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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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[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.
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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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Aide Biotech and Haihe Pharmaceutical reached a targeted drug clinical research cooperation
Time of Update: 2021-04-28
On March 12, 2021, Aide Bio announced that it has reached a targeted drug clinical research cooperation with Haihe Pharmaceuticals, and the company’s self-developed "MET detection kit" will serve as a
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Vertex begins Phase 1/2 clinical trial of VX-880 experimental treatment
Time of Update: 2021-04-28
Vertex Announces FDA Fast Track Designation and Initiation of a Phase 1/2 Clinical Trial for VX-880, a Novel Investigational Cell Therapy for the Treatment of Type 1 Diabetes
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ADC research and development is normalizing Pfizer but "quietly" changed hands to others!
Time of Update: 2021-04-28
Pfizer began to "retreat" from the ADC field?On March 18, Pfizer and American biotechnology company Pyxis Oncology (hereinafter referred to as "Pyxis") jointly announced that the two parties have reached a global licensing agreement for two ADC (antibody-drug conjugate) candidate products, but specific transactions The amount was not disclosed.
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A batch of large varieties meets the conditions of the fifth batch of centralized procurement
Time of Update: 2021-04-28
With the gradual acceleration of the consistency evaluation of injections, more and more varieties will meet the requirements for centralized procurement, or may be included in the upcoming fifth batch of national centralized procurement.
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Another multinational pharmaceutical company splits up mature products
Time of Update: 2021-04-28
Recently, Daiichi Sankyo announced at a board meeting that it had passed a resolution to transfer the production and sales rights of the company’s 11 mature drugs in Japan to Alfresa’s subsidiary, Alfresa Pharmaceuticals.
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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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CCTV Exposure: The price of Chinese medicine has risen again
Time of Update: 2021-04-28
The new version of the Pharmacopoeia has raised the quality requirements for many varieties, especially the heavy metal content and pesticide residues of drugs, which directly led to the increase in the price of medicinal materials that meet the standards.
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The first FDA approved pericarditis therapy! IL-1 inhibitors are expected to change the treatment paradigm
Time of Update: 2021-04-28
S. FDA has approved the company’s IL-1 inhibitor Arcalyst (rilonacept) to be marketed for the treatment of patients over 12 years of age with recurrent pericarditis and to reduce the risk of recurrence of pericarditis.
"Reference materials:[1] Kiniksa Announces FDA Approval of ARCALYST ® (rilonacept) for Recurrent Pericarditis.
Retrieved March 18, 2021, from Kiniksa-Announces-FDA-Approval-of-ARCALYST-rilonacept-for-Recurrent-Pericarditis.
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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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The 20 best-performing new drugs in the market in 2020
Time of Update: 2021-04-28
It was first approved for marketing in the United States in December 2019, with sales revenue of US$200 million in the first year.
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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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The new version of the medical insurance catalog implements three PD-1 prices, and the annual fee of Hengrui Erica is less than 10,000
Time of Update: 2021-04-28
It is also understood that the new price of BeiGene’s PD-1 tislelizumab (trade name: Beizian) before medical insurance reimbursement has dropped to 2180 yuan per tube, a drop of up to 80%, and the annual treatment cost is only less than 7.
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Unlicensed pharmacist pharmacy fined 50,000
Time of Update: 2021-04-28
. On March 2, the inspection focus of Shanxi Province's "Notice on Printing and Distributing the Provincial Drug Circulation Supervision and Inspection Work Plan in 2021" also talked about the investigation of illegal behaviors such as non-compliance in the sales of prescription drugs and "certification" of licensed pharmacists.
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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.
