Research and development daily Sanofi Pompeia Therapy is eligible for FDA priority review

2020.11.19 Research and Development NEWS: Engele Net Milestone Phase 3 Clinical: Treatment of Type 2 Diabetes Significantly Reduces Cardiovascular Event Risk; Gilead's new shell function inhibitor Lensapavir Phase 2/3 Clinical End; Pfizer/BioNTech announces that it will submit a New Crown Vaccine EUA Phase 3 Clinical End; Kangzhe Pharmaceuticals " Degree sta tablets" declare clinical... We focus on the latest developments in pharmaceutical research and development, to provide research and development personnel with timely and accurate information reference.
(click on the title, read the original) Ingley Net Milestone Phase 3 Clinical: Treatment of Type 2 Diabetes Significantly Reduces Cardiovascular Event Risk November 18, Grigg Ingham and Lilly Diabetes Alliance announce a new post-mortem analysis of the SGLT2 inhibitor Jardiance (empagliflozin, Ingley Net) Milestone EMPA-REG OUTCOME trial.
study showed that Jardiance reduced the overall risk of cardiovascular events (first-time recurrence) compared to placebos.
Gilead's new shell function inhibitor lenspavir Phase 2/3 clinical end! On November 18, Gilead announced the top-line results of the Phase 2/3 clinical CAPELLA trial, which evaluated the efficacy and safety of the research-based, long-acting HIV-1 shell inhibitor lensavivir, which has been treated multiple times for HIV Type 1 (HIV-1) multiple drug-resistant infections.
Pfizer/BioNTech announced that it will submit a new crown vaccine EUA application for Phase 3 clinical end 18, Pfizer and BioNTech announced that after conducting a phase 3 clinical study of the final efficacy analysis showed that the candidate new crown vaccine BNT162b2 reached all the major therapeutic endpoints of the study, the FDA required emergency use authorization safety milestone has been achieved, they plan to submit an EUA application to the FDA within days.
and VBI Vaccines said the interim data for the CHB immunotherapy 1b/2a trial were positive today, and VBI Vaccines and Tensenberg Pharmaceuticals announced that the ongoing BRII-179 (VBI-2601) 1b/2a study showed positive interim results.
VBI-2601 is a new candidate for recombinant protein immunotherapy for the treatment of chronic hepatitis B virus infection.
ASC40 (TVB-2640) China PHASE NASH trial completed patient group today, Goliath Pharmaceuticals, a wholly owned subsidiary of Ganlai Pharmaceuticals and Sagimet Biosciences, jointly announced that ASC40 (TVB-2640) China PHASE NASH trial has completed the patient group.
30 patients in the trial group as part of the International Multi-Center Phase II clinical trial.
Drug Approval: Sanofi Pompeid Disease Therapy's FDA Priority Review Eligibility is expected to become the new standard therapy, Sanofi announced, the U.S. FDA has accepted the company's biological product licensing application (BLA) for avalglucosidase alfa, used as a long-term enzyme replacement therapy to treat Pompeid patients.
fda also granted priority review of the application and is expected to respond by May 8 next year.
Baiji Shenzhou Ruifumei was approved for the third indication treatment recurrence / resuscable inert lymphoma today, according to the NMPA drug approval issued notice shows that Baiji Shenzhou's Lanadamine (Rui Fumei) obtained a new drug approval number.
the drug is intended to be used in the same way as lyxidan, to treat patients with recurring or refragsive inert lymphoma (filamentatic or marginal lymphoma).
the first home-made APK inhibitor! Beda Pharmaceuticals" "Nsatini" was approved for listing on November 19, Beda Pharmaceuticals submitted the ALK inhibitor Nsatini (commodity name: Bemena) listing application was approved by the State Drug Administration.
the conditions declared for this declaration are: new treatments for patients with localized late stage or metastasis non-small cell lung cancer who have progressed after treatment with clostrini or who are resistant to alkydinist.
Shandong Kongfu Pharmaceutical Anli shengtan tablet imitation 4 types of listing applications were accepted on November 19, CDE official website shows that Shandong Kongfu Pharmaceuticals' Anli shengtan tablets with imitation 4 categories of submitted listing applications were accepted.
, Wuhan People's Fu Pharmaceuticals, Jiangsu Jiayi Pharmaceuticals, Jiangsu Deyuan Pharmaceuticals to copy 4 categories of applications submitted for listing, in the review and approval.
Qilu Pharmaceuticals "Hydrochloric acid methicillin oral dissolved membrane" declared on November 18, Qilu Pharmaceuticals submitted a class 2.2 new drug hydrochloric acid methicillin oral dissolved membrane listing application was accepted by CDE for the treatment of moderate to severe Alzheimer's-type dementia.
Kangzhe Pharmaceuticals "Tedo Sta tablets" declared clinical recently, Kangzhe Pharmaceuticals submitted a clinical application for new drugs of the new drugs was accepted by CDE.
is an oral hypoxic induction factor proline hydroxyase inhibitor (HIF-PHI) intended to treat anemia in patients with chronic kidney disease (CKD).
Rongchang bioc-met targeted ADC domestic first approved clinical 18, CDE official website shows that Rongchang biological class 1 new drug "injection RC108" was approved clinically, for c-Met positive late-stage malignant solid tumor.
most of the c-MET targeted drugs currently under study in China are small molecule drugs, and only 4 antibody drugs are currently in clinical stage.
100Ote was approved by NMPA to issue BAT1006 injection clinical trial notice today, BaeOte announced that it has received the Approval of the State Drug Administration issued in the study of the drug BAT1006 injection "clinical trial notice."
Yangzijiang Pharmaceuticals", "Entikave oral solution" was first approved 19, NMPA's latest batch shows that Yangzijiang Pharmaceuticals 3 classes of generic drug "Entikave oral solution" was approved, successfully obtained the first imitation of this variety in China.
new discovery in the latest research! Melatonin may be expected to help treat new coronary pneumonia In a recent study published in the international journal PLoS Biology, scientists from institutions such as the Cleveland Clinic found that melatonin may be a new treatment for COVID-19.
, Inc., published data from phase 1/2 clinical trials of the CoronaVac vaccine that triggers a rapid immune response, November 17, local time.
from the article, CoronaVac triggered a rapid immune response in the subjects, providing adequate protection to help them protect against the new coronavirus (SARS-CoV-2).