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Renfu Medicine's Paracetamol and Oxycodone Sustained-Release Tablets Obtained the Approval Notice for Drug Clinical Trials
Time of Update: 2022-05-03
On February 10, Renfu Pharmaceutical announced that its holding subsidiary, Yichang Renfu, had recently received the "Drug Clinical Trial Approval Letter" approved and issued by the State Drug Administration for acetaminophen and oxycodone sustained-release tablets.
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The third domestic company: Jiahe Bio's "Infliximab" is about to be approved
Time of Update: 2022-05-03
Although it has been on the market in China for many years, the first infliximab biosimilar has just been approved in July 2021, from Taizhou Maibotec Pharmaceuticals .
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China Resources Shuanghe Clindamycin Phosphate Injection Passes Consistency Evaluation of Generic Drugs
Time of Update: 2022-05-03
In the domestic market, according to information from the State Food and Drug Administration, 73 clindamycin phosphate injections have been approved for marketing in mainland China, and 14 manufacturers (including Shuanghe Limin) have passed the consistency evaluation; According to online data, the total sales (terminal price) of clindamycin phosphate injection in the domestic medical market in 2020 is 309 million yuan, of which the top 5 companies in terms of market share are Jiangsu Dahongying Hengshun Pharmaceutical Co.
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Heart disease risk continues European Medicines Agency will step up scrutiny of all JAK inhibitors
Time of Update: 2022-05-03
The reason for the move is thought to be because the latest clinical trial results of rheumatoid arthritis drug Pfizer Xeljanz showed that patients receiving the therapy had an increased risk of heart disease, stroke and other problems, and even died after receiving Xeljanz treatment.
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Reduce the risk of death by 32.5%!
Time of Update: 2022-05-03
CompilenewbornIn a phase 3 clinical trial in patients with metastatic hormone-sensitive prostate cancer (mHSPC), the combination of androgen deprivation therapy (ADT) ) + chemotherapy (docetaxel), Bayer's new prostate cancer drug Nubeqa (darolutamide, darolutamide) + ADT + chemotherapy regimen reduced the risk of death by 32.
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Sichuan pharmaceutical company will win over $10 billion in anticoagulant drugs
Time of Update: 2022-05-03
A few days ago, Chengdu Baiyu Pharmaceutical entered the administrative examination and approval stage with its generic apixaban tablets, which were reported for production in Category 4, and is expected to become the second antithrombotic drug that has been reviewed by the company .
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Innovent and Reindeer Medical's BCMA CAR-T was granted "orphan drug" designation by the US FDA
Time of Update: 2022-05-03
In February 2021, IBI326's therapy for R/R MM has been included in the "Breakthrough Therapy Drug" category by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) .
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Included in the U.S. "UVL" list, WuXi Biologics responded urgently
Time of Update: 2022-05-03
S. Department of Commerce's Bureau of Industry and Security (BIS) released an updated "Unverified List (UVL)", which was made public on February 8 .
According to data, from 2017 to 2020, the total proportion of overseas revenue of major domestic CXO listed companies increased from 62.
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New regulations for Chinese medicine decoction pieces: pharmacies can be exempted from fines of 100,000
Time of Update: 2022-05-03
The Guangdong Food and Drug Administration stated in the document that when the moisture or weight loss on drying items of Chinese herbal medicines do not meet the regulations, whether it affects the safety and effectiveness of the drug, three situations are specifically considered:1.
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One injection of 13.5 million yuan may cure SMA, the most expensive drug in history will land in China
Time of Update: 2022-05-03
Yangcheng Evening News reporter Zhang HuaRecently, the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration announced that Novartis' AAV gene therapy drug Zolgensma (OAV101 injection) for the treatment of Spinal Muscular Atrophy (hereinafter referred to as "SMA") Drug clinical trial applications submitted in China have obtained implied permission for clinical trials .
