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UK MHRA summarizes clinical trial experience during the new crown epidemic
Time of Update: 2022-03-06
Topics covered in these guides include: Remote monitoring program deviation Remote access to electronic health records (EHR) and instructions for pausing trials Guidance on Minimizing Interference with the Conduct and Reliability of Drug Clinical Trials During COVID-19 challenges and lessonschallenges and lessons MHRA's Clinical Trials Unit challenges Clinical Trials Unit (CTU) COVID-19 reviewers to develop new ways of working to evaluate and approve trials in less time, while maintaining a consistently high level of Scientific and regulatory reliability .
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The seventh batch of new developments in national procurement!
Time of Update: 2022-03-06
The specific notice is as follows: At the same time, the official released the scope of drug reporting, including 208 product specifications: According to the past rhythm, after the enterprise information is filled in, the final document of centralized procurement and the on-site quotation are coming soon .
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The bottleneck problem that shackles WuXi Biologics, the opportunity for domestic manufacturers to explode!
Time of Update: 2022-03-06
It is foreseeable that everyone is preparing an emergency list to replace US suppliers to prevent emergencies; at the same time, downstream pharmaceutical companies will be more More consideration should be given to purchasing domestic bioreactor equipment, parts and related consumables .
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10 charts in the monthly report, a quick overview of the latest approvals of global pharmaceutical devices in January
Time of Update: 2022-03-06
Table 4: Three types of innovative devices approved for marketing in January 2022 Source: National Center for Medical Device Evaluation As of February 15, 2022, in January 2022, the State Administration approved a total of 175 Class III medical device products for the first registration, of which 152 were domestically produced and 23 were imported .
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In 2022, 6 drugs have launched 4.1 category patent challenges!
Time of Update: 2022-03-06
1 category patent declarations from 2022 to the present involve a total of 6 drugs , namely: Nanjing Hailing Pharmaceutical Edoxaban, Haichang Biological Albumin Paclitaxel, CSPC Mirabegron, Hainan Herui Pharmaceutical Dato Mycophenolate, Chia Tai Tianqing Everolimus and Regorafenib of Sichuan Kelun Institute of Pharmaceutical Sciences .
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Analysis of China's innovative drug IND trends
Time of Update: 2022-03-06
Among the new drugs that will apply for IND for the first time in 2021, due to the explosion in the number of double antibodies, the popularity of PDL1, TGF-β, 4-1BB, CD47 and other target combinations has also increased rapidly, and the targets of small molecule drugs are concentrated in KRAS G12C, BTK, SHP2, TOP15 target related drugs totaled 155, accounting for 25% .
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Kelun and Hengrui launched the seventh batch of antithrombotic class 1 new drugs, which have entered the reporting stage
Time of Update: 2022-03-06
Table 2: Changes in the market share of antithrombotic drugs that have been included in the national procurement earlier Source: Minet.
com China's public medical institutions terminal competition pattern Since the fourth batch of national procurement, antithrombotic injections have been included, and the seventh batch has also targeted 3 blockbuster injections.
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Hengrui's new drug R&D pipeline revealed!
Time of Update: 2022-03-06
Table 3 The main product layout of Hengrui Medicine in the field of breast cancer in clinical and market stageTable 3 The main product layout of Hengrui Medicine in the field of breast cancer in clinical and market stage Source: Hengrui official website Long and short-acting multiple coverageLong and short-acting multiple coverage Hengrui's chronic disease treatment covers metabolic diseases, cardiovascular diseases, respiratory diseases, autoimmune diseases, pain management, bone metabolism, etc.
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It's about to usher in the launch period!
Time of Update: 2022-03-06
In response to the mismatch between light and heavy chains, bispecific antibody research and development companies have launched technical platforms for IgG and non-IgG double antibodies .
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WuXi is listed on the "sanctions" list, how to play the card of domestic CRO going overseas?
Time of Update: 2022-03-06
In 1999, Li Ge, who is well-known in the field of global pharmaceutical and medicinal chemistry, returned to China to investigate and found that although domestic pharmaceutical research institutions already have certain R&D capabilities in the field of original research drugs, advanced production technology is still in the hands of foreign pharmaceutical companies.
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Looking back on 2021｜Drug supervision modernization has taken more solid steps
Time of Update: 2022-03-06
The platform integrates the registration and filing of cosmetics and new cosmetic raw materials, realizes the unified management of basic information of enterprises, and connects with the online service hall and the national drug intelligence supervision platform, so as to facilitate the one-stop login and one-stop operation of cosmetics enterprises .
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How do new drugs for rare diseases enter medical insurance?
Time of Update: 2022-03-06
After learning about the changes of this new drug to patients and doctors, on February 7, the Scottish medical cost regulator SMC announced that Risprom Oral Liquid will be incorporated into the Scottish National Health Service (NHS) system .
com/news-posts/2022/02/11/evrysdi-available-soon-eligible-sma-patients-via-scotland-nhs/https://smanewstoday.
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24 companies "besieged" AZ's original research drug!
Time of Update: 2022-03-06
With the gradual advancement of consistency evaluation, the number of large varieties of over-rated generic drugs is increasing, which has also caused huge losses to original research drugs.
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The FDA changed its face two years after the domestic drug went out to sea: 80% of Chinese clinical research is not standard
Time of Update: 2022-03-06
On February 10, 2022, the US FDA held an online Oncology Drug Advisory Committee (ODAC) for the marketing application of the PD-1 antibody sintilimab jointly developed by Innovent and Eli Lilly .
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8 clinically in short supply drugs are purchased online!
Time of Update: 2022-03-06
According to the requirements of "full online negotiation", the purchase price of clinically in short supply drugs is negotiated by designated medical institutions and drug manufacturers independently .
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Director of FDA Pazdur issued another article!
Time of Update: 2022-03-06
In June 2021, the FDA's Oncology Center of Excellence (OCE) issued new draft guidance encouraging the inclusion of all patients with incurable cancers in cancer clinical trials , regardless of whether they have been previously treated with other regimens .
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Replaying the new crown era, those breakthrough therapeutic drugs that have to be said
Time of Update: 2022-03-06
This review article presents the most impactful breakthrough medical innovations in response to COVID-19, Ebola virus disease (EVD), heart disease, cancer, Alzheimer's disease, diabetes and malaria during the pandemic It has far-reaching significance and positive impact on human beings .
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Lilly to develop next-generation ADC therapeutics in $1.7 billion R&D partnership
Time of Update: 2022-03-06
Grant Eli Lilly exclusive rights to develop and commercialize antibody drug conjugates (ADCs) against Eli Lilly's selected targets using ImmunoGen's innovative camptothecin technology platform .
References:References: [1] ImmunoGen Announces a Global, Multi-Target License Agreement of its Novel Camptothecin ADC Platform to Lilly for Up to $1.
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Can Chinese medicine go overseas only to the United States?
Time of Update: 2022-03-06
As a major chemical country, China is not weak in the field of drug production, and global regulatory registration and clinical trials are the weakest link for Chinese medicine and medicine to go overseas, among which the weakest It is the ability of Chinese pharmaceutical companies to manage MRCT research, which is the relevant content of ICH E17 .
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Legend Bio's CAR-T clinical trial in the United States is suspended, and China's innovative drugs have a long way to go
Time of Update: 2022-03-06
"Marketing approval of its CAR-T product, Cedarquiorenza, delayed by FDA because "FDA needs more time to review information submitted by companies" In August 2020, Cidaki Orenza has already received the first batch of breakthrough therapy designations granted by the China Food and Drug Administration, but Legend Bio still decided to list in the United States first, and then submit a listing application to the Chinese regulatory authorities .
