website of the University of Birmingham in the United Kingdom, a new study led by the school found that many COVID-19 patients have an immune response that attacks their own tissues or organs .
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Anti-AIDS drugs reduce the risk of comorbidities in HIV-infected patients
Time of Update: 2021-06-21
Professor Li Taisheng, director of the Department of Infectious Diseases of the Chinese Academy of Medical Sciences /Peking Union Medical College Hospital and chairman of the Infectious Diseases Branch of the Chinese Medical Association , said, “With the advancement of medicine, the continuous emergence of new drugs has extended the life expectancy of HIV-infected people, and AIDS has gradually become a kind of disease.
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New research: COVID-19 mutant strain poses a severe challenge to antibodies and vaccines
Time of Update: 2021-06-21
The research team pointed out that mutations in the spike protein of these mutant strains are likely to affect the protective effects of current antibody therapies and vaccines, as well as cross-species transmission to other host animals .
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Latest research: Immunity can be maintained for at least 1 year after being infected with the new crown
Time of Update: 2021-06-21
This time, scientists studied whether the immune response to the new coronavirus will produce long-lived memory plasma cells .
However, the researchers detected memory plasma cells that secrete antibodies specific to the spike protein encoded by the new coronavirus in 15 people about 7 months after infection .
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AstraZeneca vaccine adds potential side effects
Time of Update: 2021-06-21
According to a Reuters report on the 12th, the European Medicines Agency recently listed another rare blood disease, capillary leak syndrome (CLS), as a potential vaccine for AstraZeneca’s new crown vaccine.
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Beauty study: Children's new crown is as infectious as adults
Time of Update: 2021-06-21
According to a report by Singapore’s Lianhe Zaobao on the 13th, a community study in the United States showed that the viral load of children and adults with COVID- 19 symptoms are similar, which means that children infected with COVID- 19 are infectious.