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Talking about: Understanding the gene toxicity of drugs from the pharmacology & toxicology & warning structure
Time of Update: 2021-04-29
Table 2: ICH S2 (R1) Guiding Principles Standard Test Combination05Representative events of drug genotoxicity in historyIn June 2007, Roche Pharmaceuticals launched the HIV protease inhibitor nelfinavir mesylate in the European market.
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Overview of the top ten blockbuster drugs in 2021
Time of Update: 2021-04-29
Just one month later, one year after entering the Alport Cardinal study, Reata provided positive Phase III data at the end of 2019, showing that patients receiving the drug had better renal function after 48 weeks of treatment, and continued improvement after 4 weeks of stopping the drug.
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Sanofi/Dupixent, a new pediatric asthma drug, enters review in the U.S.
Time of Update: 2021-04-28
S. Food and Drug Administration (FDA) has accepted the anti-inflammatory drug Dupixent (Chinese trade name: Dabituo, generic name: dupilumab, dupilumab) ) A supplementary biological product license (sBLA), as an add-on therapy for the treatment of children with moderate to severe asthma who are 6-11 years old and whose condition is uncontrolled.
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YP01001 Capsule, a subsidiary of Fosun Pharma, was approved to carry out clinical trials for advanced solid tumors
Time of Update: 2021-04-28
(hereinafter referred to as "Chongqing Yaoyou") received the State Food and Drug Administration's approval for the use of YP01001 capsules for the treatment of advanced solid tumors Approval to carry out clinical trials.
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Anhui initiates emergency procurement negotiations on Zhifei Biotech's new crown vaccine
Time of Update: 2021-04-28
On March 22, the Anhui Provincial Center for Disease Control and Prevention issued the "Announcement on Emergency Procurement Negotiations for Emergency Use of Recombinant Novel Coronavirus Vaccines (CHO Cells) in Anhui Province".
Vaccine (CHO cell), the relevant manufacturer is Anhui Zhifeilongkoma Biopharmaceutical Co.
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The best pharmaceutical companies in the hearts of American employees: Horizon, Genentech, and AbbVie are among the top three
Time of Update: 2021-04-28
In this year's industry survey, GreatPlacetoWork compiled the annual ranking of Fortune by using an anonymous survey of more than 825,000 employees from the US medical and pharmaceutical industries.
"Reference source: Horizon, Roche's Genentech, AbbVie and Neurocrine rank as top pharma places to work in annual poll
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The first domestic epothilone class 1 new drug Utidelon injection is about to be approved
Time of Update: 2021-04-28
Among them, CTR20150579 is a phase III clinical study aimed at evaluating UTD1 injection combined with capecitabine in the treatment of patients with advanced metastatic breast cancer.
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An Ping joins Organon as the head of cardiovascular sales
Time of Update: 2021-04-28
On March 15th, Shi Wang, the head of Organon China, announced that An Ping would join the company from now on, serving as the National Senior Sales Director of Cardiovascular Product Line of the Classic Brand Hospital Division.
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CSPC obtained the exclusive domestic authorization of the third-generation EGFR-TKI of Beierda Pharmaceutical
Time of Update: 2021-04-28
has entered into a product licensing and commercialization agreement with Shanghai Beierda Pharmaceutical to obtain the third-generation EGFR-TKI (BPI) through equity subscription.
-7711 capsules) exclusive product authorization and commercialization rights.
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A commonly used OTC nationwide recalled pharmacy is suspended from sale
Time of Update: 2021-04-28
The Sichuan Provincial Food and Drug Administration requires that all municipal (prefecture) market bureaus and inspection branches of the Provincial Food and Drug Administration immediately supervise and urge drug dealers and users within their jurisdictions to take risk control measures such as suspension of sales and use and removal of the above-mentioned products, and assist in doing a good job Relevant work on drug recalls and strengthen risk monitoring of the product.
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China's new coronavirus therapeutic antibody drug is approved for emergency use in Europe and the United States
Time of Update: 2021-04-28
The institute stated that this indicates that the safety and effectiveness of new coronavirus-specific antibody drugs with China's independent intellectual property rights have been recognized by the world.
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Qiyu Biological Bispecific Antibody Q-1802 Obtained IND Approval in the U.S.
Time of Update: 2021-04-28
Q-1802 is the first clinical application project of Qiyu Biologics, which was independently developed by Qiyu Biologics using its antibody engineering technology platform.
It has independent intellectual property rights and can simultaneously target PD-L1 and Claudin 18.
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Newest | These 20 best selling drugs
Time of Update: 2021-04-28
11Hospital market, Top 20 drugsHospital market, Top 20 drugsAccording to the full-year data information of the PDB (PDB) in 2020, affected by the new crown epidemic, the market sales of sample hospita
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Pfizer's lorlatinib receives FDA approval for first-line treatment of ALK-positive metastatic lung cancer
Time of Update: 2021-04-28
S. FDA has approved the Supplemental New Drug Application (sNDA) for Lorbrena (lorlatinib), expanding the indications to include anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) patients First-line treatment.
Reference materials:[1] US FDA EXPANDS APPROVAL OF PFIZER'S LORBRENA® AS FIRST-LINE TREATMENT FOR ALK-POSITIVE METASTATIC LUNG CANCER.
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What is the production capacity of China's antibody drugs? Can the situation of key equipment and materials be broken by import?
Time of Update: 2021-04-28
In recent years, China's antibody drug commercialization production capacity has made considerable progress, but the overall production capacity is insufficient, the production capacity is scattered, the process experience is lacking, the core equipment and materials have not been localized, and the production talent echelon has not yet formed.
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Process|Asymmetric synthesis solution of alogliptin preparation process
Time of Update: 2021-04-28
The process uses compound 2 as a raw material, and firstly undergoes a substitution reaction with intermediate 3 under alkaline conditions to obtain intermediate 4; intermediate 4 is condensed with chiral raw material 5 to obtain Alogliptin (1 ) And then benzoic acid to form the target product Alogliptin (1) benzoate.
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Sihuan Biotechnology received a civil complaint involving three securities misrepresentation liability disputes
Time of Update: 2021-04-28
On March 20, Sihuan Biological issued an announcement stating that the company received a civil complaint and response from the Nanjing Intermediate People’s Court (2021) Su01 Minchu No.
, Kunshan Venture Holding Group Co.
, and Kunshan Venture Capital Co.
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O, K, I, T drug indications have been withdrawn one after another, or there will be more withdrawals...
Time of Update: 2021-04-28
9 months) of the Phase I/II CheckMate-032 trial results for SCLC, the FDA approved Opdivo for the treatment of platinum Patients with small cell lung cancer whose disease has progressed after drug-like chemotherapy and at least one other treatment.
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New ADC drug Padcev applies for marketing in Japan: treats patients refractory to PD-(L)1 inhibitors
Time of Update: 2021-04-28
The Phase 3 EV-301 confirmatory trial was conducted in adult patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-based chemotherapy and a PD-1/L1 inhibitor, comparing Padcev with chemotherapy.
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[Approved] Qilu won 500 million oral hypoglycemic drugs!
Time of Update: 2021-04-28
com, the sales of saxagliptin tablets at the terminal of Chinese public medical institutions have grown rapidly in recent years, breaking the 500 million mark in 2019, and a year-on-year increase of more than 30% in the first half of 2020.
