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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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Takeda's 100 microgram dose of Natpara will be withdrawn for 1 year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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Talking about: "Drug Patent Link System" of "Innovation & Imitation Communication Bridge"
Time of Update: 2021-04-24
Establishing a drug patent link system that suits national conditions usually has the following four important meanings: protecting the patent rights of original research drugs; encouraging generic drug patent challenges; establishing a standardized drug market access order to prevent malicious competition; and resolving patent disputes in established infringements.
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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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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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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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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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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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After four price cuts, Sharp Ass finally divested its proprietary Chinese medicine business for 82 million yuan
Time of Update: 2021-04-24
The transfer process can be described as a twists and turns, but it can also be seen that Sharp Ass' determination to spin off the proprietary Chinese medicine business——· From December 11, 2020 to December 17, 2020, the initial public listing and transfer of 100% equity of Qiangshen Pharmaceutical, with a reserve price of 195,428,100 yuan.
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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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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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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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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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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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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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Haisco HSK29116 obtained clinical approval in bulk
Time of Update: 2021-04-24
It is an oral Protac small molecule anti-tumor drug that can selectively block BTK kinase activity and interfere with B cell development by regulating signal pathways, thereby controlling various B cell malignant tumors.
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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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Zhao Jun, vice chairman and director of Osaikang, resigns
Time of Update: 2021-04-24
Zhao Jun’s resignation report will take effect from the date of delivery to the company’s board of directors, and the company will complete the company’s director by-election as soon as possible in accordance with relevant regulations.
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South Africa test data demonstrates 100% protection, Pfizer vaccine releases latest results
Time of Update: 2021-04-24
Today, Pfizer and BioNTech announced the latest results in a phase 3 clinical trial of the new crown vaccine BNT162b2 jointly developed by both parties.
Data from clinical trials conducted in South Africa where the new crown mutant virus strain B.
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The State Food and Drug Administration revises the drug instructions for cefuroxime oral preparations and injection preparations
Time of Update: 2021-04-24
Post-marketing surveillance found that this product had case reports of angioedema, severe allergic-like reactions, and anaphylactic shock.
Post-marketing monitoring found that this product still has case reports of hematuria, interstitial nephritis, and acute kidney injury (including acute renal failure).
