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The GD2 antibody new drug market application introduced by Saisheng Pharmaceutical is planned to be included in the priority review
Time of Update: 2021-09-13
The latest announcement from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China shows that the marketing application of Naxitumumab injection declared by SciClone Pharmaceuticals has been included in the proposed priority review, and it is planned to be developed for the treatment of relapse Or patients with refractory high-risk neuroblastoma .
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Hengrui Medicine's second-generation AR antagonist plans to be included in breakthrough treatment products
Time of Update: 2021-09-13
Text|Pharmaceutical Mission HillsOn August 26, the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China announced that Hengrui Medicine's new generation of AR antagonist SHR3680 was included in the proposed breakthrough therapy, and it was planned to develop metastatic hormone sensitivity for the treatment of high tumor burden.
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The National Medical Insurance Administration issued a list of public service items for centralized procurement of medicines and medical consumables
Time of Update: 2021-09-13
Attachment: List of public service items for centralized procurement of medicines and medical consumables National Medical Security Administration Medical Price and Bidding Procurement Guidance Center August 25, 2021 Medical Network, August 31.
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Shaanxi pharmaceutical company wins over $7 billion star drug
Time of Update: 2021-09-13
On August 16, the official website of the State Food and Drug Administration showed that Shaanxi Buchang High-tech Pharmaceuticals was approved for production of rivaroxaban tablets for generic type 4 applications and deemed to have been reviewed, becoming the company’s first approved antithrombotic drug.
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Many chain pharmacies sell their certificates and delist
Time of Update: 2021-09-13
(Picture information: intercepted to the official website of Inner Mongolia Drug Administration)According to the company's information, Bayannaoer Huifeng National Pharmaceutical Pharmacy Chain Co.
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271 drugs compete for the new version of the medical insurance catalog: before 2016, the opportunities for listed drugs are still active
Time of Update: 2021-09-13
The 2020 national medical insurance drug catalog adjustment has given these provinces an opportunity to supplement the catalog products-"Condition 7: Before December 31, 2019, enter 5 or more drugs in the latest provincial basic medical insurance drug catalog .
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Prospects of drug patent links: Who will be the first person to eat crabs?
Time of Update: 2021-09-13
Article 11 of the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" stipulates that "the first chemical generic drug that successfully challenged the patent and was approved for marketing shall be granted a period of market exclusivity .
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46 drug registration certificates including Lincomycin Hydrochloride Capsules were cancelled
Time of Update: 2021-09-13
Medical Network, September 1 News On August 27, the State Food and Drug Administration issued an announcement on the cancellation of registration certificates for 46 drugs including Lincomycin Hydrochloride Capsules (No.
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Administrative Measures for the Registration and Filing of Medical Devices and In Vitro Diagnostic Reagents
Time of Update: 2021-09-13
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Repeatedly defeated!
Time of Update: 2021-09-13
Or after patients with metastatic biliary tract cancer (BTC) are unlikely to reach the primary end point of overall survival (OS), Merck said it will stop the phase 2 INTR@PID BTC 055 trial of this therapy .
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Huahai Pharmaceuticals Memantine Hydrochloride Tablets Obtained Drug Registration Certificate
Time of Update: 2021-09-13
On August 31, Huahai Pharmaceutical issued an announcement stating that the company had recently received a "drug registration certificate" for memantine hydrochloride tablets approved and issued by the National Medical Products Administration for the treatment of moderate to severe Alzheimer's dementia .
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Read the link system of Chinese and foreign drug patents in one article
Time of Update: 2021-09-13
And the drug patent term compensation system provides a reference to help us continuously improve the relevant laws and regulations of drug intellectual property rights, further encourage China's generic drug companies to participate in competition, and increase China's enthusiasm for innovative drug research and development .
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confusing!
Time of Update: 2021-09-13
But now, investors have not ushered in the significant progress of the Sri Lankan microbial mRNA vaccine project (still in the clinical trial stage, and the time to market for the product cannot be predicted), but has waited for the announcement of Tibet Pharmaceuticals to change the way of cooperation with Sri Lanka .
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Otsuka Pharmaceutical's Rexulti orally disintegrating tablet is approved for marketing in Japan to treat schizophrenia
Time of Update: 2021-09-13
The results showed that the study did not meet the primary endpoint: at a predefined time point, there was no statistically significant separation between brexpiprazole and placebo in the change of the BPD Zanarini score scale from baseline .
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Junshi Biology JS014 Injection Obtained Drug Clinical Trial Approval Notice
Time of Update: 2021-09-13
The active ingredient of JS014 injection is recombinant interleukin 21-anti-human serum albumin (HSA) nanobody fusion protein.
The half-life of IL-21 is significantly prolonged by fusion of anti-HSA nanobody .
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Large numbers of medical representatives are becoming more and more difficult
Time of Update: 2021-09-13
The filing system positions the work of medical representatives as academic promotion, requiring medical representatives to no longer undertake sales tasks, and at the same time not to carry out in-hospital promotion activities without permission .
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Eli Lilly's RET inhibitor Selpercatinib capsule plans to be included in priority review
Time of Update: 2021-09-13
On August 26, the latest announcement on the CDE official website showed that Eli Lilly’s RET inhibitor Selpercatinib capsules are planned to be included in the priority review, which is suitable for
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The Gansu Provincial Food and Drug Administration issued several measures to promote the inheritance, innovation and development of traditional Chinese medicine
Time of Update: 2021-09-13
Provided by the national Chinese herbal medicine production enterprises, continuously strengthen the quality and safety supervision of the whole process from planting to use, improve the quality of Chinese herbal medicines, and promote the high-quality development of the Chinese medicine industry .
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How to deal with the national procurement rules for the centralized procurement of Chinese patent medicines?
Time of Update: 2021-09-12
Unlike generic drugs, price reduction will not be the first choice, but to further promote the supply-side reform of Chinese patent medicine companies through national procurement, promote the survival of the fittest by related companies, further concentrate production capacity, and improve product quality; the second is to reduce prices .
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Sufficient supply of selected products in centralized procurement of coronary stents by national organizations
Time of Update: 2021-09-12
Xinhua News Agency, Beijing, September 6 (Reporter Peng Yunjia) According to the latest news from the National Organization's Joint Purchasing Office for High-Value Medical Consumables, the overall supply of selected coronary stents is stable, and the overall supply of various types of stents exceeds the procurement demand .