echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > [King of a week] there are many rumors in the pharmaceutical industry. Is food and drug regulation going to be dismantled? Will AI overturn the industry?

    [King of a week] there are many rumors in the pharmaceutical industry. Is food and drug regulation going to be dismantled? Will AI overturn the industry?

    • Last Update: 2018-01-22
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Listen to the voice of the forefront of medicine food and drug regulatory reform, separate, split or merge? Southern Weekend reporter article "food and drug regulatory reform, single row, split or merger?"? 》Mentioned that there are various signs that in 2018, the top-level food and drug regulatory system may usher in a new round of reform First, a widespread saying came from within the industry and commerce system that "the State Council will integrate the functions of industry and commerce, quality supervision and food and drug departments, and establish an institution similar to the General Administration of market supervision." In the food and drug system, the news of "three bureaus in one" began to spread, but the "version" is slightly different - the drugs and medical devices will be under the management of the national health and Family Planning Commission, and the food will be under the supervision of the large market In this regard, the health system's personnel acknowledged that "medicine is not separate from each other" Compared with the eve of the previous reform, this adjustment is particularly low-key It is said that relevant ministries and commissions, including industry and commerce, quality inspection, and food and drug, have not participated in the scheme demonstration of this institutional reform The institutional reform plan is operated by the deep reform group of the Central Committee and is in a state of strict confidentiality, which does not rule out a substantial adjustment of the final published plan However, "after the second plenary session of the 19th Central Committee in January, the reform plan may become clear." A person from the State Food and Drug Administration said privately with a Southern Weekend reporter AI is subverting today's healthcare industry, IBM Watson spokesman di Sanzo said at this year's J.P Morgan Healthcare Conference: through the upgrading of IBM Watson AI program, it will ignite changes in the field of healthcare and health in four aspects: medical management, accelerating new drug research and development, determining the best treatment plan for cancer, clinical trials and patient matching For example, in the aspect of the matching between clinical trials and patients, through the IBM clinical trial matching (CTM) system, the entry criteria of artificial comparative clinical trials and the data information of patients' disease diagnosis and treatment are reduced Instead, the AI system is used to read all relevant data and automatically achieve the best match of patients with clinical trial requirements Four trends of the development of the pharmaceutical industry in 2018 China industry daily published an analysis article entitled "the task of pharmaceutical industry innovation is still arduous in 2018" With regard to the development of pharmaceutical industry in 2018, the paper summarizes four trends: production continues to maintain high-speed growth, and benefit indicators continue to pick up slightly; enterprise innovation and research and development are unprecedented active, and industry reshuffle continues to intensify; enterprise research, production and marketing cost pressure increases, and market and The policy affects the fluctuation of drug supply; the task of supply side structural reform is arduous, and the promotion of domestic medical devices is still difficult Experts of the "thousand talents plan" reported that the papers of "Yangtze River scholars" of Wuhan University were suspected of counterfeiting Recently, some people reported that Li Hongliang, a professor of Wuhan University, published four articles in nature medicine with an impact factor of 30 in 2017, two of which were suspected of counterfeiting The suspected points of counterfeiting include: insufficient monkey test cycle and insufficient number of key experimental monkeys At present, Wuhan University has launched the investigation procedure, and the investigation report should be available before the end of this semester, but the progress of the matter has not been disclosed According to the information on the official website of Wuhan University, Li Hongliang is currently the dean of the school of basic medicine, the director of the animal experimental center / absl-iii of Wuhan University, the director of the Institute of model animals of Wuhan University, the deputy director of the Institute of cardiovascular diseases of Wuhan University, and the director of the medical science research center of Central South Hospital He is also the winner of the national fund for Distinguished Young Scholars, the distinguished professor of "Yangtze River scholars" of the Ministry of education, the leader of science and technology innovation of young and middle-aged people of the Ministry of science and technology, and the leader of the national "ten thousand talents plan" 25 billion 700 million! Will the Chinese consortium acquire Johnson & Johnson diabetes? Recently, according to Reuters, Johnson & Johnson is seeking to sell diabetes care businesses including Lifescan, animas and Calibra, with a total transaction value of $4 billion (25.7 billion yuan) Potential buyers include a consortium of sannuobi and China construction investment, according to people involved At present, the consortium has hired a consultant to participate in the bidding On January 18, the General Administration issued the measures for the administration of the disclosure of drug review and approval information (Draft for comments) and solicited public opinions and suggestions after reading the measures for the administration