"Pharmaceutical Rapid Reading Society" IL-6R antibody new crown phase III clinical failure 4 innovative drugs approved in China.

July 30, 2020 / Pharmaceutical Information List: Roche IL-6R Antibody New Crown Phase III Clinical Failure; Vantage Bio and Sanofi Reach Rotavirus Vaccine Licensing License Deal; AbbVie Oral CGRP Receptor Antagonist Reaches Phase 3 Clinical End; BMS Resysitses CAR-T Cell Therapy Listing Application for Treatment of Multiple Myeloma... Daily fresh medicine news, quick reading with you to pay attention to! Part 1 Policy Brief 2019 Drug Review Report was officially released on the 30th, the official website of the State Drug Administration released the 2019 Drug Review Report.
include the following aspects: the acceptance of drug registration applications, the approval of drug registration applications, the variety of key therapeutic areas, the progress of key work and the priority work arrangements for 2020.
(State Drug Administration) July 29 new confirmed local cases 102 cases July 29 0-24 hours, 31 provinces (autonomous regions, municipalities directly under the Central Government) and Xinjiang Production and Construction Corps reported 105 new confirmed cases Among them, 3 cases were imported from abroad (1 case in Guangdong, 1 case in Yunnan, 1 case in Shaanxi), 102 cases in China (96 cases in Xinjiang, 5 cases in Liaoning and 1 case in Beijing);
(National Health Care Commission) latest news: pharmacy supervision has changed 29, Ningxia Drug Administration issued "on the implementation of the "sunshine pharmacy" project construction pilot work notice" clearly put forward, in order to effectively promote the modernization of drug regulatory system and regulatory capacity, further standardize the retail pharmacy drug business behavior, plans to use 3 years in the region's drug retail supervision field to implement the "sunshine pharmacy" project.
(Ningxia Drug Administration) Part 2 production has been observed Roche obtained UCB in the study of anti-Tau antibody exclusive global license 29, UCB announced with Roche and its gene Tektronum reached an exclusive global licensing agreement for its research drug UCB0107 global development and commercialization in response to Alzheimer's disease.
UCB0107 is a recombinant humanized IgG4 monoclonal antibody that targets the center Tau protein antigen eliter and is expected to block/reduce the pathological transmission of Tau protein.
(Sina Pharmaceutical News) Vantage Bio and Sanofi reached a rota vaccine licensing transaction Vantage Bio wholly owned subsidiary Xiamen Vantai Bohai Biological authorized Sanofi to develop, produce and commercialize new rota vaccines, mainly for the prevention of childhood diarrhea caused by type A rota virus.
The transaction involves two parts: 1) a total of $68 million in advances and milestones, including $10 million in advances and $58 million in milestone payments, and 2) a licensing fee of 1 or 2 percent of net sales for product varieties sold after commercialization.
(Pharmaceutical Mission) Part 3 Drug News Roche IL-6R Antibody New Crown Phase III Clinical Failure Roche announced that its IL-6 receptacle antibody Actemra in a Phase III clinic called COVACTA failed to reach the trial grade 1 and primary secondary endpoint.
the trial recruited new coronary patients with severe pneumonia who needed hospitalization, comparing actemra with placebo's effect on patients' condition in the context of standard therapy, missing a level 7 gradient severity score.
also failed to change the critical secondary endpoint of the four-week mortality rate, but it seems to be able to shorten hospital stays.
(Using Chinese medicine source) AbbVie oral CGRP receptor antagonists reached phase 3 clinical endpoint AbbVie announced that it reached its primary endpoint in the Phase 3 clinical trial ADVANCE for the prevention of migraines, with all doses significantly reducing the average number of migraine days per month compared to placebos during 12 weeks of treatment.
(Drug Mingkangde) Mercerton Innovation Therapy was recognized by the FDA Breakthrough Therapy for the treatment of specific renal cell carcinoma patients Mercerton announced that the FDA has granted its oxygen-deficoxide-induced factor-2 alpha inhibitor MK-6482 breakthrough therapy for the treatment of von Hippel-Lindau disease-related renal cell carcinoma patients, who carry less than 3 cm size non-metastatic RCC tumors.
BMS has resubmitted its CAR-T cell therapy listing application for the treatment of multiple myeloma BMS and bluebird bio jointly announced that it has submitted to the FDA a license application for biological products of the jointly developed CAR-T therapy idcabtagene vicleucel.
this is a chimed antigen receptor T-cell immunotherapy that targets B-cell mature antigens for the treatment of adult patients with recurrent/incurable multiple myeloma.
Oshitinib-assisted treatment of early EGFR mutant lung cancer has been approved by the FDA Breakthrough Therapy, and Oxitinib (Osimertinib, Tagrisso) has been recognized in the United States as a breakthrough therapy (BTD) to assist in the treatment of early epidermis growth factor receptor mutations in non-small cell lung cancer patients after a complete excision of curative treatment.
the BTD was based on stunning results from the Clinical Phase 3 trial, which reduced the risk of recurrence or death by about 80 percent.
(Immediate Medicine) treatment of breast cancer Novarte PI3K inhibitors were approved by the European Union local time on the 29th, Novarro announced that the European Commission has approved Piqray (an oral small molecule alpha-specific PI3K inhibitor) and fluvys for use in post-menopingeal women and men with breast cancer.
these patients were positive for hormone receptors, human epiderm growth factor receptors-2 were negative, and the disease continued to progress after a single endocrine therapy, carrying THEK3CA mutation and showing local late stage or metastasis.
(Sina Pharmaceutical News) 4 innovative drugs approved for market in China according to the NMPA drug approval notice shows that 4 innovative drugs approved for the Chinese market, respectively, Goliath hepatitis C drug Ravidavi, pre-acoustic stroke drug Ida lavino rightol, Mercadon sugar-lowering drug Aigley net and Pfizer eczema drug Cleri boro.
according to the latest information on the CDE website, regenerative city submitted a clinical application for anti-HIV-1 chimed antigen receptor T-cell injection and was accepted on July 30.
It is understood that the therapy was developed by Professor Zhang Hui of Sun Yat-sen University, which can effectively induce the cells of HIV-1-infected CD4 T lymphocytes to dissolve the chimedic antigen receptogen T cells, with the aim of reconstructing reliable immuno-surveillance, eradicating reactivated HIV-1 infected cells, with the potential for functional cure of AIDS.
(CDE) Xinhua Pharmaceutical Phenylhela Postcards through generic drug consistency evaluation Xinhua Pharmaceuticals issued a notice that received the Approval of the State Drug Administration issued by the State Drug Administration of benzene hella tablets (25 mg) "Drug Supplement Application Approval Notice", the product through generic drug quality and efficacy consistency evaluation.
company became the second company in China to pass a generic consistency evaluation of benzene hela postcards (25 mg).
(Xinhua Pharmaceutical Announcement)