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Notice of the State Food and Drug Administration on Issuing the Catalogue of Generic Drug Reference Preparations (The 52nd Batch) (No. 16 of 2022)
Time of Update: 2022-04-16
After being reviewed and confirmed by the Expert Committee on the Consistency Evaluation of Generic Drug Quality and Efficacy of the State Drug Administration, the catalogue of generic drug reference preparations (the fifty-second batch) is hereby released .
hereby notified .
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The shortage of raw materials in China has made it worse, this time is related to the conflict between Russia and Ukraine!
Time of Update: 2022-04-16
Statistics from China COFCO show that in the past 6 years, China's corn starch production has been increasing year by year .
In the past 10 years, Ukraine, known as the "granary of Europe", has gradually become a new source of imported corn for China .
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Guangdong Provincial Drug Trading Center issued a notice: 87 major varieties began to be purchased in volume
Time of Update: 2022-04-16
(3) The content of the objection feedback materials submitted by the enterprise should be true, valid, clear and complete, targeted and unambiguous, and legal and valid evidence materials (including but not limited to certification documents stamped with the official seal of the provincial drug procurement department, winning bids) should be provided in accordance with laws and regulations.
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The National Health and Medical Commission publicly solicits opinions on the "Working Plan for the Temporary Import of Drugs Urgently Needed in Clinical Practice"
Time of Update: 2022-04-16
Department of Pharmaceutical Affairs, National Health Commission March 29, 2022 attachment1 Work Plan for Temporary Import of Drugs Urgently Needed in Clinics (Draft for comments) In order to further improve the drug supply guarantee policy and meet the people's specific clinical urgent needs for drug use, this plan is hereby formulated in accordance with the relevant provisions of the "Pharmaceutical Administration Law of the People's Republic of China" .
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In the post-"National Talk" era, we have passed the original research instead of the countercurrent
Time of Update: 2022-04-16
Medical insurance negotiation comprehensively uses decision-making tools such as pharmacoepidemiology, pharmacoeconomics, and health technology evaluation, starting from the clinical value of drugs and the unmet needs of patient groups, and taking the affordability of medical insurance funds and drug cost-effectiveness ratio as external and internal price constraints respectively .
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CDE Releases the 56th Batch of Chemical Generic Drug Reference Preparations Solicitation Notice
Time of Update: 2022-04-16
Center for Drug Evaluation, State Drug Administration March 1, 2022 Original attachment: [1] "Catalogue of Reference Preparations of Chemical Generic Drugs (The Fifty-sixth Batch)" (Draft for Comment) (1) [2] Application form for objection to chemical generic drug reference preparations If this article violates your rights, please contact us .
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Jimin Trusted lgE antibody drug IND approved by CDE
Time of Update: 2022-04-16
Its research and development pipeline covers biological macromolecular innovative drugs, chemical small molecule innovative drugs, innovative traditional Chinese medicine, complex Generic and high-end preparations are committed to making breakthroughs in the therapeutic fields of kidney disease, tumor, cardiovascular and cerebrovascular, respiratory system, anti-infection, pediatrics, pain, etc.
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80% of the bids were renewed, with ups and downs. The prices of pemetrexed and dexmedetomide dropped sharply, and the results of the centralized procurement in the Yangtze River Delta were released.
Time of Update: 2022-04-16
2. The price has gone up and down On the basis of the national procurement price, the price of the selected enterprises for the renewal of the bid has dropped significantly .
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NMPA newly revised the "Quality Management Practice for Clinical Trials of Medical Devices", which will be implemented from "May 1st"
Time of Update: 2022-04-16
It is reported that in 2016, the former State Food and Drug Administration, together with the former National Health and Family Planning Commission, issued the "Quality Management Practice for Clinical Trials of Medical Devices" (CFDA Order No.
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A large number of pharmaceutical companies in Shanghai press the pause button
Time of Update: 2022-04-16
01 A large number of pharmaceutical companies in Shanghai were closed and managed From 5:00 on March 28th, Shanghai Pudong New Area will implement closure and control management .
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Whoever wins the new crown wins the world!
Time of Update: 2022-04-16
With the great success of the new crown vaccine product Spikevax, Moderna’s market value was close to $200 billion in August 2021, and it has more than 20 times in one year .
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Huadong Medicine 2 major BD deals in 7 days!
Time of Update: 2022-04-16
Based on a number of BD transactions, Huadong Medicine has gradually formed a global ADC R&D ecosystem, and built a world-class independent R&D industry platform in the ADC field to continuously develop differentiated ADC innovative drugs .
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210 million yuan to introduce!
Time of Update: 2022-04-16
In China, a total of 4 long-acting Baiyao products have been approved for marketing, including Jinyouli from CSPC , Xinruibai from Qilu Pharmaceutical, Aido (19K for short) from Hengrui Medicine, and recombinant human granulocytes from Shandong New Era.
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Roche launched a HER2-ADC price war, which domestic companies may stand out
Time of Update: 2022-04-16
On January 21, 2020, T-DM1 was launched in China for the adjuvant treatment of patients with HER2-positive early breast cancer with residual invasive disease after receiving taxanes combined with trastuzumab-based neoadjuvant therapy It has become the first approved HER2-ADC drug in China, opening a new era of antibody-drug conjugate (ADC) therapy in China .
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The State Food and Drug Administration has approved 12 new coronavirus antigen detection reagents
Time of Update: 2022-04-16
On March 15, after review by the State Food and Drug Administration, two new coronavirus antigen detection reagent products were approved .
As of March 16, the State Food and Drug Administration has approved 12 new coronavirus antigen detection reagent products .
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PHEXCOM VIP member unit IMCD is looking for sales managers!
Time of Update: 2022-04-16
Job Title: Sales ManagerSales Manager Responsibilities: 1.
Responsible for the promotion of pharmaceutical excipient products and create more business opportunities 2.
Develop and update sales forecasts in a timely manner, as well as the collection of accounts receivable 5.
Strong communication skills and business development skills 4.
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The CDE article is a small auxiliary material, and the wrong use can also lead to life!
Time of Update: 2022-04-16
At present, China only proposes specific GMP requirements for excipient manufacturers to ensure the quality of excipients, but has not yet established a complete risk assessment system and guidelines for excipients, especially for MAH .
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Hu Shanlian: Frontier Tracking of the Cost-effectiveness of New Crown Oral Drugs
Time of Update: 2022-04-16
The results of the phase III clinical trial were: the hospitalization and mortality rate of the treatment group was 7.
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Heavy!
Time of Update: 2022-04-16
[2] "Chronic kidney disease kills 5 to 10 million people worldwide each year, and the lives of many patients are severely impacted by frequent dialysis treatments," said Associate Professor William Herrington, University of Oxford Population Health Clinical Scientist, Honorary Consultant in Nephrology, and EMPA-KIDNEY Co-Principal Investigator .
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Eli Lilly, BMS, Roche, AstraZeneca lead the most anticipated new drug launch in 2022
Time of Update: 2022-04-16
donanemab [company] Eli Lilly [indication] Alzheimer's disease [2026 sales forecast] $6 billion In June last year, Biogen’s Aduhelm (aducanumab) targeting beta amyloid received accelerated approval from the FDA, and Evaluate had predicted that the drug’s peak sales in 2026 would be about $4.
