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The first FDA approved pericarditis therapy! IL-1 inhibitors are expected to change the treatment paradigm
Time of Update: 2021-03-27
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 https:// Kiniksa-Announces-FDA-Approval-of-ARCALYST-rilonacept-for-Recurrent-Pericarditis.
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Roche's PD-L1 antibody Tecentriq in the Phase 3 clinical trial of NSCLC patients reached the primary endpoint
Time of Update: 2021-03-27
On March 22, Genentech, a subsidiary of Roche, announced that its PD-L1 antibody Tecentriq (atezolizumab, atelizumab) will be used for the treatment of early stage non-small cell lung cancer (NSCLC) patients in Phase 3 clinical trials.
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Enhua Pharmaceutical Announces Consistency Evaluation Announcement for Aripiprazole Tablets
Time of Update: 2021-03-27
On March 18, Enhua Pharmaceuticals announced that the company recently received the "Aripiprazole Tablets" approved and issued by the State Food and Drug Administration "Drug Supplementary Application Approval Notice", approving the drug to pass the quality and efficacy of generic drugs Consistency evaluation.
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An Ping joins Organon as the head of cardiovascular sales
Time of Update: 2021-03-27
On March 15th, Shi Wang, the head of Organon China, announced that An Ping would join the company from now on, serving as the National Senior Sales Director of Cardiovascular Product Line of the Classic Brand Hospital Division.
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Eli Lilly appoints Jiang Yifei as Vice President of New Diabetes Products Division
Time of Update: 2021-03-27
On March 17, Eli Lilly officially announced that Chen Jun, the current Vice President of Eli Lilly’s China Diabetes Products Division, will leave Eli Lilly for personal reasons to seek external career development opportunities.
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Chinese medicine is frequently difficult for companies to return goods
Time of Update: 2021-03-27
Where is the way to improve the quality of traditional Chinese medicine products and avoid excessive levels of 33 pesticide residues?In recent years, the government has given great support to the development of the Chinese medicine industry, and good news continues.
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A wholly-owned subsidiary of Tus Pharmaceuticals obtained the "Drug Production License"
Time of Update: 2021-03-27
The solid comprehensive preparation workshop and comprehensive extraction workshop production line involved in some of the fund-raising projects implemented by the Chinese Medicine Company have passed the on-site inspection of drug GMP compliance by the Hunan Provincial Drug Administration, and completed the modification record of the "Drug Production License".
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Nefecon, a new drug for primary IgA nephropathy, applies for listing in the United States!
Time of Update: 2021-03-27
The Swedish biopharmaceutical company Calliditas Therapeutics recently announced that it has submitted a new drug application (NDA) for Nefecon (budesonide) to the US Food and Drug Administration (FDA), a new oral formulation that targets down-regulation of IgA1 for the treatment of primary IgA.
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The heads of the Ministry of Justice, the State Administration of Market Supervision, and the Food and Drug Administration answer questions from reporters on the Regulations on the Supervision and Administration of Medical Devices
Time of Update: 2021-03-27
Question: In 2017, the Central Office and the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices", proposing to promote the full implementation of the marketing authorization holder system.
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Pfizer's PF-06882961 clinical trial application was approved for the treatment of type 2 diabetes
Time of Update: 2021-03-27
Danuglipron (code name: PF-06882961 tablets) is an oral small molecule GLP-1 receptor agonist developed by Pfizer.
The company will also initiate a phase IIb clinical trial to test the efficacy of this oral small molecule GLP-1 receptor agonist in the treatment of patients with NASH.
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Vertex begins Phase 1/2 clinical trial of VX-880 experimental treatment
Time of Update: 2021-03-27
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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Delaying COVID-19 surgery for seven weeks can reduce the risk of death
Time of Update: 2021-03-26
China News Service, Hong Kong, March 23 (Reporter Han Xingtong) The Chinese University of Hong Kong (CUHK) announced on the 23rd that a joint study by CUHK and overseas surgical experts found that if a patient diagnosed with new coronary pneumonia undergoes surgery within six weeks after diagnosis, they will Increasing the risk of postoperative death, research suggests that the operation should be postponed to the seventh week or later after diagnosis.
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Zhejiang's drug access "opens the gate", opportunities for many large varieties are coming
Time of Update: 2021-03-26
List of certain commercial insurance: Medical Network News, March 25, Zhejiang Province has been relatively tight on product access cards since the 2014 standard.
List of certain commercial insurance: Medical Network News, March 25, Zhejiang Province has been relatively tight on product access cards since the 2014 standard.
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Eli Lilly’s business model adjustment for multinational pharmaceutical companies has a large number of drugs "patent cliff" here?
Time of Update: 2021-03-26
The CCO mixed line team is cancelled, what will happen to the patent expired drugs?In addition, in the email, Eli Lilly also stated, “During the business transformation and adjustment at the end of last year, based on the uncertain factors of the three products (Xinbaida, Cialy, and Futai), in order to smooth the business transition and explore uncertainties.
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The most compact superconducting cyclotron proton therapy system was successfully developed
Time of Update: 2021-03-26
Schematic diagram of the most compact domestically produced superconducting cyclotron proton therapy system (data picture) As a new type of radiotherapy technology, proton therapy has the advantages of good therapeutic effect, small side effects, and quick recovery of patients.
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Yuan Dong, Ted...The siege surged by 300% injections! Osaikon is here too
Time of Update: 2021-03-26
0 Chinese Drug Evaluation Database In recent years, with the efforts of domestic pharmaceutical companies, AbbVie's paricalcitol injection market share has declined rapidly, from its monopoly in 2017 to less than 20% in the first half of 2020.
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Yuan Dong, Ted...The siege surged by 300% injections! Osaikon is here too
Time of Update: 2021-03-26
0 Chinese Drug Evaluation DatabaseIn recent years, with the efforts of domestic pharmaceutical companies, AbbVie's paricalcitol injection market share has declined rapidly, from its monopoly in 2017 to less than 20% in the first half of 2020.
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Hebei Province: Strengthening the supervision and inspection of medical expenses and prohibiting large prescriptions
Time of Update: 2021-03-26
Standardize the interactive process of doubtful points—strengthen the effect of agreement clauses and indicator constraints, and include priority use of medical insurance catalog drugs (medical consumables), control of the proportion of self-pay, prohibition of inducing drugs to be purchased out of hospitals, and issuing large prescriptions in violation of regulations, etc.
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The State Food and Drug Administration Revises the Instructions for Mouse Nerve Growth Factor for Injection
Time of Update: 2021-03-26
On March 23, the State Food and Drug Administration issued an announcement on the revision of the instructions for mouse nerve growth factor for injection, and decided to revise the instructions for mouse nerve growth factor for injection [adverse reactions], [precautions] and medications for special populations.
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The State Food and Drug Administration revises the instructions for systemic fluoroquinolones
Time of Update: 2021-03-26
Add the following content under [Notes] Risk of aortic aneurysm and aortic dissection Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
