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With the power of innovation, domestic pharmaceutical companies will bring new treatment options for more HIV-infected patients
Time of Update: 2022-12-30
On October 29, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration showed that GSK/ViiV Healthcare's HIV (HIV) drug Cabotegravir injection and cattegravir sodium tablets were declared for marketing for new indications, which is expected to become the first complete long-acting HIV therapy on the domestic market, which will shorten the number of days for infected patients from 365 days to 6 or 12 days.
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Oncocross Announces Initiation of Global Phase 1 Clinical Trial of Investigational Therapy OC514
Time of Update: 2022-04-30
A few days ago, Oncocross, an artificial intelligence-based drug development company, announced the initiation of a global Phase 1 clinical trial of its investigational therapy OC514 for the treatment of muscle diseases including sarcopenia .
References:[1] Oncocross Begins Clinical Trial for AI-Developed Drug for Sarcopenia.
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Pfizer's RSV vaccine receives FDA breakthrough therapy designation for "medical masks" to prevent lower respiratory tract diseases in the elderly
Time of Update: 2022-04-28
S. Food and Drug Administration (FDA) breakthrough Sexual therapy designation for the prevention of lower respiratory tract disease caused by RSV in people 60 years of age or older .
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Available soon
Time of Update: 2022-02-20
January 25, 2022 / eMedClub PR News / -- Alnylam recently announced that a Phase 3 trial, HELIOS-A, of its RNAi therapy vutrisiran for the treatment of transthyretin-mediated (ATTR) amyloidosis, in All of its secondary endpoints were met at 18 months in adult patients with hereditary transthyretin amyloidosis polyneuropathy (hATTR-PN) compared with placebo in neuropathy impairment, quality of life (QoL), gait There were statistically significant improvements in speed, nutritional status and overall disability .
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The State Food and Drug Administration cancelled the drug registration certificate of Lianbizhi injection
Time of Update: 2022-01-23
After evaluation, the State Drug Administration decided to stop the production, sales and use of Lianbizhi injection in China from now on, and cancel the drug registration certificate .
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Targeting CLDN 18.2
Time of Update: 2022-01-15
According to the press release of Keji Pharmaceuticals, CT041 has been approved by the US FDA, China National Medical Products Administration (NMPA) and Health Canada to conduct clinical trials .
Reference materials:[1] The Canadian clinical trial of CT041, a CAR-T product independently developed by Keji Pharmaceuticals, was approved.
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The State Food and Drug Administration issued a notice that 2 batches of Quantai Pharmaceuticals did not meet the requirements
Time of Update: 2022-01-12
1. According to the inspection of Hubei Provincial Institute of Drug Supervision and Inspection, a batch of Atractylodes japonicus produced by Hebei Quantai Pharmaceutical Co.
According to the inspection by Qinghai Provincial Drug Inspection and Testing Institute, a batch of wood incense produced by Hebei Quantai Pharmaceutical Co.
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The first domestic hormone replacement therapy for the treatment of hypoparathyroidism was approved for Phase III clinical press release
Time of Update: 2021-06-18
—VISEN Pharmaceuticals obtained the China Phase III clinical trial (PaTHway China trial) for TransCon PTH injection (ie TransCon™ parathyroid hormone) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) Approval .
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FDA extends the review period for supplementary new drug applications for AbbVie RINVOQ due to safety considerations
Time of Update: 2021-04-28
CompileLiLiOn March 17, according to foreign media reports, AbbVie announced that the US FDA has extended the review period for the anti-inflammatory drug RINVOQ Supplemental New Drug Application (sNDA) for the treatment of active psoriatic arthritis (PsA) in adults.
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Siddi Medicine obtains the exclusive authorization of the new generation of CD47 antibody drug in Greater China
Time of Update: 2021-04-14
On March 31, 2021, Sidi Medicine, located in the Shanghai International Medical Park of Zhangjiang Science City, announced that it has obtained ImmuneOncia Therapeutics' new generation anti-CD47 monoclonal antibody IMC-002 tumor indication in Greater China (Mainland China, Hong Kong, Macau and Taiwan) The exclusive authorization for the development, production and commercialization of The company plans this year to the State Drug Administration submitted a clinical trial application (IND) Bureau (NMPA).
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Shanghai pharmaceutical cephalosporading capsules are evaluated by generic consistency
Time of Update: 2021-01-19
On January 7, Shanghai Pharmaceutical Holding Subsidiary, XinAIA Bank, received the "Notice of Approval of Drug Supplemental Application" (Notice No. 2020B05358) issued by the State Drug Administration on cephalosporading capsules (hereinafter referred to as "the drug"), which is evaluated consistently by generic drugs.
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FDA grants Zenotuzumab 'fast track qualification' to treat NRG1 gene fusion tumors
Time of Update: 2021-01-16
Merus is currently recruiting patients for Phase I/II clinical trials aimed at evaluating the effectiveness of Zenocutuzumab's single-drug treatment of pancreatic cancer and other solid tumors that are fusion of the NRG1 gene.
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The fourth batch of national drug collection officially started! 90 dosage forms shortlisted
Time of Update: 2021-01-01
Enterprise requirements belong to the scope of this drug declaration and meet the drug requirements of the relevant enterprises, including: the provision of drugs and accompanying services of domestic pharmaceutical production enterprises, drug market licensing holders, overseas production enterprises in Chinese mainland set up or designated and can bear the corresponding legal responsibility of the representative body or corporate legal person.
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Yingpai Pharmaceutical Baojun: From BD Leader to CEO
Time of Update: 2020-11-30
In October 2018, Yingpai Pharmaceuticals officially announced the appointment of Dr. Bao Jun as CEO, in order to promote the company's domestic and foreign business development, the news came out, causing strong concern in the industry, many people are as curious as I am: what makes this habitual BD master, willing to take on the burden, become a company's helm?
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The drug company's second IPO will see three of its heavyweight products go on the market
Time of Update: 2020-11-10
, the stroke treatment drug Idalafon compound preparation is expected to become the world's first approved new stroke drug for sale in nearly five years.
