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Boehringer Ingelheim and Thoeris collaborate on new treatments for urea cycle disorders
Time of Update: 2021-12-09
Boehringer Ingelheim will start a new collaboration with Thoeris to advance the first-of-its-kind therapy for the treatment of urea cycle disorders (UCD), regardless of the underlying single-gene cause.
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CDE solicits opinions on relevant regulations on drug review timing management
Time of Update: 2021-12-09
According to the draft for comments, the six situations for the suspension of timing operations are: disapproval of publicity and dissent from the review conclusion; waiting for the company to reply and issue supplementary materials; waiting for an expert consultation meeting, etc.
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First-line treatment of NSCLC!
Time of Update: 2021-12-09
ArticleMedicine GuanlanOn November 1, Allis Pharmaceuticals announced that its third-generation EGFR-TKI drug Ivesa (Vometinib mesylate) is the first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitive EGFR mutations.
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TOP10 ophthalmic drugs exposed!
Time of Update: 2021-12-09
According to the latest data from Mi Nei. com, the sales of terminal ophthalmic drugs in public medical institutions in China in 2021H1 exceeded 5 billion yuan, a year-on-year increase of 29.
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FCN-342 Tablets, a subsidiary of Fosun Pharma Holding Group, Obtained Drug Clinical Trial Approval
Time of Update: 2021-12-09
The new drug is a URAT1 inhibitor independently developed by the company and is intended to be mainly used for the treatment of gout and hyperuricemia .
As of September 2021, the Group has invested approximately RMB 18 million in R&D for this new drug at this stage (unaudited) .
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Zhao Junning is appointed Deputy Director of the State Drug Administration
Time of Update: 2021-12-09
Among them, Zhao Junning was appointed as the deputy director of the State Drug Administration .
In October 2021, he was appointed Deputy Director of the State Drug Administration .
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Pay attention to the "fourth highest" high uric acid medication pattern inventory
Time of Update: 2021-12-09
. Market scale of anti-gout drugs in Shanghai hospital market from January 2020 to August 2021 (unit: ten thousand yuan)At present, anti-gout drugs mainly include five drugs: febuxostat, benzbromarone, Qingpeng ointment, allopurinol and colchicine .
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Soaring 973%!
Time of Update: 2021-12-09
Figure 1: The situation of products declared by Sichuan Guowei for the production of pharmaceuticalsSource: CED official websiteIn recent years, irritable bowel syndrome (IBS) is considered to be a global functional disease with the highest incidence.
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Soaring 20 times!
Time of Update: 2021-12-09
According to CCTV Financial News, Carzodopa sustained-release tablets have been out of stock on the market recently, and many patients have posted in "Parkinson's Bar" to buy drugs from their patients in order to seek medicine .
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Bayer joins hands with Jointown to empower self-care and continue to expand the accessibility of health products
Time of Update: 2021-12-09
Both parties agreed to expand the breadth and depth of existing cooperation, and deepen cooperation in areas such as enriching product categories, improving product accessibility, and carrying out self-health science education and publicity, so as to provide consumers with richer self-health solutions to meet diversified needs.
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Ji'ankang's core product for bile duct cancer drug obtained FDA fast track qualification
Time of Update: 2021-12-09
ArticleMedicine GuanlanOn October 27th, Yaojieankang announced that the US FDA has granted the company's core product TT-00420 fast track qualification for the treatment of cholangiocarcinoma (CCA) patients without standard treatment options .
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AMX0035 has submitted a new drug application to the FDA for the treatment of amyotrophic lateral sclerosis
Time of Update: 2021-12-09
A few days ago, Amylyx Pharmaceuticals announced that it has submitted a New Drug Application (NDA) for AMX0035 to the US FDA for the treatment of amyotrophic lateral sclerosis (ALS) .
Reference materials:[1] Amylyx Pharmaceuticals Submits New Drug Application (NDA) for AMX0035 for the Treatment of ALS.
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Novavax and SII are authorized for emergency use of vaccines in Indonesia
Time of Update: 2021-12-09
(NASDAQ: NVAX), a biotechnology company dedicated to the development and commercialization of next-generation vaccines for severe infectious diseases, and Serum Institute of India Private Limited (SII), the world’s largest vaccine manufacturer, announced today that the National Agency for Medicines and Food Control of the Republic of Indonesia (Badan Peng was Obat dan Makanan (Badan POM)) has granted Novavax the use of Matrix-M™ adjuvant Emergency Use Authorization (EUA) for the recombinant nanoparticle protein new coronary pneumonia vaccine .
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The first in China!
Time of Update: 2021-12-09
Article source: Medical Rubik's Cube InfoAuthor: Shi BeiOn November 1, the clinical application of the bispecific antibody HLX35 targeting EGFR and 4-1BB dual targets by Henlius was officially accepted by the State Food and Drug Administration .
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Boehringer Ingelheim launches new product Willine
Time of Update: 2021-12-09
Yangzhou, October 28, 2021/PRNewswire/ - Boehringer Ingelheim, a global leader in the field of animal health, announced the official listing of the first domestic vaccine to prevent Marek's disease an
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Shiyao Forces 14 Class 1 New Drugs Intensive Attack This Year
Time of Update: 2021-12-09
Author: Jun Chen Zuo ShiOn October 26, CSPC Zhongqi Pharmaceutical's clinical application for SYHX2001 tablets submitted as a new drug category 1 was accepted by the CDE, and the product was declared for clinical use in China for the first time .
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SINBON Pharmaceuticals Securities Affairs Representative Lin Hanlin resigns due to job adjustment
Time of Update: 2021-12-09
On October 25, SINBON Pharmaceutical issued an announcement stating that the company received a written resignation report from Mr.
Due to work adjustments, Mr.
After resigning as the representative of securities affairs, Mr.
Lin Hanlin is still working in the company .
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The 2021 "Nobel Prize in Pharmaceutical Industry" officially announced that these products are on the list!
Time of Update: 2021-12-09
Best Biotechnology Product Award: Oxbryta (voxelotor), Global Blood TherapeuticsOxbryta is the first FDA-approved innovative therapy that targets the hemoglobin polymerization process and represents an innovative mechanism of action for the treatment of sickle cell anemia (SCD) .
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Hengrui Medicine's new generation AR inhibitor listing application plans to be reviewed first!
Time of Update: 2021-12-09
Article source: Medical Rubik's Cube InfoAuthor: Shi BeiOn October 28, the CDE official website showed that the listing application of Hengrui SHR3680 tablets was planned to be included in the priority review and started to be publicized for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden .
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Suzhou Ruibo Biotechnology Co., Ltd. uses ArisGlobal's LifeSphere® MultiVigilance solution to improve its clinical trial data management
Time of Update: 2021-12-09
Ruibo Bio will use the Chinese and English versions of ArisGlobal's LifeSphere Multivigilance to manage its drug safety data and meet the regulatory requirements for its products to enter the clinical trial phase .