"Pharmaceutical Express" China's new crown vaccine UAE approved the listing of 218 drugs to determine the scrap standard

December 9, 2020 / Medical Information List: FDA releases detailed evaluation of Pfizer/BioNTech new crown vaccine; Blinger Ingehandabiga group ester control 0-18 years old children VTE was positively evaluated by CHMP; Amjin KRAS inhibitor was recognized by FDA breakthrough therapy; China's new coronary inactivated vaccine UAE approved for listing ... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief 218 applications for drug scrapping were approved on December 8, Ningxia Hui Autonomous Region Public Resources Trading Service Center announced, agreed to 100 enterprises on the drug scrapping bid (revoke the net) application, to cancel the above enterprise drugs winning bid (hanging net) qualification.
the scrapping involved 218 drugs, 61 of which were low-cost.
(Ningxia Hui Autonomous Region Public Resources Trading Service Center) Part 2 co-developed implantable stem cell therapy to treat type 1 diabetes on December 8th, No.
(Sina Pharmaceutical News) Johnson and Johnson and Xencor reached a CD28 dual anti-development cooperation on December 7, Xencor announced a cooperation agreement with Johnson and Johnson on the development of XmAb® dual-specific antibody targeting CD28.
deal is expected to be completed by the end of the year.
(Pharmaceutical Rubik's Cube) Aris Global announced a major partnership with Zeal Pharmaceuticals Today, Aris Global announced a major partnership with Zeal Pharmaceuticals, which has chosen Aris Global's LSMV as its first patient safety system to facilitate the safe and faster time to market of its products.
Pharmaceuticals and Apple BioMath launched a strategic partnership to initiate pharmacological modeling of tumor systems Today, Deki Pharmaceuticals announced a strategic partnership with Appleed BioMath, LLC to advance systematic pharmacology modeling of tumor immunity.
this collaboration aims to predict the starting and effective dose of the PD-L1/4-1BB dual-specific antibody ATG-101 for the first human use.
(Agency) Idea Di Pharmaceuticals $200 million to introduce 2 new cancer immunotherapy drugs on December 8, Widi Pharmaceuticals announced a partnership with SELLAS Life Sciences Group to obtain more than 200 million U.S. dollars for the exclusive development and commercialization rights of the latter 2 tumor immunotherapy innovative drugs for all adaptations in Greater China.
(Pharmaceutical Mission) and Yuan Bio received an exclusive investment of 100 million yuan from Tencent recently, and Yuan Bio announced the completion of a billion yuan C-plus financing, the current round of financing by Tencent's exclusive investment.
and meta-organisms focus on gene therapy and cell therapy CDMO industry, will accelerate the construction of recombinant viral drug CRO service center and gene drug production CDMO/CMO base with the help of capital.
company filed for a NASDAQ IPO with AbCellera, Inc. announced that it has filed for a NASDAQ IPO to raise $357 million.
its core technology, a high-flung microflow platform can be customized to the type of disease and application target, further structural optimization and source optimization in the screening of alternative antibodies to provide high-quality antibody candidates.
3M is expected to save $200 million to $250 million a year in pre-tax costs after announcing it would cut 2,900 jobs globally, according to Reuters, the Associated Press and other media outlets.
revenue data for the first three quarters of this year showed that revenue in its healthcare business sector grew 25.5 percent year-on-year.
(Seber Blue Device) Part 3 Drug News FDA released a detailed evaluation of the Pfizer/BioNTech new crown vaccine today, the FDA's official website announced an internal scientist's assessment of the EUA application materials for BNT162b2.
10, the FDA will convene a meeting of the Advisory Committee on Vaccines and Related Biologics to review BNT162b2, a candidate new crown vaccine jointly developed by Pfizer/BioNTech.
