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Astellas geritinib fumarate tablets reach the primary endpoint of overall survival
Time of Update: 2021-04-24
Earlier this year, the China National Medical Products Administration (NMPA) conditionally approved geritinib for the treatment of FMS-like tyrosine kinase 3 (FLT3) mutations detected by fully validated detection methods Adult patients with relapsed or refractory acute myeloid leukemia (AML).
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Biogen's subcutaneous injection of natalizumab is approved in the EU for the treatment of multiple sclerosis
Time of Update: 2021-04-24
The new route of administration of the drug formulation provides comparable efficacy and safety to TYSABRI intravenous (IV) preparations, which are based on long-term treatment data, established clinical benefits and good safety.
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Idiopathic narcolepsy drug Xywav oral solution receives priority review by the U.S. FDA
Time of Update: 2021-04-24
In July 2020, Xywav was approved by the US FDA for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy (narcolepsy) aged 7 years and older.
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"Going to sea" failed!
Time of Update: 2021-04-24
On the evening of April 9th, Kanghong Pharmaceutical issued an announcement stating that the global multi-center clinical trial of Conbercept ophthalmic injection was stopped, which means that its core product, Conbercept, which was highly anticipated by the market, failed to “go out to sea”.
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Norway: AstraZeneca vaccine can cause extremely high levels of antibodies, leading to severe side effects from blood clots
Time of Update: 2021-04-24
The researcher studied 5 Norwegian patients aged 32 to 54 who had abnormal thrombosis within 10 days after vaccination with AstraZeneca.
Madsen said the study will influence the decision of the Norwegian Institute of Public Health (FHI) whether to re-vaccinate AstraZeneca.
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The financial director of the pharmaceutical company was taken away
Time of Update: 2021-04-24
On April 7, according to Yuyao Public Security News, Yuyao Public Security Bureau cracked a case of falsely issuing special value-added tax invoices and arrested a group of "false gangs" such as Liu XX, Liu XX, Xia XX and his sons.
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Dongyang Sunshine GLP-1/FGF21 dual agonist HEC88473 injection was approved for clinical use
Time of Update: 2021-04-24
HEC88473 is the first GLP-1/FGF21 dual agonist approved for clinical use in China.
GLP-1/FGF21 dual agonist is expected to produce synergistic effects on blood sugar and weight loss.
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CSPC JMT601 obtains clinical trial approval in the U.S.
Time of Update: 2021-04-24
. According to the announcement, JMT601 (CPO107) is the world’s first bispecific SIRPα fusion protein with a synergistic targeted binding effect that has entered the clinical stage.
The clinical data of these studies will lead the further development and approval of JMT601 (CPO107) for the treatment of non-Hodgkin's lymphoma and other hematological malignancies.
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Tianjing Bio and ABL Bio announce the completion of the first patient administration of TJ-L14B Phase 1 in the United States
Time of Update: 2021-04-24
On April 6, Tianjing Biotechnology and ABL Bio of South Korea jointly announced that the first US phase clinical study of the bispecific antibody TJ-L14B/ABL503 jointly developed by the two parties has completed the first patient administration.
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Bayer's Copanlisib lyophilized preparation for injection is planned to be included in the priority review program
Time of Update: 2021-04-24
In addition, Copanlisib is also carrying out a phase III study of CHRONOS-4 (domestic registration number: CTR20160362) combined with standard immunochemotherapy for the treatment of recurrent iNHL.
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Quotations from 265 pharmaceutical companies with 57 large varieties
Time of Update: 2021-04-24
265 pharmaceutical companies, competition is comingAccording to the "Notice on Carrying out Online Bargaining for the Sixth Batch of Guangxi Pharmaceutical Group Procurement (Second Batch) Varieties" issued by the Guangxi Pharmaceutical Group Procurement Service Platform, the Joint Procurement Office has determined the varieties and participating companies of this batch, which is scheduled for 2021 Online price negotiation will be conducted on April 7 (Wednesday).
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Pharmaceutical company executives quit the season!
Time of Update: 2021-04-24
LI MAO applied to resign from the position of director, senior vice president and chief medical officer of the third board of directors, senior vice president and chief medical officer of the company due to personal reasons.
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Takeda's 100 microgram dose of Natpara will be withdrawn for 1 year
Time of Update: 2021-04-24
CompilationFan DongdongTakeda announced in an open letter to the Hypoparathyroidism Association and the broader hypoparathyroidism patients and the medical community that 100 micrograms of Natpara may be interrupted as early as this week due to shortage of supply.
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FDA accepts AbbVie Atogepant new drug application for preventing migraine in adults
Time of Update: 2021-04-24
CompileriverOn March 30, AbbVie announced that the FDA has accepted Atogepant's New Drug Application (NDA), a research oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the prevention of meeting the criteria for paroxysmal migraine Of adult migraines.
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Pfizer announces data on Ibrance's first-line treatment of HR+/HER2-metastatic breast cancer
Time of Update: 2021-04-24
-Pfizer recently announced that real-world evidence (RWE) published in a peer-reviewed journal proves that in female patients with HR+/HER2-metastatic breast cancer (mBC), compared with letrozole, targeting The anticancer drug Ibrance (common name: palbociclib, piperacillil) combined with first-line treatment with letrozole improved real-world progression-free survival (rwPFS) and overall survival (OS).
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Sansheng Guojian and Immune Onco cooperate to carry out the clinical study of Septopin combined with IMM01
Time of Update: 2021-04-24
On April 7, Sunshine Guojian issued an announcement stating that it has recently signed a "Combination Drug Development Cooperation Agreement" with ImmuneOnco to jointly promote the anti-HER2 monoclonal antibody ceptin (initumab) and anti-CD47 fusion protein The clinical development and commercialization of IMM01 (hereinafter referred to as "IMM01") combination therapy in China.
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Talking about: Application of QbD in Drug Development (Part 2)
Time of Update: 2021-04-24
This plan was expected to save Pfizer 200 million US dollars at the time, while the new drug application documents for varenicline preparations and maraviiro preparations The new QbD paradigm not only increases the scientific details and understanding of the production process, but also advances the regulatory review and approval of the United States, Europe, and Japan.
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Well-known top tertiary hospitals strictly check medical representatives!
Time of Update: 2021-04-24
At the same time, the medical representative filing management measures stipulate that medical representatives shall not perform the following behaviors: conduct academic promotion and other activities without filing; undertake drug sales tasks, implement sales activities such as collecting payments and processing purchase and sales receipts; participate in the statistics of the number of drug prescriptions issued by individual doctors, etc.
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Ding Xueguo, general manager of unnamed medicine, resigns
Time of Update: 2021-04-24
On April 11, Weiming Pharmaceutical issued an announcement stating that the board of directors had received a letter from the chairman of the company regarding Ding Xueguo's resignation as the general manager of the company.
At this point, Ding Xueguo will no longer hold the post of general manager of Xiamen Weiming Biomedical Co.
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Acadi blockbuster dementia drug Nuplazid rejected by FDA
Time of Update: 2021-04-24
And Acadia pointed out that they had previously reached an agreement with the psychiatric research department supervised by Billy Dunn on the design of the drug’s key phase 3 clinical study HARMONY, which is aimed at analyzing as a single group A broad population of DRP patients.
