Fda releases mRNA-1273 data Rongchang Bio...

December 16, 2020 / Medical Information List: FDA releases detailed data on Moderna's new crown vaccine; Takeda's innovative glucoticoid formula is eligible for priority review; Rongchang BioADC New Drug Launch Phase 3 Clinical; and BioFFR Inhibitors Approved Clinically ... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief Official issue to encourage prescription outflow Recently, the National Health Care Commission, the National Health Insurance Administration, the State Administration of Traditional Chinese Medicine issued a notice on "in-depth promotion of the "Internet plus medical health" "five one" service action."
"Notice" emphasizes that: the insured in the co-ordination area of the "Internet plus" medical services fixed-point medical institutions re-diagnosis and prescription of the medical institutions occurred in consultation fees and drug fees, can be paid in accordance with the provisions of the co-ordination area medical insurance;
(Health And Health Commission and other three departments) the national epidemic prevention and control of medical devices inspection began, the State Drug Administration held a meeting to strengthen the quality control of medical devices for epidemic prevention and control video, will further strengthen the new coronavirus detection reagents, medical protective clothing, medical masks, infrared thermometers, ventilators and other medical device quality supervision work.
(State Drug Administration) 14 large varieties began to take the procurement on the evening of December 14, Jiangsu Provincial Health Insurance Bureau issued the first round of drug centralized belt procurement announcement.
it is learned that this drug centralized band procurement has never been through the quality and efficacy of consistent evaluation of the varieties of screening to determine 14 varieties such as niacinamide injections for this band procurement varieties, of which 8 varieties are injections.
on December 15th Lilly and Prevail announced a deal to buy Prevail for $1.04 billion.
Prevail is committed to developing gene therapies based on AAV9 vectors for patients with neurodegenerative diseases.
Lilly will establish a gene therapy development program to broaden the treatment model for inherited neurodegenerative diseases.
(Pharmaceuticals) Lilly released its 2020 earnings forecast on December 15th, and Lilly released its 2021 financial results guidance, revising some of its 2020 financial results guidance and reviewing potential key events for the coming year.
expected full-year revenue of between $24.2 billion and $24.7 billion, and the market forecast of $23.98 billion, according to the company's 2020 financial results forecast.
2021 earnings are expected to be between $26.5 billion and $28 billion, including about $1 billion to $2 billion from COVID-19-related therapies, according to its 2021 financial results guidance.
(Xinhua) -- Gilead Dan O'Day abandoned a majority of its share of the Filgotinib partnership on December 15th, and Gilead and Galapagos announced that the two companies had agreed to modify existing commercialization and development arrangements for Jyseleca.
through a phased transition, the sale license for filgotinib is transferred to Galapagos, which is expected to be responsible for supporting most of Filgotinib's commercial activities in Europe by the end of 2021, provided that from 2024 it pays Gilead a tiered royalty of 8 to 15 per cent of its net sales in Europe.
Announcing the completion of a $100 million Round B financing, Locana announced the completion of a $100 million Round B financing led by Vida Ventures.
Locana is committed to the development of innovative gene therapies to cure a variety of diseases, including neuromuscular diseases, neurodegenerative diseases, and retinal diseases, by modifying disease-related dysfunctional RNA.
plans to close or spin off up to 15 manufacturing plants as part of the restructuring plan and possibly cut up to 9,000 jobs, or 20 percent of its 45,000 employees worldwide, according to foreign media sources such as Fierce Pharma.
said the job cuts would take place in stages over the next few years and had promised to find potential buyers for the facilities to preserve as many jobs as possible.
(Saibai Blue) Xinxusheng Technology announced the authorization of Yan Jian conditional use of tau protein PET tracer today, Xinxusheng Technology announced that it has authorized Yanjian in the global non-exclusive range of the use of the company's tau protein PET tracer 18F-APN-1607, in order to further study neurodegenerative diseases.
have been working together to develop a new PET tracer to identify the location and number of mutant tau proteins that accumulate in the brain.