(Xinhua) -- The Lancet published detailed results of the AZ/Oxford New Crown Vaccine today, AstraZenecom announced that the results of a mid-term analysis of a Phase 3 clinical project conducted by Oxford University on the candidate new crown vaccine AZD1222 have been peer-reviewed and published in The Lancet.
the results showed that the vaccine was safe and effective in preventing COVID-19 from developing symptoms and could prevent serious illness and hospitalization.
(Pharmaceutical Mingkangde) Johnson amp; Johnson Amivantamab domestic start Phase III clinical December 8, Johnson and Johnson first launched EGFR/c-Met dual anti-Amivantamab Phase III clinical, combined with the third generation EGFR inhibitor Lazertinib first-line treatment of late-stage non-excisible NSCLC.
that the dual resistance is a breakthrough therapy U.S.-China dual-certified products, Johnson and Johnson has recently submitted to the FDA biological products licensing application.
(Insight Database) Roche released three of the latest clinical data on dual anti-drugs in research Roche on ASH 2020, showing positive results for many types of blood tumors: mosunetuzumab achieved 51.6% (32/32/1) in R/R FL patients 62) full remission rate; glofitamab achieved an objective remission rate of 53.6% (15/28) in invasive NHL patients; and cevostamab achieved an objective remission rate of 53% (18/34) in patients with multiple myeloma treated with severe treatment, and remission was observed in high-risk patients.
(Medical Rubik's Cube) Pfizer Haemophilia A Gene Therapy Update 1/2 Results December 7, Pfizer and Sangamo jointly announced on ASH 2020 severe haemophilia A patient gene therapy Giroocotogene fit The latest follow-up data from the 1/2 clinical study of elparvovec: All five patients in the high-dose 3x1013vg/kg queue who were treated with the gene therapy were followed for at least one year, and all patients maintained consistent levels of human coagulation factor VIII activity.
(Xinhua) -- Pfizer (Sina Pharmaceutical News) released CD3 dual anti-treatment multiple myeloma Phase I data on December 7, Pfizer announced its targeted B-cell mature antigen (BCMA)-CD3 dual-specific antibody PF-06863135 therapeutic recurrence/refractic multiple myeloma Phase I clinical study safety and effectiveness data.
data from 30 recurring/refractive MM patients showed that all doses of subcute injection PF-06863135 were safe and controllable, and no dose-limiting toxicity reaction was observed;
(Pharmaceutical Rubik's Cube) Bollinger Ingehandabica esters prevention and treatment of 0-18 years old children VTE by CHMP positive evaluation recently, Bollinger Ingham announced that the European Medicines Agency CHMP adopted the submitted for the treatment of children under 18 years of age venous thrombosis and prevention of VTE recurrence adaptation.
studies have shown that dabiga esters have good safety outcomes for children with VTE and risk factors for persistent thrombosis.
(Agency) Amgen KRAS inhibitors by the FDA breakthrough therapy recognized today, Amgen announced that the U.S. FDA has awarded it in the study of KRASG12C inhibitor sotorasib breakthrough therapy identified for the treatment of local late stage or metastasis carrying KRASG12C mutation of non-small cell lung cancer patients.
the same time, Amjin announced that Sotorasib had been included in the FDA's real-time oncology review pilot program, which is expected to further accelerate its review.
the first Phase 3 clinical trial of haemophilia B gene therapy reached its primary endpoint today, uniQure announced on ASH 2020 the latest data on key Phase 3 clinical trials in the study of gene therapy etranacogene dezaparvovec for haemophilia B.
results showed that after 26 weeks of treatment, the level of coagulation factor IX activity in patients increased from less than 2% of the baseline to 37.2%, reaching the first major endpoint of the study.
(Picminconde) Oncopeptides published new data from the Multiple Myeloma II. Phase ANCHOR Joint Study Oncopeptides AB recently released the latest positive data on the efficacy and safety of the ongoing Phase II ANCHOR Joint Study at ASH 2020: the total remission rate of melofinga symison combined darato monoantigen was 73%, and the total mitigation rate of joint boronzomi was 62%.
used jointly with Dalato monoantigen, the median non-progressed lifetime was 12.9 months.
