-
What should a Chinese pharmaceutical company License in do?
Time of Update: 2022-02-24
However, returning to the product development path, the vast majority of domestic companies have almost become "we do not produce innovation, but only be innovative porters": they have won foreign clinical stage projects, and then prepared to copy the indications under research in Europe and the United States basically as they are in China.
-
Qilu broke out!
Time of Update: 2022-02-24
At the stage of clinical application and above, 17 innovative macromolecular drugs, ALK/ROS1 inhibitor Yiluoke tablets have been submitted for NDA; generic drugs have entered the intensive harvest period, 21 new products have been won this year, and a total of 93 varieties have been reviewed (40 are the first ones), 11 new categories of reported product varieties are sprinting for the first imitation, and 25 over-evaluated varieties meet the conditions for national procurement .
-
Tengsheng Biopharma's Phase I clinical trial of HIV drug BRII-732 suspended by FDA
Time of Update: 2022-02-24
Article source: Medical Cube InfoAuthor: infoOn December 12, Tengsheng Biopharmaceutical announced that it had received a notice from the US FDA to suspend the Phase I clinical study evaluating the safety of BRII-732 in healthy subjects .
-
Telmisartan Tablets, a Subsidiary of Shanghai Pharmaceuticals, Passed the Consistency Evaluation of Generic Drugs
Time of Update: 2022-02-24
On December 23, Shanghai Pharmaceuticals announced that its holding subsidiary Shandong Xinyi received the “Approval Notice for Supplementary Drug Application” (Notice No. : 2021B04537) issued by the
-
Pfizer's antifungal drug "isavuconazole" approved in China
Time of Update: 2022-02-24
Article source: Pharmaceutical GuanlanOn December 16, China's National Medical Products Administration (NMPA) announced the latest announcement that the marketing application for isavuconazole sulfate capsules, a new anti-infective drug introduced by Pfizer, has been approved .
-
In November, Hengrui Medicine, Zai Lab, Livzon Group, etc. reached new drug authorization cooperation
Time of Update: 2022-02-24
1. Introducing party: SongliLicensee: Suzhou Corning JerehDrug mechanism of action: anti-PD-L monoclonal antibodyOn November 8, Ascletis and Suzhou Corning Jerry announced that they have reached an exclusive global development agreement for ASC22 (envolimab, also known as KN035) to treat all viral diseases including hepatitis B outside of Greater China .
-
Major revision!
Time of Update: 2022-02-24
On the basis of formulating the "Medical Waste Classification Catalog", the National Health Commission also formulated the "Medical Waste Exemption Management List" (hereinafter referred to as the "List") .
-
Continuous Photochemical Technology Successfully Applied in Commercial Production of HIF-2α Inhibitors
Time of Update: 2022-02-24
TextPharmaceutical GuanlanRecently, Merck & Co (MSD) and the flow chemistry team of Hequan Pharmaceutical published a paper entitled "Manufacturing Process Development for Belzutifan, Part 2: A Continuous Flow Visible-Light-Light- Induced Benzylic Bromination" paper .
-
The application for registration of new anticancer drug of Haite Biotech has been accepted
Time of Update: 2022-02-24
CPT is a new recombinant protein targeting anti-tumor drug developed by its joint-stock subsidiary Beijing Shadong Biotechnology Co.
Phase III clinical trials have shown that CPT combined with TD regimen in the treatment of relapsed and refractory multiple myeloma can significantly improve the progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) of patients.
-
Emmy and Weixin's 13-valent pneumococcal vaccine enters Phase 3 clinical trials
Time of Update: 2022-02-24
According to the drug clinical trial registration and information publicity platform, the vaccine developed by Emmy Weixin includes 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) ) pneumococcus .
-
AHA's 2021 Cardiovascular Medicine Progress "All-in-One" Drug Re-recommended
Time of Update: 2022-02-24
FIGARO-DKD Trial: In patients with type 2 diabetes and chronic kidney disease, finerenone reduced the risk of the composite endpoint of cardiovascular events by 13% compared with placebo, with the main improvement being a reduction in hospitalizations for heart failure .
-
Why is it so difficult to develop anticancer drugs?
Time of Update: 2022-02-24
Translated into tumor drug research and development, what is the real hallmark of tumors is the primary issue, which will profoundly affect the selection of targets, treatment strategies, and evaluation systems .
-
Pfizer's JAK inhibitor secures fifth indication for active ankylosing spondylitis
Time of Update: 2022-02-24
S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for tofacitinib (Xeljanz), an oral small molecule JAK inhibitor, for the treatment of a Adult patients with active ankylosing spondylitis (AS) who have inadequate response to, or intolerance to, multiple tumor necrosis factor (TNF) blockers .
-
GlaxoSmithKline poachs Pfizer's vaccine R&D chief
Time of Update: 2022-02-24
Phil Dormitzer, who previously served as vice president and chief scientific officer for RNA and viral vaccines at rival Pfizer, will join the British company as its new global head of vaccine development, according to the latest news .
-
FDA approves emergency use of second oral drug to treat COVID-19
Time of Update: 2022-02-24
S. Food and Drug Administration approved the first oral drug for emergency use in the treatment of new coronavirus infections on the 22nd .
-
The Phase III pivotal clinical IND of IMG-020 was accepted by CDE
Time of Update: 2022-02-24
On December 23, Chuangxiang Bio announced that the Center for Drug Evaluation (CDE) of the State Drug Administration has officially accepted the IND application of its candidate drug izokibep (IMG-020) for the treatment of plaque psoriasis.
. Previously, Izokibep has successfully completed a phase II clinical study for psoriasis in Germany .
-
Pfizer's Oral Covid-19 Drug Paxlovid Receives FDA Emergency Use Authorization
Time of Update: 2022-02-24
S. Food and Drug Administration (FDA) has approved an Emergency Authorization Application (EUA) for its novel COVID-19 oral antiviral drug candidate Paxlovid for the treatment of non-hospitalized adults with COVID-19 infection at high risk of developing severe disease .
-
Dyne Pharmaceutical's Lycorine Hydrochloride Thioester for Injection Obtained Approval for Drug Clinical Trials
Time of Update: 2022-02-23
At present, the drugs for the treatment of hand, foot and mouth disease that other companies have declared in China and intend to continue to develop are mainly oral dosage forms .
-
CSPC Lenvatinib Mesylate Capsules Approved for Marketing
Time of Update: 2022-02-23
On January 11, the official website of NMPA showed that CSPC's mitoxantrone hydrochloride liposome injection and lenvatinib mesylate capsules were approved for marketing .
Sales of Eisai Lenvatinib in China (unit: RMB million)Source: Sales Database of Multinational Listed Companies on Minet.
-
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 .