280 million yuan B round of financing on December 15th, the company officially announced the completion of the 280 million yuan B round of financing.
, which focuses on the development of new treatments for major diseases such as influenza, avian influenza, idiopathic pulmonary fibrosis and NASH, has developed a new generation of RNA polymerase inhibitor ZSP1273 tablets in collaboration with the Zhong Nanshan academician team, which is a new class 1 drug that has entered phase 3 clinical phase.
(Pharmaceutical Mission) Lulu Pharmaceuticals will set up a joint venture to develop ADC and ready-to-use CAR-T therapy nearly two days, the company supported by Gao Lu Capital announced that it will jointly set up two joint ventures to develop ADC and ready-to-use iso-CAR-T therapy in Greater China and other regions.
December 9th, Lulu Pharmaceuticals just announced its official launch.
(Medical Mission) GEM City Committee to consider the first application of Shuyu civilians according to the Shenzhen Stock Exchange GEM listing committee previously disclosed that on December 15, gem on the GEM Municipal Committee on the initial application of Shuyu civilians for consideration.
, which has twice hit the IPO, filed for listing again in July.
(Pharmacy Manager)Yuan Gene completed 1 billion yuan financing recently,Yuan Gene announced the completion of nearly 1 billion yuan B round of financing.
this is by far the highest amount of corporate financing in the field of early screening of cancer in China.
this round of financing is mainly used to expand the research and development pipeline of its tumor early screening products, and will focus on promoting the registration and commercialization of each product, as well as the expansion of pan-cancer early screening products forward-looking verification.
(Medical Valley) Part 3 Drug News FDA released detailed data on Moderna's new crown vaccine today, the FDA announced on its official website the evaluation of the EUA application materials for mRNA-1273 by internal scientists, as well as the latest data provided by Moderna.
mRNA-1273 may also have good results in preventing asymptomatic infections, which have a significant impact on controlling the spread of the new coronavirus.
(Pharmaceutical Mingkangde) Takeda innovative glucoticoid formula was prioritized for review today, Takeda announced that the FDA has accepted its application for a new drug submitted by TAK-721, an oral remix agent in Budine, for the treatment of eosinophilic esophagealitis.
fda also grants this NDA priority review eligibility.
if approved, TAK-721 would be the first FDA-approved drug to treat EoE, a chronic inflammatory disease.
(Pharmaceuticals) FDA approved innovative topical therapy for facial or scalp AK today, Athenex and Almirall jointly announced that the FDA has approved the listing of Klisyri (tirbanibulin) for topical treatment of photochloric terrification of the face or scalp.
Klisyri is a micro-tube inhibitor that promotes apoptosis in the growth of cells by inhibiting micro-tube polymerization.
(Drug Mingkangde) regenerative blood tumor drug odronextamab multiple trials were called off by the FDA, the FDA told regeneratives to suspend its experimental blood tumor drug odronextamab (REGN1979) of a number of clinical trials.
THE FDA requires regenerative cells to further reduce the occurrence of stage 3 cytokine release syndrome.
trials affected by the suspension include the B-NHL's Phase 1 single-drug trial, the midterm examination of chronic lymphoblastic leukemia, and the single-drug treatment test for several B-NHL subsypes.
(Sina Pharmaceutical News) AstraZeneta/First Third ADC Drug Enhertu obtained conditional sales license in the European Union December 14, Astrascon/First Third Co., Ltd.'s trastuzumab deruxtecan obtained a conditional sales license from the European Commission for Human Medicines for non-removable or metastasis 2HER2 positive breast cancer patients who have received two or more anti-HER2 drug treatments.
(CPhI Pharmaceuticals Online) ViiV Healthcare released data from three studies on Dovato therapy, and ViiV Healthcare, an HIV drug research and development company owned by GSK, Pfizer and Yannoyi, presented 96 weeks of DATA from the TANGO study and three-year studies from two Phase III studies at the 2020 Glasgow HIV Drug Therapy Conference, confirming that Dovato therapy has no less long-term viral inhibition effects in adult patients with HIV-1 in the first treatment.
