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The growing number of FDA applications for complex generic drugs requires more review resources to be allocated
Time of Update: 2021-12-04
In fiscal year 2017, the sponsor submitted 1,306 ANDAs to the FDA, including approximately 177 applications for complex generic drugs .
In fiscal year 2019, the share of complex generic drug approvals increased to 12.
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Game model of centralized insulin procurement: consideration of quantity and price
Time of Update: 2021-12-04
Peak shaving and valley filling : Most or all of the basic volume is obtained for the low quotation, plus part of the quoted volume of the high quotation or unparticipated or unselected varieties; the high quotation is either eliminated or the quoted volume is allocated .
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Authoritative interpretation by experts: a reasonable choice of metformin dual oral hypoglycemic drugs
Time of Update: 2021-12-04
" Professor Xu Chun specifically pointed out that as a Chinese network Jinlida granules, an innovative drug under the guidance of disease theory, has conducted a large number of studies in the prevention and treatment of diabetes and has a significant effect .
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Research shows that real-world data is not yet ready to replace post-approval confirmatory testing
Time of Update: 2021-12-04
Joshua Wallach and co-authors of the Department of Environmental Health Sciences of the Yale School of Public Health stated in a health policy research letter [1] published on JAMA Network Open on November 9, 2021, “The results of this horizontal study show that in 2009 Among the 50 FDA-required post-approval confirmatory trials for therapeutic drugs that received accelerated approval between 2018 and 2018, none of them can use currently available claims and/or structured electronic health record data .
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A major overhaul is ushered in 14 years!
Time of Update: 2021-12-04
Background of the introduction of the new regulations on the management and use of Chinese medicines At the beginning of 2019, the State Food and Drug Administration officially launched the revision of the "Measures for the Supervision and Administration of Drug Sales" and organized a special drafting team.
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The 38th issue of the weekly financing report included 23 cases, with a total financing amount exceeding 3 billion yuan!
Time of Update: 2021-12-04
1. It was recently learned that Cornerstone Robotics, a leader in innovative surgical robotics technology, announced the completion of the B round of financing, with a total of 500 million yuan in this round of financing.
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Still fighting algorithms and computing power?
Time of Update: 2021-12-01
Ma Jian said that the application development of AI technology itself is undergoing phase changes from algorithms, computing power to data .
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In 2021H1, my country’s three major terminals and six major markets have drug sales of 839.3 billion yuan, a year-on-year increase of 8.8%
Time of Update: 2021-12-01
From the perspective of the sales distribution of the three major terminals that realize drug sales, public hospitals have the largest market share, accounting for 63.
4% in the first half of 2021; public primary medical terminal markets The share accounted for 9.
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Reindeer Medical's CT120 fully human dual-target product was approved by the U.S. FDA as an orphan drug
Time of Update: 2021-12-01
In a clinical study initiated by the investigator (registration number ChiCTR2000038641), 4 B-ALL subjects achieved complete remission after receiving CT120 treatment, with a CRR of 100%, and no occurrence of any grade 3 or above Adverse reactions of CRS, no adverse reactions of ICANS were observed .
Therefore, CT120 is expected to become an innovative treatment for relapsed/refractory B-ALL .
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[Focus] 74 million people’s experience in seeing a doctor, summed up this "hospital list"
Time of Update: 2021-12-01
The Health Industry Development Research Center of the Chinese Academy of Social Sciences, in conjunction with Good Doctor Online, researches the annual index of the integration and development of medical institutions and the Internet, and publishes the 2021 China Hospital Internet Influence Rankings, which is the sixth consecutive year that the list has been released .
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Why did the stock price of the leading company get the orphan drug identification?
Time of Update: 2021-12-01
Source: Zhongkang FIC Intelligence database Prior to this, Genxi Biosciences has announced the latest clinical research progress of GC012F in the treatment of relapsed/refractory multiple myeloma at a number of top international academic conferences .
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MNC "Slimming" is here again!
Time of Update: 2021-11-15
Another giant reported the news of spin-off or divestiture of the generic drug business, this time the protagonists are Novartis and Sandoz .
According to the financial report, Novartis's generic drug business (Sandoz) net sales were US$2.
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The main report of "Building China's Pharmaceutical Innovation Ecosystem (2021-2025)" was officially released to help build China's pharmaceutical innovation powerhouse
Time of Update: 2021-11-15
In response to the requirements of the times, the China Pharmaceutical Promotion Association and RDPAC started in early 2021 and organized and wrote 4 reports, focusing on "2015-2020 development review and future prospects", "promoting basic research, activating the source of innovation", and "multi-level medical care".
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Targeting the global pattern of CTLA-4 R&D, Chinese companies are in a favorable position
Time of Update: 2021-11-15
Figure 9 China's CTLA-4 product phase distribution (source: public information, Fengshuo Ventures; only statistics clearly indicate trials with specific indications; * is the top 10 cancer types in China) The differences in the development of CTLA-4 drugs between China and the United States have created three major opportunities for domestic companies.
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Liantuo Bio will be listed in the U.S., with a valuation of US$1.8 billion. Can you recreate the legend of Genting Xinyao's "License-in"?
Time of Update: 2021-11-15
Focus on "License-in" Liantuo Bio is a globalized, technology-driven biopharmaceutical company, focusing on License-in in China and other Asian markets, and is committed to solving unmet patient needs and promoting medical progress .
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Demand dividend continues to be released. Digital healthcare is ushering in the best era!
Time of Update: 2021-11-15
Digital medical content continues to develop along with technological advances, making medical equipment, medical network systems, and medical system-related services more intelligent, providing more efficient integrated services, and helping to improve the service capabilities of medical institutions .
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CDE priority review analysis in the first three quarters of 2021
Time of Update: 2021-11-15
3) Vaccines and innovative vaccines urgently needed for disease prevention and control; 4) Drugs included in the breakthrough therapeutic drug program; 5) Drugs that meet the conditions of approval; 6) The State Drug Administration stipulates other priority review and approval situations .
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Express｜To make tumor cells "nowhere to escape", Takeda announces the acquisition of γδT cell therapy platform
Time of Update: 2021-11-15
This acquisition expands Takeda’s combined pipeline of immuno-oncology and innate immune cell therapy to develop potential therapies for solid tumors and hematological malignancies .
" Reference materials: [1] Takeda to Acquire GammaDelta Therapeutics to Accelerate Development of Allogeneic γδT Cell Therapies Addressing Solid Tumors.
Retrieved October 27, 2021, from https:// -GammaDelta-Therapeutics-to-Accelerate-Development-of-Allogeneic-%CE%B3%CE%B4T-Cell-Therapies-Addressing-Solid-Tumors
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The line is coming, witnessing the industrialization of cell and gene therapy
Time of Update: 2021-11-15
The combination of cell and gene therapy companies + CTDMO enables R&D companies to maintain a relatively lightweight operation and management, and focus more on the development and innovation of core products, while large-scale testing and part of the production links can be handed over to more professional CTDMO partners to form industrialization advantages, improve efficiency, reduce costs, and improve patient accessibility .
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Trillions of new outlets!
Time of Update: 2021-11-15
Figure 2: 2011-2020 China's health insurance original premium income (unit: 100 million yuan) and growth rate changes Source: China Banking and Insurance Regulatory Commission, Firestone Creation From the perspective of commercial health insurance compensation expenditures, the annual compensation amount of insurance companies has increased from 36 billion yuan in 2011 to 292.
