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Facing the patent cliff: BMS, Amgen and Pfizer are all in response, Bojian may be acquired
Time of Update: 2022-02-22
S. and Europe, Bristol-Myers Squibb, Amgen and Pfizer will face generic or biosimilar competition for most of their revenue in 2025, and the patent cliff will lead to related product revenue also falling will drop rapidly .
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Olumiant and sotrovimab are recommended by WHO to treat COVID-19
Time of Update: 2022-02-22
The first drug is Eli Lilly's JAK inhibitor Olumiant (baricitinib), which is highly recommended for the treatment of severely ill patients with COVID-19 .
The second drug, GlaxoSmithKline/Vir's monoclonal antibody sotrovimab, is conditionally recommended for the treatment of patients with mild or moderate COVID-19 who are at high risk for hospitalization .
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FDA Grants Fast Track Designation for ATRS-1902 for Adrenal Crisis Rescue
Time of Update: 2022-02-22
Just recently, Antares Pharma announced positive results from a phase I crossover study of ATRS-1902, which met its primary endpoint: In 32 healthy adults, ATRS-1902 (100 mg) provided a synergistic effect with reference drug Solu Cortef® ( 100 mg) comparable pharmacokinetic profile .
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Behind 95% of "soul bargaining", explain in detail the five major bargaining logics of the National Medical Insurance Bureau
Time of Update: 2022-02-22
Zheng Jie, the leader of the National Medical Insurance Negotiation Drug Fund Calculation Expert Group, explained that the threshold of 300,000 yuan for annual treatment costs is not artificially set, but calculated.
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Innovative drugs: obtain implied clinical license, please pay attention to ICH-E series
Time of Update: 2022-02-21
1 DSUR scope and related content requirements ➣ "E2F: Example of Security Update Report During R&D" ICH-E2F, DSUR example for species ZB3579 tranche 4 annual report summarizing the safety data received by Zoboryn Pharmaceuticals from January 1, 2009 to December 31, 2009 .
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Fungibility: A competitive bargaining chip for biosimilars?
Time of Update: 2022-02-21
These past experiences reflect the FDA's confidence in the safety and efficacy of biologics after production changes, and to a certain extent lay the foundation for proving that the so-called originator drugs (first-generation products) are "same" as biosimilars .
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The awakening time of the original innovative drug
Time of Update: 2022-02-21
Today, we will talk about the characteristics of new drug research and development that are different from other industries for your reference .
The evaluation of new drug projects needs to balance a variety of factors.
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"Super dark horse" Rongchang Bio is about to launch A+H. What is the internal engine?
Time of Update: 2022-02-21
70% in R&D investment Rongchang Bio is a global innovative biopharmaceutical company established in July 2008, focusing on the discovery, development and commercialization of therapeutic antibody drugs such as antibody drug conjugates, antibody fusion proteins, monoclonal antibodies and double antibodies .
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The 170 billion market will explode!
Time of Update: 2022-02-21
After the traditional Chinese medicine formula granules get rid of the "pilot" restrictions, the number of enterprises participating in R&D and production will increase, the scope of use will also expand, and the industry will usher in a period of rapid growth .
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The new policy of guiding principles is introduced, and the future of rare disease drugs is coming
Time of Update: 2022-02-21
Figure 1 Market breakdown of rare disease drugs (unit: USD 1 billion) Data source: Beihai Kangcheng’s prospectus, Rost & Sullivan analysis (2021 and beyond are forecast data) Rare disease drugs have a high success rate in drug development .
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Review of major pharmaceutical policies in 2021
Time of Update: 2022-02-21
The proportion of pharmaceutical policy classification in 2021 Source: Collation of public information From the perspective of the policy issuing department, the State Food and Drug Administration (including the Drug Evaluation Center) issued the largest number of policies, followed by the Health and Health Commission and the Medical Insurance Bureau .
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In 2021, the national registered drug clinical trial overview will increase by 29.11%!
Time of Update: 2022-02-21
11% compared with 2020!Drug clinical trials registered in 2021 increased by 29.
Investigator ranking changesInvestigator ranking changes The top three principal investigators who will undertake the most clinical trials of newly registered drugs in 2021 are Prof.
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Daiichi Sankyo spins off 8 cardiovascular drugs and shifts focus to oncology portfolio
Time of Update: 2022-02-21
During a 30-month transition period, Daiichi Sankyo will transfer the manufacturing, supply and commercialization of the product to Cosette .
For Cosette, taking over the deal for Daiichi Sankyo's eight cardiovascular drugs will be a springboard for its inward and outward development in the business .
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70% of the price is reduced for 70% of the purchase volume. Can Changchun Hi-Tech, whose stock price "flash crash" under centralized procurement, still hold up?
Time of Update: 2022-02-21
Judging from the volume of reports, whether it is Changchun High-tech or Anke Bio, the impact of Guangdong Alliance's centralized procurement on the performance of growth hormone companies is limited .
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CDE Weekly Report on the Number of Improved New Drug Marketing Applications Sudden Increase!
Time of Update: 2022-02-21
Autologous CAR-T cell immunotherapy product of biologics Ruiki Aurenzai injection CD19 Among the list of improved new drugs undertaken this time, 8 are applications for marketing registration , and only 2 are applications for clinical trials .
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Data In December 2021, China, the United States and Europe approved 25 new drugs for marketing
Time of Update: 2022-02-21
The drug is indicated for the first-line treatment of patients with epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase (ALK)-negative metastatic non-squamous non-small cell lung cancer in combination with pemetrexed and carboplatin.
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China Pharmaceutical Promotion Association 2021-end inventory series three: ten keywords in the pharmaceutical industry
Time of Update: 2022-02-21
The national centralized procurement in 2021 has covered 218 drugs and high-value medical consumables that are most widely used clinically and have the highest sales in China, and is continuing to expand.
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18 large international pharmaceutical companies with 1.72 trillion US dollars, will mergers and acquisitions explode in 2022?
Time of Update: 2022-02-21
S. pharma and life sciences consulting solutions leader, said 2022 could be a "pretty active year" for biopharma M&A, not just because Big Pharma amassed a lot of cash, but also because pharma companies The need to scale and diversify across different therapeutic areas remains evident .
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What are the new drugs approved by the FDA in 2021?
Time of Update: 2022-02-21
Summary of CDER Approved Drugs in 2021 Additional additions to further approvals by the FDA's Center for Biologics Evaluation and Research (CBER) include landmark mRNA vaccines and CAR-T cell products (Table 2) .
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TOP25 Targets of Medical Rubik's Cube Translational Medicine in 2021
Time of Update: 2022-02-21
The selection criteria are mainly divided into 3 objective Dimensions: 1) A new target with clinical translation value confirmed for the first time; 2) A target that has passed clinical POC verification for the first time; 3) The target has a new breakthrough in project development or indication .