of the disclosure of drug review and approval information (Draft for comments) on the major event of CFDA CDE Relevant individuals and individuals are requested to give feedback by email before February 21, 2018 This time, the main contents of drug review and approval information disclosure include drug registration application acceptance information, review and approval process information, review and approval result information and other review and approval information CFDA: these five monographs can publish advertisements for prescription drugs Recently, the General Administration announced that five professional medical and Pharmaceutical Journals, namely Journal of Neurology and neurorehabilitation, Journal of orthopedic clinical and research, Chinese drug evaluation, Chinese Journal of clinical nutrition, and Chinese exploration of rational drug use, can publish advertisements for prescription drugs Drug audit center moved! Since January 22, 2018, the office location of the drug Audit Center has been moved to No 128 Jianguo Road, Chaoyang District, Beijing, and the site or mailing submission / official documents have been changed to this address In addition, the website of the center will stop operation on January 20, 2018 and resume operation on January 27, 2018 The basic requirements for the application materials of PD-1 / PD-L1 monoclonal antibody will be announced on December 12, and the drug Audit Center will hold a special seminar on the requirements for the application materials of PD-1 / PD-L1 monoclonal antibody The meeting discussed the current problems in the research and development of the drug and the preparation of application materials, and formed the basic requirements for application materials, which will be published by the follow-up drug audit center On the 15th of the notice on public solicitation of opinions on "human serum albumin specification (Revised Draft)", the drug Audit Center issued the notice on public solicitation of opinions on "human serum albumin specification (Revised Draft)", stating that human serum albumin has been listed in China for many years, with more than 40 domestic and imported manufacturers, involving nearly 190 approval numbers of products with different specifications In order to standardize the clinical use of the product, the "manual of human serum albumin (Revised Version)" has been formed Now we are seeking opinions from all walks of life The consultation time is one month CDE: the announcement of the Expert Advisory Committee on safety evaluation of traditional Chinese medicine recently, the drug Audit Center established the Expert Advisory Committee on safety evaluation of traditional Chinese medicine, with a total of 40 experts, including 6 academicians and experts According to the center for drug review, the Expert Advisory Committee for safety evaluation of traditional Chinese medicine is under the unified management of other expert advisory committees for drug registration and review Look at the latest hot spots in the market 2017 top ten best-selling anticancer drugs: keytruda growth rate exceeds 170%! According to the sales data of the first three quarters of 2017 disclosed by relevant enterprises, Gen website lists the top 10 best-selling anticancer drugs Among them, Revlimid topped the list with a sales volume of US $5.999 billion Rituxan, Herceptin and Avastin of Roche's McAb "three swordsmen" ranked 2-4 respectively, but the growth was weak Rituxan and Herceptin increased by 2.5% and 2.1% respectively compared with the same period, and Avastin declined even more Among the drugs on the list, neulasta, neupogen and Velcade also showed negative growth Compared with the data of the same period in 2016, keytruda boasts a growth rate of 173.3% In addition, the growth rates of opdivo, imbruvica and ibrance are also very impressive In 2017, the net profit of these enterprises is expected to be more than 1 billion Recently, according to incomplete statistics of network data, in the performance forecast released by the listed pharmaceutical health companies in 2017, there are already 8 companies that are expected to have a net profit of more than 1 billion yuan for the whole year, including Shanghai Laishi, xinlitai, healthyuan, Lizhu group, Bikang, Ruikang pharmaceutical, XinHeCheng and Yifan pharmaceutical On January 16, the first brain tumor registration and research platform in China was officially launched, and the first multi center platform project in the field of nervous system in China, national brain tumor registration and research platform (nbtrc), was officially launched It is reported that the platform will gradually include clinical data of 43 hospitals at different levels from 23 provinces, cities and autonomous regions in China, including Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing University First Hospital, and Capital Medical University sanbo brain hospital In the future, it will be the first public service platform for clinical research of brain tumors in China, and carry out "big data" based on brain tumors The results of large-scale, multi center, high-quality diagnosis and treatment research and clinical diagnosis and treatment standard research Under the pressure of the social strike, Israel has given a lighter punishment to Teva bribery case Recently, according to foreign media, Israel's Ministry of Justice said that the company was fined 22 million US dollars as a settlement plan for Teva to bribe foreign officials to win business in Russia, Ukraine and Mexico In fact, the company's behavior may actually face criminal trial But after Teva was fined $519 million in December 2016 for similar charges in the United States, a month ago, Teva announced plans to cut 14000 jobs globally, including 1750 in Israel, which triggered a general strike in Israeli society For these reasons, Israel decided to abandon the trial and impose a relatively minor fine, and the company expects to save $3 billion by the end of 2019.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.