"Pharmaceutical Express" K drug combination therapy by the FDA priority review of Bedane Shatini...

December 18, 2020 / Medical Information At a Glance: K-drug combination therapy was approved by the FDA for priority review; FDA approved the first lupus nephritis therapy; three new Class 1 drugs are to be included in the breakthrough treatment variety; Beda Pharmaceuticals Ensarini is priced out; and it is reported that the company is going to lay off workers again... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief The Health Insurance Bureau promotes the collection and use of national organization crown veins On December 17, the National Health Insurance Administration issued the Opinions of the National Organization Coronary Bracket on centralized belt procurement and use of supporting measures.
pointed out that the health insurance departments in the integrated areas should establish an advance payment mechanism on the basis of the budget management of the total amount of the health insurance fund.
the medical institution signs a purchase agreement with the selected enterprise, the medical insurance fund shall be paid to the medical institution in advance at not less than 30% of the amount agreed upon annually.
at the same time, it is emphasized that the selected products of the crown stent collection are listed on the centralized procurement platform of the provincial medicines according to the selected price, the medical institutions are purchased according to the selected price, and the patients are used according to the selected price.
(National Health Insurance Bureau) Shandong to carry out five types of consumables with volume procurement December 16, Shandong Province Public Resources Trading Center released "Shandong Province high-value medical supplies centralized belt procurement documents (draft for comments)" shows that the coronary intervention class rapid exchange expansion balloons, the initial replacement of artificial hip joints, absorbable hard brain (spine) membrane patch, disposable sleeve puncture, cardiac arrester (double cavity) five categories of consumption.
documents require that the next year's procurement demand reported by medical institutions be summarized, and the agreed purchase quantity of the selected enterprises in this group shall be determined according to 70% of the corresponding procurement demand of the corresponding enterprises in each group.
(Shandong Province Public Resources Trading Center) Part 2 after observation of the news that yan Zhi will be laid off again recently, there are media reports of new layoffs plan.
is known to be planning to lay off workers from the pain sector.
that 20 per cent of anti-infection product line representatives in an area will be cut next week.
previously, there had been internal adjustments in the CV plus pain area.
the current adjustment and bidding in some regions has only just begun.
announced that it is paying $210 million for Cadent and a possible $560 million milestone in the future, just days after Novarma's $770 million acquisition of Cadent.
will receive all of Cadent's outstanding shares, and the acquisition is expected to close in the first quarter of next year.
acquisition, Novart will have Cadent's complete portfolio of neuroscience products, including the NMDAr project.
(Sina Pharmaceutical News) Neurogene completed a $115 million round B financing recently, Neurogene announced the completion of a $115 million B round of financing, this round of financing led by EcoR1 Capital.
Neurogene is working on innovative gene therapies for rare neurological diseases, using adeno-related viruses as vectors to deliver normal genes to patients with genetic dysfunction.
Capital's acquisition of innovative surgical robots announced on December 16th that it had completed its controlling acquisition of Endoways, a fully consumables vascular interventional surgical robot company.
this acquisition, Jess Capital will continue to promote the development and listing of Endoways' core products, particularly clinical research and registration in China, in partnership with strategic partner Deno Healthcare.
(Creative Exchange) Beda Pharmaceuticals Ensatini pricing today, Beda Pharmaceuticals in response to investors' questions, said that the terminal price of Nsatini capsule hydrochloric acid is 1358 yuan / bottle (size: 25mg x 7 capsules / bottle) and 7644 yuan / bottle (size: 100mg x 14 capsules / bottle).
(Insight Database) Part 3 Pharmacy Keytruda combination therapy has been approved by the FDA for priority review today, Mercadon announced that the FDA has accepted a request for a supplemental biologics license for the heavy PD-1 inhibitor Keytruda for use in combination with chemotherapy, a first-line treatment for local late-stage non-removable or metastatic esophageal cancer and gastroesophageal cancer patients.
the FDA at the same time grants priority review eligibility for this application.
(Xinhua) -- The FDA has approved the first lupus nephritis treatment today, GlaxoSmithKline announced that the U.S. FDA has approved Benlysta's extended allergy for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.
this is the first FDA-approved treatment for LN.
(Pharmaceutical Mingkangde) Bringer Ingehanidanib was approved in China today, NMPA issued a notice, Bringer Ingham TKI inhibitor Nintedanib, Ofev submitted a new adaptation listing application in China was approved.
new adaptation approved this time is: for the treatment of aggressive fibrosis interstitiotic lung disease.
(P.D.) FDA advisory committee voted in support of Moderna's new crown vaccine today, at the FDA's VRBPAC meeting, experts discussed the EUA application for the new crown vaccine mRNA-1273 developed by Moderna.
, experts voted 20 to 1 abstention in favour of a new crown vaccine developed by Moderna that benefits more than risk when used in individuals 18 years of age and older, based on available scientific evidence.
(Pharmaceutical Mingkang) Amgen Biosynthetic Drug RIABNI was approved by the FDA on December 17, Amgen announced that the U.S. FDA has approved the U.S. listing of the Biosynthetic Drug RIABNI™ (rituximab-arrx) for the treatment of adult non-Hodgkin's lymphoma, chronic lymphocytic leukemia, sarcophagus polyvascular disease and microscope.
RIABNI will go on sale in January 2021.
