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Exploration and Thoughts on the Price Formation Mechanism of Innovative Drugs
Time of Update: 2021-10-21
Through national talks, the price reduction of innovative drugs to achieve medical insurance access and speed up the commercialization process is of great significance for improving accessibility .
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Hebo Pharma FcRn antibody enters the third clinical phase!
Time of Update: 2021-10-21
Reduce pathogenic antibodies and suppress immunity The most commonly used drug among cholinesterase inhibitors is brompistigmine, which is the first-line drug for the treatment of all types of MG, which can alleviate and improve the clinical symptoms of most MG patients .
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Groundbreaking research on the mechanism of type 1 diabetes therapy yields positive results, GK agonist TTP399 does not increase the risk of ketoacidosis
Time of Update: 2021-10-21
On October 12, vTv Therapeutics announced that the study of the mechanism of TTP399 in the treatment of type 1 diabetes has obtained positive results, proving that patients with type 1 diabetes who received TTP399 did not have an increase in keto acid levels during the withdrawal of insulin treatment compared with the placebo group, which means that TTP399 does not Increase the risk of ketoacidosis .
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Notice on Publicly Soliciting Opinions on the "Technical Guidelines for the Design of Clinical Trials of Long-acting Granulocyte Colony Stimulating Factor Preventing Infection after Chemotherapy (Draft for Solicitation of Comments)"
Time of Update: 2021-10-21
docx "Long-acting Granulocyte Colony Stimulating Factor Clinical Trial Design Technical Guidelines for the Prevention of Infection after Chemotherapy (Draft for Solicitation of Comments)" feedback form for soliciting opinions.
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The first domestically produced new crown neutralizing antibody combination therapy is coming!
Time of Update: 2021-10-21
The results show that compared with placebo, the BRII-196/BRII-198 combination therapy makes clinical progress to be severe Outpatients with COVID-19 at high risk of disease have a 78% reduction in the risk of hospitalization and death, which is statistically significant, and its safety is better than placebo .
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Class 1 new Chinese medicines welcome the blowout, Renfu, Kangyuan...12 blockbuster sprints are on the market!
Time of Update: 2021-10-21
Kun Yining Granules Suxia Jieyu Chufan Capsules Table 2: Status of Class 1 New Drugs Approved for Clinical Trials from 2020 Source: CDE official website, Minet database Note: Some indications are compiled through public information Since 2020, a total of 39 Chinese patent medicines have been applied for clinical application of Class 1 new drugs.
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Merck, Bayer, Novartis and others are optimistic about whether STING can become a "dark horse" in the field of immunotherapy?
Time of Update: 2021-10-21
In view of these findings, the STING signaling pathway has become a promising target for researchers to develop new therapies for the treatment of cancer and inflammatory diseases .
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Over 450 million US dollars: Hausen introduces siRNA therapy for liver disease
Time of Update: 2021-10-21
As part of the cooperation agreement, the two companies will use OliX Pharmaceuticals’ GalNAc-asiRNA platform and Hansen Pharmaceuticals’ strong R&D, production and commercialization capabilities in China to develop multiple hepatocyte-targeted products, involving Areas include cardiovascular, metabolic and other indications .
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New drug for super rare diseases: FDA approves Rethymic to treat congenital athymic children
Time of Update: 2021-10-21
Recently, the US Food and Drug Administration (FDA) approved Enzyvant Sciences' Rethymic (Allogeneic Treated Thymus Tissue-agdc) for the treatment of congenital athymic children .
Rethymic therapy is the result of more than 25 years of research aimed at improving the survival rate of children who had little hope of treatment before .
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Thinking about how to solve the dilemma of setting medical insurance payment standards caused by multiple indications?
Time of Update: 2021-10-21
At this time, how should the medical insurance payment standard be formulated: Is it differential pricing for different indications, or is it a comparison of prices for different indications that are higher or lower, or lower or higher, or is it weighted average based on the number of drugs used?
