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To Biao Hengrui and Sanofi!
Time of Update: 2021-05-22
Medical Network News, May 8 Recently, the official website of the State Food and Drug Administration showed that the docetaxel injection of Sichuan Meida Kangjiale Pharmaceutical was approved as a supplementary application.
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Chia Tai Tianqing approved the third high-end generic drug this year, pointing to Merck's heavy variety
Time of Update: 2021-05-21
Pharmanet News, May 14 Recently, Chia Tai Tianqing Pharmaceutical Group's application for the imitation of Aprepitant Capsule 4 was approved, becoming the second domestic pharmaceutical company to be approved for the product and deemed to have been reviewed.
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Roche's innovative anti-influenza drug Sufuda® was officially approved in China
Time of Update: 2021-05-10
On April 29, Roche China announced that its innovative flu drug Sufuda® (English trade name: Xofluza®, Chinese generic name: Mabaloxavir) has been formally approved by the China National Medical Products Administration for the treatment of 12 years of age and The above acute uncomplicated influenza patients include those who are at high risk of influenza complications.
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The reasons for the suspension of Roche's tominersen phase III trial were repeated, and analysts put forward four hypotheses
Time of Update: 2021-05-10
Roche said that after the independent data committee "has questioned the benefits and safety risks of subjects receiving tominersen therapy," Roche decided to stop late-stage clinical trials of the antisense drug tominersen for huntingtin and mutants.
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Roche's flu drug "Mabaloxavir" approved for listing in China
Time of Update: 2021-05-10
The results of the study showed that the median flu symptom improvement time (TTIIS) of patients in the mabaloxavir group was shorter than that of the oseltamivir group and placebo group, which were 73.
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Johnson & Johnson CD38 monoclonal antibody new indication approved in China, sales of 4.19 billion U.S. dollars in 2020
Time of Update: 2021-05-10
Although many progresses have been made in the treatment of multiple myeloma in recent years, most patients still face the problem of relapse or drug resistance.
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GSK's first-quarter results failed to meet expectations and will reduce more anti-cancer drug inputs
Time of Update: 2021-05-10
GSK revealed in the first quarter report that due to the priority of its product portfolio, the company will abandon the phase I development plan of DMD's hematopoietic prostaglandin D2 synthase inhibitor GSK3439171 and the oncology drug candidate GSK3537142 in cooperation with Immunocore.
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Hengrui PD-1 nasopharyngeal carcinoma indication approved
Time of Update: 2021-05-10
The approved indication is: for the treatment of advanced nasopharyngeal carcinoma patients who have previously received second-line or above chemotherapy and have advanced or intolerable disease.
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Novo Nordisk's "once a week" new diabetes drug is officially approved in China
Time of Update: 2021-05-10
On April 29, Novo Nordisk issued a press release stating that the National Medical Products Administration (NMPA) has approved Novo Nordisk's research and development and production of Novotel® (Smeglutide Injection) in China for the listing application.
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Cinda ophthalmic drug IBI302 Phase II clinical completed the first patient administration
Time of Update: 2021-05-10
In the ongoing phase II clinical study, in addition to evaluating the efficacy of IBI302 in improving vision and retinal thickness, it will also focus on its potential improvement effect on macular atrophy and fibrosis.
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Chengdu Xiandao HG146 Capsule New Indication Clinical Trial Application Approved
Time of Update: 2021-05-10
HG146 (HDAC I / IIb subtype selective small molecule inhibitors) is a pilot structure developed Chengdu Ying, proprietary, selective class I and class IIb histone deacetylase (HDAC) inhibitor , On April 12, 2018, obtained the original clinical approval of the National Food and Drug Administration (approval number: 2018L02338, 2018L02339), and is currently conducting clinical research on multiple myeloma.
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Osaicam posaconazole injection is about to pass the consistency evaluation
Time of Update: 2021-05-10
Recently, NMPA official website data shows that Osaikon’s posaconazole injection 3 types of imitation listing applications have entered the "under review" status, and it is expected to win the first domestic imitation + first review.
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Improved new drug "Budesonide Sustained Release Capsules" receives FDA priority review for the treatment of IgA nephropathy
Time of Update: 2021-05-10
On April 28, Calliditas announced that its new drug application (NDA) for Nefecon (Budesonide Sustained Release Capsules) has been accepted by the FDA for the treatment of IgA nephropathy.
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Pfizer acquires Amplyx to expand anti-infective drug R&D pipeline
Time of Update: 2021-05-10
Amplyx's lead compound fosmanogepix (APX001) is a drug candidate under development for the treatment of invasive fungal infections.
In addition to fosmanogepix, through this acquisition, Pfizer also acquired the ownership of Amplyx's early-stage pipeline, which includes potential antiviral (MAU868) and antifungal (APX2039) therapies.
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6 best-selling anti-tumor varieties can be used by children in Hengrui, Hausen, and Yangtze River...the product has exploded
Time of Update: 2021-05-10
According to data from Meinenet, the above-mentioned 6 anti-tumor drugs are all varieties of the 2020 National Medical Insurance Catalogue, and domestic giants such as Hengrui, Qilu, Shuanglu Pharmaceutical, Baiyunshan, and Yangzijiang have layouts.
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A well-known pharmaceutical company of RMB 487.5 million was acquired to deploy innovative drug research and development
Time of Update: 2021-05-08
5 million yuan, a well-known pharmaceutical company was acquired Well-known pharmaceutical company was acquired Huadong Medicine announced the acquisition of a 75% stake in Zhejiang Daoer Biotechnology Co.
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CStone's KIT/PDGFRA mutant kinase inhibitor avatinib was approved in China
Time of Update: 2021-05-03
Today, China’s National Food and Drug Administration (NMPA) drug approval certificate pending information shows that the KIT and PDGFRA mutant kinase inhibitor avapritinib (previously used Chinese name: apotinib) declared by CStone Pharmaceuticals is already available China was approved.
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200 million dollars!
Time of Update: 2021-05-03
. Tarsus has completed four phase II clinical trials of TP-03 for the treatment of Demodex blepharitis.
Currently, TP-03 is being studied as a potential treatment method to alleviate some key elements of meibomian gland dysfunction by eliminating demodex sebaceous mites.
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ATG-019 clinical trial application for the treatment of advanced solid tumors and non-Hodgkin's lymphoma was approved in China
Time of Update: 2021-05-03
Deck Pharmaceuticals announced today that the State Food and Drug Administration has approved the application of ATG-019 to start a phase I clinical trial, which aims to evaluate ATG-019 (single agent or combined with niacinER) in advanced solid tumors or non-Hodgkin’s lymphoma in China Safety and tolerability in patients.
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Janssen/Legendary Bio-CAR-T Therapy Completes Rolling Submission of FDA Biological Products License Application
Time of Update: 2021-05-03
A few days ago, Legendary Biotech stated in the regulatory documents submitted to the US SEC that the company’s partner Janssen has completed the rolling submission to the US FDA for the B-cell maturation antigen (BCMA) CAR-T therapy ciltacabtagene autoleucel ( cilta-cel) Biologics License Application (BLA) for the treatment of adult patients with relapsed/refractory multiple myeloma.