(Sina Pharmaceutical News) EU CHMP recommends approval of Sanofi Pliavix combined aspirin to treat certain types of stroke Recently, Sanofi announced that the European Medicines Agency CHMP has issued a positive review recommending approval of Plavix (Polive) for a new adaptation: for the treatment of high-risk transient ischemic attack or mild ischemic stroke in adult patients.
this new adaptation includes combining Plavix with aspirin within 24 hours of onset and continuing for 21 days, followed by long-term single antiplatet treatment.
(Bio Valley) K drug combined with LENVIMA treatment of advanced endometrial cancer III. Phase III clinical reached a double major endpoint December 16, Mercadon and Japan's Akishi jointly announced their cooperation in Phase III clinical trial KEYNOTE-775/Study309 in the past at least one platinum drug treatment of patients with advanced endometrial cancer reached the total survival and non-progressive survival of the dual main endpoint, and objective mitigation rate of secondary endpoint.
(Sina Pharmaceutical News) Gilead Tecartus treatment package lymphoma was approved by The European conditional, Gilead subsidiary Kite Pharmaceuticals announced that the European Commission has granted Tecartus (formerly KTE-X19) conditional marketing license.
Tecartus is an autobiographic anti-CD19, chisellular antigen-infused T-cell therapy suitable for adult patients with recurring or refractic heterocellular lymphoma treated two or more times by the system.
(Sina Pharmaceutical News) three new class 1 drugs to be included in the breakthrough treatment varieties today, CDE latest publicity, three new drugs to be included in the breakthrough treatment varieties, namely: Blueprint Pharmaceuticals / Keystone Pharmaceuticals RET inhibitor BLU-667 capsules, proposed to develop for THE mutation-positive late-stage or metastasis MTC patients systemic treatment; Kinase inhibitor Theo Ronnie capsule, intended to develop a single drug treatment after 2-line system chemotherapy treatment of disease progression or recurrence of SCLC;
(Pharmaceutical Mission) Qilu Pharmaceuticals Pypsylli was approved for listing today, NMPA issued approval, Qilu Pharmaceutical 4 classes of generic pharmaceutical Pypsylli capsules were approved for the first time in the country.
its adaptive disorders are: first-line combined aromatase inhibitors for the treatment of post-menotinal women, hormone-positive, human skin growth factor inhibitor 2 negative local late stage or metastasis breast cancer.
(Insight Database) Yangzijiang Pharmaceutical iodized kesha alcohol injection two supplementary applications were approved today, NMPA official website shows that Yangzijiang Pharmaceutical Group's iodized kesal injection two supplementary applications were approved. sales of end-of-life iodized kesha alcohol injections in China's public medical institutions have grown rapidly in recent years, breaking the 3 billion yuan mark in 2019 and falling 4.18 percent year-on-year in the first half of this year, according to
meters of intranet data.
(Minenet) Chinese-led medicine Dozagliatin completed phase 3 registration studies Today, Chinese-led medicine announced the core results of the 28-week safety assessment phase of the second phase 3 registered clinical study of dozagliatin (dorzagliatin).
the results, Dozagliatin showed good safety and tolerance, with a lower risk of hypoglycemia (blood sugar below .lt;3 mmol/L) during 52 weeks of treatment.
, the patient's insulin resistance index continued to decrease.
(Pharmaceutical Mission) Deji Pharmaceutical SVd combination therapy rrMM Phase 3 clinical trial was approved by NMPA today, Deqi Pharmaceuticals announced that NMPA has approved oral selective nuclear output inhibitor ATG-010 (selinexor) and boronicazome, dexamethason combination treatment of chinese patients with recurring refractic multiple myeloma clinical trial application.
ATG-010 is the first and only oral selective nuclear output inhibitor of its kind.
(Agency) Tagire Bio's third generation ALK inhibitor was approved for clinical practice on December 17, according to CDE publicity, Tager bio with chemical Class 1 TGRX-326 tablets obtained two clinical trials implied permission to develop adaptations as: ALK-positive or/or ROS1-positive advanced non-small cell lung cancer.
, TGRX-326 is the third generation of ALK high-efficiency inhibitors that target the EML4-ALK fusion gene, according to publicly available data.
(Pharmaceutical Mission) Fuhong Hanlitoxi single anti-biosynthic drug new adaptive drug listing application was accepted on December 17, Fuhong Hanxuan announced that NMPA officially accepted the Lytoxi single anti-biosychic drug HLX01 for the new adaptive rheumatoid arthritis listing application.
(Pharmaceutical Mission) State Pharmaceutical Group liquor acid butophine injection application was accepted on December 16, CDE official website shows that the national pharmaceutical group Guorui pharmaceutical company's liquor acid bhutolphine injection imitation 3 types of listing application was accepted.
meters of intranet data show that in the past two years in China's public medical institutions terminal Bhutto morphine injection growth rate of more than 30%, sales of more than 1.5 billion yuan;
(Miternet) Nature: POLRMT variant inhibitors are effective against tumors and do not harm healthy cells In a new study, researchers at karolinska College in Sweden have developed a new type of mitochondrial DNA inhibitor to replace mitochondrial inhibitors that were previously "two-and-a-half years old."
inhibitors prevent the proliferation of cancer cells and reduce tumor growth in mice, but do not have a significant effect on healthy cells.
(Medical Rubik's Cube)