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How do Qilu and Yilian Biopharmaceuticals add next-generation ADC drugs?
Time of Update: 2021-04-24
ADC drugs are mainly composed of three parts: antibody, linker (Linker) and cytotoxic drug (Payload), but the development of a successful ADC drug is by no means a simple addition, but an organic result of adjustment and optimization of each component.
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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.
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Hengrui Medicine HR19042 capsule was approved for clinical use in the treatment of primary IgA nephropathy
Time of Update: 2021-04-24
On December 31, 2020, Hengrui Medicine submitted a clinical trial application for this product to the National Food and Drug Administration for the treatment of primary IgA nephropathy.
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Xianju Pharmaceutical Receives Acceptance Notice for Consistency Evaluation of Dexamethasone Sodium Phosphate Injection
Time of Update: 2021-04-24
On April 6, Xianju Pharmaceutical issued an announcement stating that it had recently received a notice of acceptance of the consistency evaluation of dexamethasone sodium phosphate injection issued by the State Food and Drug Administration.
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Eli Lilly/GSK/Vir jointly announces expanded Phase 2 BLAZE-4 test top-line data
Time of Update: 2021-04-24
In addition, in terms of the key virological secondary endpoint of the new coronavirus (SARS-CoV-2) viral load from baseline inspection to the average change on days 3, 5, and 7, compared with placebo, the combination of bamlanivimab and VIR-7831 The use of the drug resulted in a statistically significant reduction in viral load.
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Kelun Pharmaceutical's Propofol Fumarate Tenofovir Tablets Obtained Drug Registration Certificate
Time of Update: 2021-04-24
On April 13, Kelun Pharmaceuticals issued an announcement stating that the company had recently obtained the "Drug Registration Certificate" for the chemical drug "Propofol Fumarate Tenofovir Tablets" approved and issued by the National Medical Products Administration.
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How to Train Your Dragon: TG6002
Time of Update: 2021-04-24
The design concept of chemotherapeutic drugs like 5-FU is to simply kill tumor cells that replicate faster, but the actual working mechanism is more complicated.
Therefore, in addition to selectively killing tumor cells, oncolytic viruses have a more important purpose for immune activation.
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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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Roche's new indication of ``Eimerizumab'' will be approved soon
Time of Update: 2021-04-24
According to the public information of the prior priority review, the indications that will be approved this time are: routine preventive treatment for adults and children with hemophilia A (congenital factor VIII deficiency) without clotting factor VIII inhibitors.
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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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Where does the original research drug go?
Time of Update: 2021-04-24
Coincidentally, not long ago, Eli Lilly China announced internal adjustments to the sales and regional marketing team of Enpagliflozin (trade name: Ou Tangjing), as well as duloxetine hydrochloride (trade name: Xinbaida) and tadala.
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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).
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Langlai Technology's IRAK4 inhibitor MY004 clinical trial application was accepted by NMPA
Time of Update: 2021-04-24
The purpose of the clinical study of MY004 application acceptance is to explore the safety, tolerability and pharmacokinetic properties of the drug in healthy subjects.
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Pfizer's new crown vaccine stimulates a strong immune response in adolescents and has a preventive effect of 100%
Time of Update: 2021-04-24
Today, Pfizer and BioNTech jointly announced that the new crown vaccine BNT162b2 jointly developed by the two parties has shown 100% efficacy and a strong antibody immune response in a phase 3 clinical trial conducted in adolescents aged 12-15.
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Announcement of audit results of pharmaceutical companies!
Time of Update: 2021-04-24
, Ltd. The inspection found that the company had the following problems: First, its affiliated Xinyi Pharmaceutical Business Department inflated travel expenses of RMB 20,033,600 in 2018, which were listed as fueling invoices, but could not provide details of the recharge card number, expense approval form and other information.
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Hisun Pharmaceutical's tigecycline for injection passed the consistency evaluation
Time of Update: 2021-04-24
On November 21, 2018, the State Food and Drug Administration accepted the application for consistency evaluation of tigecycline for injection submitted by Hisun Pharmaceutical.
Up to now, Hisun Pharmaceuticals has invested about 9,730,300 yuan in the quality and efficacy consistency evaluation of the generic drug.
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Talking about: Sulfonate Drugs & Sulfonate Gene Toxicity
Time of Update: 2021-04-24
WenJohnsonIn recent years, the review of genetic toxic substances by the drug review department has become stricter and more demanding. Are genotoxic substances detected? What is the potential risk?
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Starting from April, pharmaceutical companies that have not submitted a letter of trust will not be able to participate in new bids or online appeals!
Time of Update: 2021-04-24
In accordance with the requirements of the National Medical Insurance Administration, starting from April 1st, for pharmaceutical companies that have not submitted a "Pharmaceutical Enterprise Price and Marketing Behavior Credit Commitment", the provincial centralized procurement agencies will no longer accept their new bids or online appeals.
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Livzon Pharmaceutical's triptorelin pamoate microspheres for injection received clinical approval
Time of Update: 2021-04-24
On April 7th, Livzon Pharmaceutical issued an announcement stating that the company and its wholly-owned subsidiary Livzon Microspheres have recently received the approval of triptorelin pamoate microspheres for injection from the State Food and Drug Administration.
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Mitsubishi Tanabe Pharmaceutical's CD19 monoclonal antibody Uplizna approved in Japan
Time of Update: 2021-04-24
Mitsubishi Tanabe Pharmaceutical Company (MTPC) recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the anti-CD19 monoclonal antibody Uplizna (MEDI-551, generic name: inebilizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD, optic nerve spinal cord) Inflammation) patients to prevent the recurrence of the disease.