(Biological Exploration) Repotrectinib was named the FDA's Breakthrough Therapy on December 8th, turning Point announced that its candidate drug for the treatment of ROS1-positive metastasis non-small cell lung cancer that has not been treated with ROS1 tyrosine kinase inhibitors has been awarded the FDA's Breakthrough Therapy title.
(Xinhua) -- China's new crown inactivated vaccine UAE has been approved for listing today, the UAE News Agency reported, the country's Ministry of Health and Prevention announced the national pharmaceutical group China Bio-Beijing Biological Products Research Institute developed a new coronavirus inactivated vaccine registered in the country.
data show that the vaccine is 86% effective against viral infections, the moderate antibody yang rate is 99%, can 100% prevent moderate and severe cases of new coronary pneumonia.
and studies have found no serious safety risks with vaccines.
(Sina Pharmaceutical News) Dong'e Pharmaceuticals announced the results of the ADC drug TAA013 Phase I research today, Dong'e Pharmaceuticals announced that its self-developed antibody association drug TAA013 Phase I clinical results were published on SABCS 2020 and presented in the form of electronic wall newspapers.
results showed good safe tolerance of TAA013, and preliminary efficacy was observed in HER2-positive breast cancer patients treated with excessive line anti-HER2 targeted drugs.
(Pharmaceutical Rubik's Cube) Lingteng Pharma completed the first patients in the first phase of the Global Phase III Clinical Phase III of Catoso Gastric Cancer Today, Lingteng Pharmaceuticals announced that Catumaxomab completed the first patient in Taiwan in the first phase of the Global Phase III Clinical Study of Gastric Cancer on October 6, and recently conducted clinical trials in Korea.
Phase III trial was designed to assess the safety and effectiveness of catoso double anti-abdominal perfusion in patients with peritina metastatic gastric cancer who were not suitable for systemic chemotherapy.
(Pharmaceutical Rubik's Cube) Coxing Bio23 Price Pneumonia Vaccine was approved for listing in China Today, Koxing Holding Biotechnology Co., Ltd. announced that its subsidiary Cochlear Bio developed a 23-price pneumococcal polysaccharide vaccine has been issued by NMPA on December 2 "Drug Registration Approval", will soon be listed.
(immediate drug news) Cozi bioCT053 all-human anti-BCMA CAR T cell injection into the breakthrough treatment varieties December 8, Koji Bio announced that its CT053 all-human anti-BCMA auto-CAR T cell injection through the CDE publicity period, into the breakthrough treatment drug varieties, the formulation of adaptation for recurring refractive multiple myeloma (R/R MM).
(American News Agency) Hengrui Pharmaceutical dry eye disease new drug NOV03 was approved clinical December 7, Hengrui Pharmaceutical announced that recently received the State Drug Administration approved the issuance of the "Drug Clinical Trial Approval Notice", approved SHR8058 (perfluorohexyl octane) drop eye drops to treat blepharma-plate gland dysfunction-related dry eye disease.
currently has no products with the same mechanism on the market.
(Pharmaceutical Rubik's Cube) Hengrui Pharmaceutical deoxynephrine ketic acid solution reported on December 7, CDE official website shows that Hengrui Pharmaceutical submitted 3 classes of generic epinephrine ketamine acid solution to market applications for cataract surgery or artificial crystal replacement surgery to maintain pupil size, prevent the pupil in surgery to shrink and relieve pain in the eyes after surgery.
(Insight Database) Biopolytics submitted a clinical application for Scuciu mono-biosynthic drugs on December 7, CDE announced that Bio-Octet submitted a clinical trial application for Scudciu mono-anti-injection by registered classification 3.3, and was accepted.
Skuchiyu monoantigen is a biologic agent targeting IL-17A, and the original research product secukinumab has been approved in China for moderate to severe plaque-type psoriasis and strong spina bouts.
(Medical Mission)