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FDA approves 50th new drug this year!
Time of Update: 2022-02-23
S. Food and Drug Administration (FDA) has approved the IL-13 inhibitor Adbry (tralokinumab) for the treatment of adult patients 18 years of age or older with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled or treated with topical prescription therapy .
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FDA approves Pfizer's JAK1 inhibitor Cibinqo for atopic dermatitis
Time of Update: 2022-02-23
S. Food and Drug Administration (FDA) has approved its JAK1 inhibitor Cibinqo (abrocitinib) for the treatment of adult patients with relapsing moderate-to-severe atopic dermatitis who should not be treated with existing systemic therapies.
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Centralized procurement of proprietary Chinese medicines: All these large varieties are reduced in price (list attached)
Time of Update: 2022-02-23
Industry insiders believe that the centralized procurement of Chinese patent medicines in 19 provinces in Hubei this time is carried out by pharmaceutical companies that independently fill in information such as enterprise and product information, benchmark prices, and technical evaluation indicators, resulting in the centralized procurement price limit of each variety being "one price for one factory", thus.
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The chairman of Laimei Pharmaceutical has been replaced!
Time of Update: 2022-02-23
On December 30, Lai Mei Pharmaceutical announced that the company's chairman Peng Weimin resigned .
; served as Deputy Manager of Human Resources Department and Deputy Director of the Party Committee Office of Guangxi Longxianggu Investment Co.
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Hengrui Medicine YY-20394 Tablets Obtained Approval Notice for Drug Clinical Trials
Time of Update: 2022-02-23
At the same time, it reached an agreement with Shanghai Yingli, a subsidiary of Yingli Pharmaceutical, and Shanghai Yingli Pharmaceutical granted Hengrui Medicine the joint development rights and exclusive commercialization rights of the PI3kδ inhibitor Linperlisib (R&D code YY-20394) in Greater China ( For details, please refer to the announcement number: Lin 2021-024) .
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How is pharmacovigilance done?
Time of Update: 2022-02-23
The World Health Organization has a specific definition of this term, which is called the discovery, assessment, understanding and prevention of adverse drug reactions or any other drug-related problems, sciences and activities .
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The medical insurance reform goes deeper and the burden on the masses is significantly reduced
Time of Update: 2022-02-23
Continue to reduce the burden of medical expenses for the masses , normalize and institutionalize the centralized procurement of drugs, and strive to achieve a total of more than 350 drugs in the national and provincial centralized procurement within the year.
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First imitation of megastat approved for Niemann-Pick disease type C
Time of Update: 2022-02-23
In January 2009, Zavesca was approved in Europe for the treatment of type C Niemann-Pick disease (NPC), becoming the only drug currently approved for the treatment of NPC in the world .
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Yuekang Pharmaceutical's PED5 Inhibitor Adenafil Citrate Tablets Approved for Marketing
Time of Update: 2022-02-23
05);The safety evaluation results of the two groups of subjects taking oral idenafil citrate or placebo for 4 weeks, 8 weeks and 12 weeks showed that there was a statistically significant difference in the incidence of adverse events between the two groups (P<0.
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Oxycodone Hydrochloride API, a subsidiary of Zhongguancun, passed CDE approval and related injections were approved
Time of Update: 2022-02-23
On January 9, Zhongguancun announced that its subsidiary Beijing Huasu "Oxycodone Hydrochloride API and Injection" recently passed the technical review of the Drug Evaluation Center of the State Drug Administration, "Oxycodone Hydrochloride Injection".
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Leading Biotech Appoints Liu Shusen as Chief Medical Officer
Time of Update: 2022-02-23
Liu Shusen as Chief Medical Officer to lead the company's real-world data strategy and promote the expansion of data commercialization .
He has many years of experience in building and leading real-world evidence teams in multinational pharmaceutical companies.
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Sanhe Pharmaceutical's third-generation EGFR-TKI inhibitor "Oritinib" applied for listing
Time of Update: 2022-02-23
The trial results showed that among the 59 subjects with positive EGFR T790M mutation, the ORR assessed by BICR was 57.
Hansoh Ametinib is the first domestically produced third-generation EGFR-TKI approved for marketing in China, and has been approved by the NMPA for first-line and second-line treatment of NSCLC .
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Ascletis Pharma Submits U.S. Clinical Trial Application for Oral PD-L1 Small Molecule Inhibitor
Time of Update: 2022-02-23
On January 10, Ascletis announced that the company has submitted a US clinical trial application (IND) for ASC61, an oral PD-L1 small molecule inhibitor developed by itself, for the treatment of advanced solid tumors .
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A large number of drug and medical insurance payment restrictions have been lifted (with list attached)
Time of Update: 2022-02-23
Inner Mongolia (30 )Inner Mongolia (30On December 31, 2021, the Inner Mongolia Medical Insurance Bureau issued a notice to carry out the pilot work of medical insurance drug payment standards, stipulating that insured patients use drugs with a price not higher than the payment standard, and patients and medical insurance funds are based on the actual sales price and share according to policy regulations.
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Chinese PD-(L)1 "roll" to the United States?
Time of Update: 2022-02-23
2022 FDA Approval Plan for PD-(L)1 Monoclonal AntibodySource: evaluatePD-(L)1 is "rolling" all over the worldPD-(L)1 is "rolling" all over the worldAccording to Yaozhi data, as of January 6, 2022, the total number of global clinical trials of PD-1 target drugs has reached 3471, of which China (CDE registration) is 675, accounting for about 19.
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Betta Pharmaceuticals submits a marketing application for a new generation of multi-targeted kinase inhibitors
Time of Update: 2022-02-23
The Phase 2/3 CONCEPT clinical study of voronib combined with everolimus in the treatment of patients with advanced renal cancer is currently progressing smoothly and shows good efficacy and safety .
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Investigational Alzheimer's disease drug lecanemab receives US FDA Fast Track designation
Time of Update: 2022-02-23
A Phase 3 clinical study of lecanemab Clarity AD in early AD is ongoing and completed enrollment in March 2021 with a total of 1,795 patients .
The FDA has agreed that the Clarity AD results, when completed, could serve as a validation study to validate the clinical benefit of lecanemab .
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The first in the country!
Time of Update: 2022-02-23
Article source: Medical Cube InfoOn January 10, the official website of CDE showed that the clinical application of Sunshine Guojian's monoclonal antibody SSGJ-617 targeting PSGL-1, a subsidiary of 3SBio, was accepted by the State Food and Drug Administration .
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CDK4/6 inhibitors are the key to accurate diagnosis, classification and treatment of early breast cancer
Time of Update: 2022-02-23
That is, abeccil tablets combined with endocrine therapy (tamoxifen or aromatase inhibitor) as adjuvant therapy are suitable for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, lymph node positive, high Adult patients with early-stage breast cancer at risk of recurrence and Ki-67 ≥20% .
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Coba Bio's original monoclonal antibody SPX-101 starts phase I clinical trial in the United States
Time of Update: 2022-02-23
According to Professor Spira's previous enrollment records, the clinical trial is expected to be completed by the end of 2022 .