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List of accelerated approval policies in other countries around the world
Time of Update: 2022-05-03
In order to narrow the gap with the review efficiency of mature regulatory agencies such as FDA and EMA, other countries around the world are also making efforts to build accelerated drug approval paths under agile regulatory systems (Table 1) .
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Synthetic lethal FIC encounters ineffective blockbuster drug IP will be besieged?
Time of Update: 2022-05-03
To sum up, the reason that the petitioner based on evidence 2 that claim 1 cannot be supported by the description cannot be established;The problem of inventive step, the solvent described in paragraph [0040] of the patent specification involved by the patentee and the crystallization method described in counter-evidence 1 to obtain olaparib solvate are not enough to prevent those skilled in the art from not using other methods and other methods.
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GSK Belimumab Approved in China for Systemic Lupus and Active Lupus Nephritis in Adults
Time of Update: 2022-05-03
In China, belimumab was approved for marketing through priority review in July 2019, and is suitable for active, autoantibody-positive adult patients with systemic lupus erythematosus who still have high disease activity on the basis of conventional treatment .
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Memantine Hydrochloride Sustained-Release Capsules, a subsidiary of Renfu Pharmaceutical Holdings Limited, obtained the drug registration certificate
Time of Update: 2022-05-03
com, in 2020, the sales of all formulations of memantine in the three major terminal public hospitals of cities, counties and townships in China will be approximately RMB 600 million.
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Zejing Pharmaceutical's KRAS G12C Inhibitor Launches Clinical Trials in China
Time of Update: 2022-05-03
According to the China Drug Clinical Trial Registration and Information Publicity Platform, Zejing Bio has initiated a Phase 1/2 clinical study of ZG19018 in the treatment of patients with advanced solid tumors with KRAS G12C mutation .
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Innovent PCSK9 monoclonal antibody reaches the end point of Phase 3 clinical trial and plans to launch
Time of Update: 2022-05-03
The results of the CREDIT-1 study showed that in Chinese non-familial hypercholesterolemia (non-FH) patients with high-risk/very high-risk cardiovascular risk, after 48 weeks of continuous treatment with each dose group of IBI306, low-density lipoprotein cholesterol (LDL- C) Compared with the baseline reduction level, there was a significant improvement compared with the placebo group (450 mg Q4W group: the least squares estimated between-group difference was -65.
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The Shenzhen Medical Insurance Bureau arrested 17 people involved in the case and reported AstraZeneca's insurance fraud incident
Time of Update: 2022-05-03
In August 2021, AstraZeneca found in an internal compliance inspection that a small number of employees in Shenzhen had tampered with or participated in tampering with patient test reports, suspected of defrauding medical insurance funds .
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China Antibody Pharmaceutical's IND application for anti-IL-17RB antibody accepted by FDA
Time of Update: 2022-05-03
(hereinafter referred to as "China Antibody Pharmaceuticals") announced that the company has submitted a new drug clinical trial application (IND) for the anti-IL-17RB monoclonal antibody SM17 to the US FDA, and has It has been accepted by the FDA and is intended to be developed for the treatment of asthma .
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Sinopharm Modern Cefixime Capsules and Cefaclor Dry Suspension Passed the Consistency Evaluation of Generic Drugs
Time of Update: 2022-05-03
Up to now, Sinopharm Zhijun has invested approximately RMB 27 million in R&D (unaudited) for the consistency evaluation of cefixime capsules (0.
Up to now, Sinopharm Zhijun has invested approximately RMB 22 million (unaudited) in research and development for the consistency evaluation of cefaclor dry suspension (0.
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The negative controversy of the JAK inhibitor continues, and its Opzelura is still a great success after the launch
Time of Update: 2022-05-03
Incyte Chief Executive Herve Hoppenot said Tuesday that the launch of Opzelura has been "extremely successful" so far, with the topical cream reaching nearly 19,000 patients in the fourth quarter after its official launch in mid-October, with 500 sales.
