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CGT therapy: commercialization in China is imminent
Time of Update: 2022-08-15
2 million yuan On June 22, 2021, the China National Medical Products Administration (NMPA) approved the launch of Fosun Kite's new CAR-T cell therapy drug Yijilirenxai Injection (also known as Akiloxet, R&D code: FKC876) .
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$234 million!
Time of Update: 2022-08-15
5 million in technology transfer fees and potential payments of up to $164 million in development, registration and sales-based commercialization milestones Endometriosis refers to the endometrial cells that should grow in the uterine cavity.
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The alliance of 13 provinces in Henan concentrated procurement, continued to bargain prices, continued to allocate procurement volume, and got another 50% from the lowest price
Time of Update: 2022-08-15
8 times or the decrease is not less than 50% (calculated based on the highest effective declared price of the varieties and specifications corresponding to the purchase variety catalog), the enterprises will be eligible to be selected in ascending order according to the effective quotations of the enterprises , until the maximum value is reached.
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$11.6 billion!
Time of Update: 2022-08-15
Biohaven's Neuroinnovation™ portfolio includes NURTEC® ODT (rimegepant), and a broad pipeline of late-stage product candidates across five different mechanistic platforms: CGRP receptor antagonists for acute and prophylactic treatment of migraine; glutamate-modulating The effects of obsessive-compulsive disorder and spinocerebellar ataxia.
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How to "go to Beijing to take the test" for a drug marketing authorization application?
Time of Update: 2022-08-15
Under the conditions of the implementation of the newly revised "Drug Administration Law", "Administrative Measures for Drug Registration" and "Measures for the Supervision and Administration of Drug Production", there are some issues worthy of attention and discussion in the submission, acceptance and review and approval procedures of marketing authorization applications .
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Suddenly changed!
Time of Update: 2022-08-15
On May 12, 2022, Australian biotech company CSL said it could not close the deal by June 2022 as previously expected, as regulators need additional months to review its acquisition of Vifor Pharma .
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A variety of class 1 new drugs welcome progress!
Time of Update: 2022-08-15
Since 2022, Qilu Pharma's innovative drugs have ushered in new progress: Today, the official website of the Center for Drug Evaluation (CDE) of China's State Drug Administration shows that Qilu Pharm
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Hengrui Fosun entered the global pharmaceutical R&D TOP25 for the first time, and Pfizer launched a major merger with US$11.6 billion. How can pharmaceutical companies save the pipeline bottleneck period?
Time of Update: 2022-08-15
According to the "Pharma R&D Annual Review 2022 Navigating the Landscape" released by Informa Pharma Intelligence, as of January 2022, the number of new drug pipelines under research in the world exceeded 20,000 for the first time, reaching 20,109, an increase of 8.
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Fumbling forward: Inventory the upgrade path of ADC connectors
Time of Update: 2022-08-15
Although this ADC drug and the first-generation Mylotarg® both use cleavable linkers based on hydrazone bonds and disulfide bonds, However, it showed better plasma stability In 2017, the third-generation ADC drug Besponsa® was approved for marketing for the treatment of acute lymphoblastic leukemia.
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China's first new crown drug NDA is coming soon!
Time of Update: 2022-08-15
Image source: Minsheng Securities Research Report An international multicenter, double-blind, randomized, placebo-controlled, Phase II/III clinical study (NCT05242042) for mild to moderate COVID-19 was initiated in February this year to evaluate the use of VV116 in mild to moderate COVID-19 Efficacy, safety and pharmacokinetics of early treatment in 19 patients, the primary endpoint is the proportion of patients who converted to severe/critically ill COVID-19 and died from all causes within 29 days .
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4 models have been approved!
Time of Update: 2022-08-15
Mavacamten Developed by BMS, is the first FDA -approved small-molecule allosteric modulator of cardiac myosin that inhibits troponin-myosin binding and prevents muscle bridge formation, thereby improving myocardial contractility in patients with hypertrophic cardiomyopathy (HCM).
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Moderna Announces the Latest Advances in mRNA Technology Platform, Improved Delivery and Stability (with PPT)
Time of Update: 2022-08-15
Image source: Moderna's official website The company's research points to the need to use different means to reduce adduct formation during the production of mRNA-carrying LNPs, which could lead to multiple benefits, including improved product shelf life and the ability to store products at higher temperatures, And maintain product activity and consistency between manufacturing batches .
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Innovative drug emerging track, water sellers are ready to go
Time of Update: 2022-08-15
This makes CDMO companies need to fill in the shortcomings of each piece and become an integrated company In addition, we know that the entire cell gene therapy industry has many sub-fields, AAV (adeno-associated virus), lentivirus, adenovirus, oncolytic virus in cell gene therapy; CAR-T, CAR-NK in cell therapy, involving To solid tumors, universal cell therapy, etc.
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Annual Analysis of Pharmaceutical R&D Trends in 2022
Time of Update: 2022-08-15
. "Different from Hengrui's independent research and development, the expansion of Fosun's drug pipeline mainly relies on the introduction of drug technologies from partners, including the introduction of BioNTech SE's mRNA new crown vaccine technology," said Ian Lloyd, senior director of Pharmaprojects, in the "2022 Annual Pharmaceutical R&D Trends Year".
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Express Hemophilia B Gene Therapy Receives FDA Priority Review, Reduces Annual Bleeding Rate by 64%
Time of Update: 2022-08-15
S. Food and Drug Administration has accepted the company's Biologics License Application (BLA) for the company's investigational gene therapy etranacogene dezaparvovec for the treatment of adults with hemophilia Today, CSL Behring announced that the U.
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There is a cure!
Time of Update: 2022-08-15
Zhijiang Bio said at the performance briefing that the company's monkeypox virus nucleic acid detection kit has recently received orders from Portugal, Spain, the Czech Republic, the United Arab Emirates and other overseas countries, as well as some domestic customs, disease control emergency reserves and scientific research.
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New crown prevention and control trilogy (part 2) - Inventory of global new crown oral drug research and development progress
Time of Update: 2022-08-15
The drug is the world's first new oral drug approved for the treatment of mild to moderate adult patients On November 26, 2021, Merck announced the phase III clinical data of monupavir, which showed a 30% reduction in the risk of hospitalization/death (6.
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TOP 1-8 Foreign companies all in, domestic pharmaceutical companies follow?
Time of Update: 2022-08-15
Amelox, generic name Ametinib mesylate, a class 1 innovative drug independently developed by Hansoh Pharmaceuticals , approved by the State Drug Administration for marketing on December 16, 2021, for those with EGFR exon 19 deletion Indication for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for an exon 21 (L858R) substitution mutation .
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Professor Chen Yao: Real-world research from the eyes of a statistician
Time of Update: 2022-08-15
Yao Chen, director of the Medical Statistics Office of Peking University First Hospital, "How to use high-quality real-world data research to break the circle" There are a thousand Hamlets in the eyes of a thousand people.
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Traditional VS Freshmen: Who Qualifies as an Innovative Pharmaceutical Company?
Time of Update: 2022-08-15
The Q1 sales and year-on-year growth rates of a total of 11 pharmaceutical companies in 2022 are shown in Table 1: From the perspective of data, analyze the competitive landscape and product power of mainstream pharmaceutical companies .
