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Zhang Lianshan: Innovation is everywhere, don't worry about being compared with others｜Jianghu
Time of Update: 2022-02-20
Zhang Lianshan: For traditional pharmaceutical companies, we have no basis for innovation, and we need to make up our minds to change systems and concepts and invest real money in research and development .
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19 new varieties have passed the consistency evaluation, and 2 are the first ones (list attached)
Time of Update: 2022-02-20
In December 2017, Hengrui submitted the drug's marketing application, which took 4 years to review and was finally approved for marketing .
In September 2019, Beijing Hanmi Pharmaceuticals took the lead in submitting a new category 3 generic drug application for amlodipine and losartan potassium tablets (I).
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The new model of domestic BD!
Time of Update: 2022-02-20
According to some existing basic research of Eli Lilly and its knowledge and experience in related diseases, targets and drug discovery, Heyu Pharma will lead the development from lead compounds to PCC clinical trials.
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U.S. Department of Health appeals drug discount program ruling in federal court
Time of Update: 2022-01-27
In December 2020, HHS issued an advisory in response to drugmakers stating that businesses are obligated to offer discounts even when hospitals and clinics use contract pharmacies to deliver drugs .
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Nature: FDA-approved new drug inventory and sales forecast in 2021
Time of Update: 2022-01-27
50 new drugs approved by CDER in 2021 Note: a: biological products; b: withdrawn from the market; The FDA's Center for Biologics Evaluation and Research (CBER) also approved landmark mRNA vaccines and CAR-T cell products, and granted Emergency Use Authorization (EUA) for antibodies and rapidly developing oral antivirals to treat COVID-19 .
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How much has the national procurement changed the pattern of the pharmaceutical market?
Time of Update: 2022-01-27
5%; The proportion of unselected generic drug purchases decreased by 37%, the largest decrease was omeprazole, which decreased by 69%, and the smallest decrease was imatinib, which decreased by only 2.
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The 41st batch of "Pass Consistency Evaluation" list is here
Time of Update: 2022-01-26
4% 249 varieties that have reached 3 through enterprises 63 injections that have passed through 3 companies Data statistics are as of August 31st, and Insight will publish the varieties and other trends that have passed the consistency this month on a monthly basis.
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The National Health and Health Commission requires that information such as consumables prices, equipment procurement and other information be fully disclosed
Time of Update: 2022-01-26
The "Measures" stipulate that medical and health institutions should take the initiative to disclose the following information according to their own characteristics and their actual service conditions: 1.
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[Yaokajun] Chinese medicine broke out again!
Time of Update: 2022-01-26
What to watch this week Urothelial cancer welcomes its first ADC A variety of new anti-infective drugs are reported to usher in new progress BeiGene PD-1 Approved for the 6th Indication Jianmin Pharmaceutical's Qirui Weishu Capsule was approved for listing In this issue (January 1st to January 7th), Hengrui Medicine has obtained two innovative drugs, Vidicitumumab and Tislelizumab have been approved for a new indication respectively, and innovative traditional Chinese medicine drugs have once again been approved.
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Hengrui Medicine introduced over 100 million US dollars!
Time of Update: 2022-01-26
03, 2021, from https:// home/20211103005162/en[2] Mycovia Pharmaceuticals Announces Completion of Partner Jiangsu Hengrui Pharmaceuticals' Phase 3 Clinical Study Evaluating Oteseconazole for Treatment of Acute Vulvovaginal Candidiasis (VVC) in China Retrieved Nov.
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34 new varieties have passed the consistency evaluation, and 8 are the first ones (list attached)
Time of Update: 2022-01-26
In October 2019, Jianjin Pharmaceutical submitted a generic drug listing application for calcium levofolinate for injection (new category 3); in August of the same year, it was included in the priority review process by CDE on the grounds of "encouraging drug innovation"; in January 2022, This product has been approved by NMPA for listing, and it is the first domestic product that has been deemed to have been reviewed .
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Inventory of the progress of new crown drug research and development in 2021
Time of Update: 2022-01-26
Yaodu took stock of the current research and development/approval of small molecule antiviral drugs and new coronavirus neutralizing antibodies , and shared them with you .
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[Nature Sub-Journal] Review of FDA-Approved Drugs in 2021
Time of Update: 2022-01-26
The FDA has approved 50 new drugs in 2021 , including the first KRAS inhibitor for cancer and the first anti-amyloid antibody therapy for Alzheimer's disease .
Small Molecule Kinase Inhibitors Alzheimer's disease The FDA approved Biogen and Eisai's amyloid beta-lowering antibody aducanumab in the most controversial decision of the year .
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Merck's first in class cytomegalovirus infection new drug "Letermovir" approved in China
Time of Update: 2022-01-26
Cytomegalovirus (CMV) seropositive adult recipients [R+] for allogeneic hematopoietic stem cell transplantation (HSCT) to prevent CMV reactivation and disease .
Letermovir was first approved by the FDA in November 2017 for the prevention of CMV infection in adult recipients of CMV IgG-positive Allo-HSCT .
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IQVIA predicts that global drug spending will reach $1.8 trillion in 2026
Time of Update: 2022-01-26
According to the report, driven by multiple factors such as COVID-19, increased drug consumption, new product launches, and brand drug patent expiration, the global Pharmaceutical spending will grow at a compound annual growth rate (CAGR) of 3%-6%, with global pharmaceutical spending expected to reach $1.
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FDA 2021 Biosimilar Approvals: Not Many, Many Firsts
Time of Update: 2022-01-26
Semglee is biosimilar and interchangeable with its reference biologic, Sanofi's Lantus (insulin glargine) .
The price of the brand interchangeable Semglee is closer to the reference product, with a WAC of $404.
-aqvh), and the total number of FDA-approved Humira competing products has reached 7 .
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Amgen reaches $1.9 billion partnership to rapidly develop innovative protein therapeutics through artificial intelligence
Time of Update: 2022-01-26
References:References: [1] Amgen And Generate Biomedicines Announce Multi-Target, Multi-Modality Research Collaboration Agreement.
html[1] Amgen And Generate Biomedicines Announce Multi-Target, Multi-Modality Research Collaboration Agreement.
Retrieved January 6, 2022, from https:// multi-target-multi-modality-research-collaboration-agreement-301455157.
Retrieved January 6, 2022, from https:// -biobucks-deal-to-churn-out-up-to-10-multi-modality-drug[2] Amgen Chooses Generate In $1.
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Three major changes in medical insurance negotiation in 2021｜Annual
Time of Update: 2022-01-26
However, according to the emergency notice issued by the National Medical Insurance Bureau recently, the 67 new negotiated drugs required in 2021 should be included in the "dual channels" of each province in principle .
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On January 7th, CDE issued 5 more clinically relevant guidelines, involving innovative drugs, improved new drugs, and traditional Chinese medicines. A total of nearly 20 were released this week!
Time of Update: 2022-01-26
Annex: Technical Guidelines for Drug Nonclinical Dependence Research Drug Evaluation Center of the State Food and Drug Administration January 4, 2022 Under the deployment of the State Drug Administration, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for the Study of Samples for Toxicology Research of New Chinese Medicines (for Trial Implementation)" (see attachment) .
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CDE issues 11 guidelines covering clinical trials, chemical generics, etc.
Time of Update: 2022-01-26
68) In order to encourage the research and development of new drugs, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized and formulated the "Guidelines for Writing a "Clinical Risk Management Plan" (for Trial Implementation)" (see attachment) .