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Children's medication: Hengrui "Cyclophosphamide Capsules" plans to be reviewed first, the first domestic product
Time of Update: 2021-10-21
A total of 10 injection products have been approved for marketing, but only 1 Hengrui has just passed the consistency evaluation on September 23, and no other companies have started the consistency evaluation work .
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Johnson & Johnson's CD38 monoclonal antibody subcutaneous injection formulation was approved in China, greatly shortening the administration time
Time of Update: 2021-10-21
from https:// [2] US Food and Drug Administration Approves DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma.
com/us-food-and-drug-administration-approves-darzalex-fasprotm-daratumumab-and-hyaluronidase-fihj-new [3] Genmab Announces Positive Topline Results in Phase III ANDROMEDA Study of Daratumumab in Light-chain (AL) Amyloidosis.
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The first-line clinical trial of the first-line treatment of advanced HCC in the treatment of advanced HCC with ALK-1 monoclonal antibody combined with O-drug of Kaixing Pharmaceutical was approved in China
Time of Update: 2021-10-21
On October 11, Kaifeng Pharmaceutical announced that the clinical trial of ALK-1 monoclonal antibody (GT90001C) combined with Nivolumab has been approved by the China National Medical Products Administration on October 9 for use in advanced hepatocytes without systemic treatment.
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Notice on Doing a Good Job in the Fifth Batch of National Organizations of Centralized Procurement and Use of Drugs in this Municipality
Time of Update: 2021-10-20
All district medical insurance bureaus, health committees, all non-profit medical institutions, medical insurance designated medical institutions, and all relevant pharmaceutical production and opera
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The first in China!
Time of Update: 2021-10-20
2, TJ-CD4B can still bind to tumor lesions and produce better immune activity than other 4-1BB monoclonal antibodies .
In July 2018, Tianjing Biotech authorized the development and commercialization rights of TJ033721 outside the Greater China region to South Korea’s ABL Bio.
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The US$4.2 billion cooperation is terminated, and the R&D of Merck's dual antibodies is renewed!
Time of Update: 2021-10-20
By March of this year, the phase II INTR@PID BTC 047 of M7824 used alone for the second-line treatment of locally advanced or metastatic biliary tract cancer (BTC) failed to reach the primary endpoint again, and the clinical trial was terminated again .
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2018~2020 Annual Report of Drug Review: Using review resources for new drugs with clinical value, regulatory observations
Time of Update: 2021-10-20
Kong Fanpu, director of the Drug Evaluation Center of the State Drug Administration, said in an interview with the Pharmaceutical Economic News that in recent years, limited review resources have been used in drug review and approval for innovative drugs with obvious clinical value and urgently needed drugs.
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Announcement of the Center for Drug Evaluation of the State Food and Drug Administration on the issuance of the "Technical Guidelines for Clinical Trials of Anti-HIV Infection Drugs" (No. 41 of 2021)
Time of Update: 2021-10-20
Attachment: Technical guidelines for clinical trials of anti-HIV infection drugs National Food and Drug Administration Center for Drug Evaluation October 11, 2021 Relevant attachments 1.
Technical guidelines for clinical trials of anti-HIV infection drugs.
pdf Technical guidelines for clinical trials of anti-HIV infection drugs.
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The U.S. government encourages the expansion of domestic production capacity for single-use vaccine and drug production systems
Time of Update: 2021-10-20
” On October 7, BARDA announced a request for government funding to expand domestic production of disposable bags, pipes, and related components to support the new crown vaccine in a public health emergency.
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Zhengda Tianqing's Polymyxin E Sodium Methanesulfonate for Injection Approved
Time of Update: 2021-10-20
On October 13, the official website of China National Food and Drug Administration (NMPA) announced that Chia Tai Tianqing, a subsidiary of China National Biopharmaceutical Corporation, had submitted its "polymyxin E sodium methanesulfonate for injection" listing application submitted under the registration category 3 category .