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Bojian's genetic eye disease gene therapy phase 3 clinical trial failed
Time of Update: 2021-06-30
According to foreign media reports, Bojian announced on June 15 that its gene therapy titrepigene emparvovec in late-stage trials in patients with rare hereditary eye disease without choroidalemia failed to meet the primary and key secondary endpoints .
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Bojian AD treatment drug gosuranemab phase 2 clinical failure
Time of Update: 2021-06-30
The Phase 2 TANGO study of Gosuranemab is a 78-week double-blind, placebo-controlled, parallel-group trial to evaluate the safety of patients with MCI or mild AD caused by Alzheimer's disease (AD) in slowing clinical progression Sex and effectiveness, followed by a long-term extension of dose-blindness .
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Analysis: the interaction between raw materials and auxiliary materials
Time of Update: 2021-06-30
The physical or chemical interaction between the drug and excipients will affect the bioavailability and stability of the drug; (2) It can help us understand the possible reactions before determining the final dosage form; (3) The compatibility of raw and auxiliary materials is essential for IND declaration .
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Novartis Radioligand Endocyte Treatment of Prostate Cancer Phase 3 Clinical Trial Results Positive
Time of Update: 2021-06-30
The study was carried out in 831 patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) and evaluated the efficacy and safety of 177Lu-PSMA-617 combined with Best Standard of Care (SOC) and SOC alone .
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Nuocheng Jianhua announced the latest clinical data of the pan-FGFR inhibitor gunagratinib at the 2021 American Society of Clinical Oncology (ASCO) annual meeting
Time of Update: 2021-06-30
Biomedical high-tech company Nuocheng Jianhua (Hong Kong Stock Exchange code: 09969) today announced the latest clinical data of the pan-FGFR inhibitor ICP-192 (gunagratinib) at the 2021 American Society of Clinical Oncology (ASCO) annual meeting .
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Two phase 3 pediatric clinical trials of Merck's 15-valent pneumonia vaccine V114 reach dual primary endpoints
Time of Update: 2021-06-30
In the supplementary study, Merck said that V114 is used for supplemental vaccination programs for healthy children aged 7 months to 17 years who have not previously been vaccinated with pneumococcal vaccine, or have previously received part or all of the PCV treatment program.
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The development of new drugs for cardiovascular diseases is progressing slowly. How should pharmaceutical companies break through the bottleneck?
Time of Update: 2021-06-30
According to Li Haiyan, director of the Drug Clinical Trial Center of Peking University Third Hospital, compared with clinical trials in the field of oncology, there are fewer clinical trials in the field of early cardiovascular disease: Cardiovascular drug development challenges and opportunities coexist Considering the cost, difficulty, trial registration requirements, and the efficacy of existing drugs on the market, some pharmaceutical companies have given up on the types of drugs that once dominated innovation.
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Watson Bio-Recombinant Novel Coronavirus Vaccine (Chimpanzee Adenovirus Vector) Obtained Clinical Approval
Time of Update: 2021-06-30
On May 28th, Watson Bio announced that the company has recently received the "Drug Clinical Trial Approval Document" approved by the National Medical Products Administration for the recombinant new coronavirus vaccine (chimpanzee adenovirus vector) (hereinafter referred to as "the vaccine").
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Talking about: The influence of BCS classification on the solubility, permeability and dissolution of API
Time of Update: 2021-06-30
When it comes to the absorption rate and extent of the active pharmaceutical ingredient (Active Pharmaceutical Ingredient, hereinafter referred to as API) in oral solid common-release preparations, the BCS system mainly considers the following three key factors, namely: drug solubility (Solubility), intestinal tract Intestinal permeability and Dissolution .
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The first KRAS inhibitor received accelerated approval, non-pharmacological targets, counterattack multiple drugs on the road
Time of Update: 2021-06-30
On May 28, 2021, the FDA announced the accelerated approval of the KRAS inhibitor Lumakras (sotorasib, AMG510) [1] for the treatment of non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations.
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Nufoss Biosciences and Hodder Biosciences will jointly develop cell treatments for ophthalmic diseases based on human induced pluripotent stem cells
Time of Update: 2021-06-30
This cooperation combines Newforth's experience in global gene/cell therapy drug development, a deep understanding of eye diseases, and Hodder's advantages in the GMP production and quality system of human iPSC-derived clinical cell products, and it is expected to provide new A generation of treatment methods for eye diseases .
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Pfizer tofacitinib reaches its primary endpoint in Phase 3 clinical trial for COVID-19 inpatients
Time of Update: 2021-06-30
The results of the study provide new information indicating that adding tofacitinib to the standard of care, including glucocorticoids, can further reduce the risk of death or respiratory failure in patients .
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China's self-developed and innovative biopharmaceutical listing application was accepted by the FDA for the first time and entered the review stage
Time of Update: 2021-06-30
1 The new drug application (BLA) for the first-line treatment of non-squamous non-small cell lung cancer (NSCLC) with monoclonal antibody daboshu combined with pemetrexed and platinum, which marks the complete listing of innovative biological drugs independently developed by China The application was accepted by the US FDA for the first time and entered the formal review stage.
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Novavax new crown trimeric protein vaccine is comparable to mRNA vaccine, clover biology is on the way
Time of Update: 2021-06-30
On June 14, 2021, Novavax announced that the new crown vaccine NVX-CoV2373 Phase III clinical success, with an overall protection rate of 90.
Due to the stronger side effects of AS03 adjuvant, Clover used CpG1018 plus aluminum adjuvant in the third phase of clinical trials .
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What is tumor targeted therapy?
Time of Update: 2021-06-30
Tumor targeted therapy refers to a treatment method that targets drugs or biological products that inhibit the growth and development of tumors to the local area of tumor tissues so as to reduce the toxic and side effects on normal tissues and organs .
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AffaMed Therapeutics announces that AM006 for the treatment of Parkinson's disease has been approved for IIb clinical research in China
Time of Update: 2021-06-30
AffaMed Therapeutics, a clinical-stage innovative biomedical company dedicated to meeting the global needs for the treatment of ophthalmology, neurological and psychiatric diseases, today announced that the National Medical Products Administration (NMPA) has approved the global IIb clinical trial application (CTA) led by it.
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Merck's Keytruda 7th indication is approved in China for the first-line treatment of colorectal cancer
Time of Update: 2021-06-30
In this phase 3 clinical trial, pembrolizumab single-agent treatment of patients with MSI-H or dMMR unresectable or metastatic colorectal cancer can reduce the risk of disease progression or death by 40%, and the median progression-free survival It was 16.
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Avenue's new drug application for non-opioid painkiller tramadol was rejected again by FDA
Time of Update: 2021-06-30
According to the detailed information of the complete response letter (CRL) issued a few days ago, the US Food and Drug Administration (FDA) once again refused to approve Avenue Therapeutics intravenous injection, the non-opioid painkiller tramadol .
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BCMA target is strong, who can be proud of the arena?
Time of Update: 2021-06-30
At present, CAR-T cell therapy and ADC drugs targeting BCMA have been approved for marketing, and dual-antibody drugs are gaining momentum .
In the future, it is worth thinking about who can be proud of BCMA-targeted double antibodies, ADC and CAR-T .
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What do you think about the future of Alzheimer's disease treatment from Aduhelm to GV-971?
Time of Update: 2021-06-29
" Behind the huge surprises and controversies of the two AD treatment drugs that have been approved domestically and internationally, we should calmly explore the significance of their practical needs for patients: ● Judging from the mechanism of GV-971 and Aduhelm, when will human beings find a new weapon to truly fight Alzheimer's disease?
