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The regulation of traditional Chinese medicine formula granules continues to be stricter, and manufacturers will face major challenges
Time of Update: 2021-12-30
Recently, the National Health Commission and the State Administration of Traditional Chinese Medicine jointly issued the "Notice on Regulating the Clinical Use of TCM Granules in Medical Institutions" (hereinafter referred to as the "Notice") .
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In 2022, the wave of mergers and acquisitions of pharmaceutical companies is coming?
Time of Update: 2021-12-30
The purpose of continuous mergers and acquisitions by large pharmaceutical companies includes enhancing R&D pipelines, investing in blockbuster drugs under research or about to be launched, complementation of product portfolios and synergistic effects of scale, and so on .
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Simcere's CDK4/6 inhibitor Trirazil is planned to be included in the priority review
Time of Update: 2021-12-30
Screenshot source: CDE official websiteThe proposed indication for Trilaciclib injection is the prophylactic use of Trilaciclib in patients with extensive stage small cell lung cancer (ES-SCLC) receiving platinum-containing drugs combined with etoposide to reduce bone marrow suppression caused by chemotherapy The rate of occurrence .
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Domestic pharmaceutical companies have set off a "financing fever", and the development of the pharmaceutical and biological industry is being accelerated
Time of Update: 2021-12-30
According to incomplete statistics, the number of IPO pharmaceutical companies on the Science and Technology Innovation Board in the first half of the year has reached 23, with a total financing amount of over 18 billion yuan .
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my country's first new coronavirus neutralizing antibody combination therapy with independent intellectual property rights was approved
Time of Update: 2021-12-30
According to the relevant provisions of the " Drug Administration Law" and in accordance with the special drug approval procedures, the State Drug Administration will conduct emergency review and approval, and approve the combination of the above two drugs for the treatment of mild and common types with progression to severe (including hospitalization or death) Adults and adolescents (12-17 years old, weight ≥40kg) with high-risk factors, patients with new coronavirus infection (COVID-19) .
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Traditional Chinese medicine talents are popular, and various places have successively issued documents stating that they will cultivate professional talents
Time of Update: 2021-12-29
At the end of October, Shaanxi Province also issued the "Measures to Accelerate the Development of Traditional Chinese Medicine Characteristics", which clearly stated that it would consolidate the talent base for Chinese medicine .
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The competition among pharmaceutical companies has moved from R&D to commercialization
Time of Update: 2021-12-29
In August of this year, the recombinant humanized PD-L1 monoclonal antibody Envolimab injection, which was jointly cooperated by Corning Jerry/Sincere Pharmaceuticals/Side Pharmaceuticals, was approved for marketing.
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CDE releases 3 technical guidelines for anti-coronavirus drugs
Time of Update: 2021-12-29
On December 7, CDE issued the "Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-coronavirus Chemical Drugs (Trial)" and "Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-coronavirus Pneumonia Drugs (Trial)" The "Technical Guidelines for Non-clinical Research on Novel Coronavirus Neutralizing Antibody Drugs (Trial)" will come into effect on the date of issuance .
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Zai Lab Class 1 new drug ``Omacycline tosylate'' will be approved soon
Time of Update: 2021-12-29
On December 10, the official website of NMPA revealed that Zai Lab's new class 1 drug ZL-2401 (Omadacycline tosylate) has entered the "under review" stage and is expected to be approved in the near future .
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8 batches of substandard drugs were exposed!
Time of Update: 2021-12-29
On October 9 this year, the Zhejiang Provincial Food and Drug Administration issued the second phase of the 2021 drug quality announcement.
In addition to Zhejiang Province, looking back at this year, news about the unqualified sampling of Chinese herbal medicines also appeared in the notices of local drug administrations .
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NMPA commends relevant units for participating in the investigation and handling of three cases of unlicensed operation and sales of counterfeit medicines in Zhangzhou
Time of Update: 2021-12-29
2. Henan Provincial Drug Administration, together with Nanyang City Market Supervision Administration and Fangcheng County Market Supervision Administration, investigated and dealt with a case of illegal drug distribution by a drug dealer in Xuchang City, imposing fines, revoking the "Drug Business License", and confiscating the legal representative Punishment measures such as salary income and life-long prohibition of engaging in drug production and business activities, and the suspected criminal clues have been transferred to the public security organs for handling .
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The anti-tumor drug market is vast, and pharmaceutical companies are frequently cooperating to accelerate the development of new drugs
Time of Update: 2021-12-29
Coincidentally, on November 21, Hengrui Medicine also jointly announced with CStone Pharmaceuticals that the two parties have reached a strategic cooperation and exclusive license agreement in the Greater China region for the anti-CTLA-4 monoclonal antibody CS1002 .
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Innovative drugs are accelerating their advancement into medical insurance, and pharmaceutical companies will usher in new opportunities
Time of Update: 2021-12-29
This time, its smooth access to health insurance, will help improve China-made innovative pharmaceutical drugs accessibility and affordability, benefit more hepatitis B patients .
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Try new rules for online drug sales in many places first!
Time of Update: 2021-12-29
Among the requirements that social pharmacies should meet at least for the Internet retail drug quality management activities, Hubei also proposed to establish Internet sales drug quality and safety management, online pharmaceutical services, drug distribution, reporting and complaint handling, and drug recall management systems, and establish effective drugs The recall system ensures that drugs sold through the Internet are traceable and verifiable throughout the entire process .
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Study finds diabetes drug dapagliflozin may benefit patients with heart failure
Time of Update: 2021-12-29
Patients with heart failure and preserved ejection fraction (HFpEF) often have a heavier burden of symptoms and functional limitations, and their quality of life is also poor; by targeting abnormalities in cardiac metabolism, sodium-glucose cotransporter 2 (SGLT2) ) Inhibitors may be able to improve these barriers .
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Within a week, 19 new class 1 drugs were approved for clinical use!
Time of Update: 2021-12-29
It is worth noting that in addition to the large number of clinical approvals of Class 1 new drugs, more patients will be benefited, and industry insiders also said that judging from the large number of domestic new drugs approved this time, domestic innovation strength is actually improving .
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"Technical Guidelines for the Application of Biomarkers in the Clinical Research and Development of Anti-tumor Drugs" released
Time of Update: 2021-12-29
On December 7, CDE issued the "Technical Guidelines for the Application of Biomarkers in the Clinical Research and Development of Anti-tumor Drugs", which will be implemented from the date of issuance .
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New anti-tumor drug outbreak: more than 70 products have been approved for clinical use, and Hengrui and Junshi performed well
Time of Update: 2021-12-29
Since November, there have been more than 100 clinically approved new drugs in China, of which nearly seven have become anti-tumor drugs, involving pharmaceutical companies such as Hengrui and Junshi .
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The medical device market has a bright future and is facing many challenges
Time of Update: 2021-12-29
In general, since this year, under the continuous promotion of policies, the medical device industry is accelerating its development .
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Jiangsu Wuzhong Trimetazidine Hydrochloride Sustained-Release Tablets Obtained Drug Registration Certificate
Time of Update: 2021-12-29
In ischemic cells, lower oxygen consumption is required to obtain energy through glucose oxidation compared to the β-oxidation process .
Enhancing glucose oxidation can optimize the energy process of cells, thereby maintaining proper energy metabolism during ischemia .