(US News Agency) Rongchang BioADC new drug launched phase 3 clinical recently, Rongchang Bio-autonomous research and development of injection recombinant humanized anti-HER2 monoanti-MMAE coupled agent (injection with wadixito monoanti, disitamab vedotin) has been A randomized, open, parallel control, multi-center Phase 3 clinical trial was initiated in China to assess the effectiveness and safety of treatment in patients with HER2 over-expression of localized advanced or metastatic stomach cancer (including gastroesophageal combined cancer) who had received at least 2 systematic chemotherapy sessions after recurrence/metastasis.
(Pharmaceutical Mission) EOC202 overseas trial significantly improved the total survival of patients with advanced breast cancer recently, Etenjingang Pharmaceuticals in the research product EOC202 (eftilagimod alpha) overseas partner Immutep officially announced its clinical IIb phase trial results in Europe, the overall patient population OS improvement trend is clear, in patients with low monocyte count, the median OS extended by 9.4 months, compared with the control group increased by 74%.
(Pharmaceutical Rubik's Cube) and renowned bioFFR inhibitors were approved for clinical trials on December 14, FGFR-targeted new drug ABSK091 (AZD4547) from Heyu Bio obtained NMPA-approved clinical trials in category 1 of chemicals, and was approved for clinical adaptations such as: advanced solid tumors and localized advanced or metastatic urethra cancer with FGFR2/3 gene mutations.
(Pharmaceutical Mission) Colum 1 new drug clinical application was accepted by CDE contractor on December 14, Columbotai, a subsidiary of Colum pharmaceutical holding company, with new drug Class 1 submitted SKB337 injection clinical application was accepted by CDE contractor.
drug is an ADC drug targeted at TRAP-2, and there is currently no drug on the market for the same target worldwide.
(Minenet) Yuriko Bio announced its preclinical results for the prevention of new coronal infections with human-based antibody nasal sprays on December 14, yurico Bio announced the results of a preclinical study of a mouse model of in-patient antibody™ nasal sprays being developed by the company to prevent infection with the new coronavirus SARS-CoV-2.
, the spray provides at least 10 hours of protection in mice exposed to SARS-CoV-2 fake virus infection.
(Pharmaceutical Mission) Sanno Bio Iteba peptide injection was approved for production and treated as a review day ago, Chengdu Sanno Bio to mimic the 4 categories of declared ideba peptide injection was approved for production and evaluation, as the first in the country.
is a plateboard glycogen II.b/III.a subject antagonist, clinically used to treat acute coronary artery syndrome.
intranet data show that in 2019 China's public medical institutions terminal growth rate of more than 200%.
(Minenet) Ted Pharmaceuticals Benzene Shun Aquku ammonium injection into the administrative approval stage, Beijing Ted Pharmaceuticals to imitate the 4 categories of reported benzene Shun Aquku ammonium injection into the administrative approval stage.
the drug is a skeletal muscle relaxant that can be used as an auxiliary drug for whole hemp or as a sedative in the ICU.
2019, sales of benzene-shun-aqugu ammonium injections in China's public medical institutions exceeded 2.5 billion yuan, up 9.66 percent year-on-year, according to the company's internal network data.
(Minet) NEJM: Redsyvir combination therapy is superior to single-drug therapy Recently, NEJM published the results of the double-blind, randomized, placebo-controlled trial ACTT-2 in combination with the antiviral drug Redsyvirus and the anti-inflammatory drug Baricitinib to treat new coronavirus diseases.
data show that this combination therapy can shorten the recovery time of COVID-19 hospitalized patients.
(Medical New Perspective) Nature: The psychedelic drug Iberg alkaline similar TBG is expected to treat addiction and depression without side effects Recently, a new study published online by Nature from the University of California, Davis, shows that researchers have developed a non-hallucinogenic version of the psychedelic drug ibogaine and named it TBG, which has the potential to treat addiction, depression and other mental illnesses.
(Bio Valley)