Research and development daily Pfizer's new crown vaccine clinical trial volunteers have side effects

2020.09.16 Research and Development NEWS: Clinical success of Glynasterone Rare Epilepsy Phase III; Colum, Baotai After Junshi/Multi-Jubilee BioTrop2 ADC Drug Start-up Clinical; FDA Grants Blinger/Lilly SGLT2 Inhibitor Jardiance Fast Track Qualification; Qilu Pharmaceuticals "Selesib Capsules" Approved for Market ... We focus on the latest developments in pharmaceutical research and development, to provide research and development personnel with timely and accurate information reference.
(click on the title, read the original) "Drug Development" Gana ketone rare epilepsy phase III clinical success days ago, Marinus announced that its neurosteroid drug ganaxolone in a rare epilepsy called CDKL5 deficiency (CDD) phase III clinical end of the trial.
the trial, called Marigold, recruited 101 CDD patients to compare the effects of ganadone and placebo on the frequency of epilepsy.
results were 32 per cent lower than the frequency of pre-drug morbidity during the 28-day observation period, compared with a 4 per cent decrease in placebo.
the trial missed several secondary finishes, and the placebo performed slightly worse than expected.
Xinhua) -- Volunteers using the company's new crown vaccine or placebo showed mild to moderate side effects in an ongoing late-stage clinical study of the new crown vaccine, U.S. pharmaceutical company Pfizer said on Wednesday, Reuters reported.
side effects include fatigue, headaches, chills and muscle pain, the company said.
volunteers in the trial also developed fever symptoms, including a high fever.
For multidrore bacterial infection Yunding Xinyao joint therapy China Phase 1 trial obtained positive results on the 15th, Yunding Xinyao announced the results of a phase 1 clinical trial conducted in China for the treatment of multidrore bacterial (MDR) infection with the taniborbactam joint cephalosporine
the study achieved its main objectives, and the results showed that the combined treatment of cephalosporineand taniborbactam had good safety and tolerance among healthy Chinese volunteers, and no racial differences were found in the key pharmacodynamic parameters.
the first clinical announcement of the ADC drug JS108 (DAC-002) phase I clinically initiated clinical 15th Junshi/Multi-Jubilee drug after Colum and Beotai.
this is the fourth domestic into the clinical stage of the Trup2 ADC, after the domestic has been Baiotai, Colum, Yunding Xinyao's same target ADC start clinical.
(Drug Approval) Gilead Anti-CD47 Single Resistance FDA Breakthrough Therapy Recognition Treatment MDS Gilead Science announced today that the FDA has awarded the "first-in-class" anti-CD47 monoclonal antibody magrolimab breakthrough therapy to identify the adaptive disorder as newly diagnosed bone marrow growth syndrome (MDS).
fda grants Bronger/Lilly SGLT2 inhibitor Jardiance fast-track eligibility! The Lilly-Blainger Ingelheim Diabetes Alliance recently announced that the FDA has granted fast-track eligibility for the SGLT2 inhibitor class of sugar-lowering drug Jardiance (Chinese: O'Donnell ®, common name: empagliflozin, engliflozin, Ngle net) for patients with an acute myocardial infarction (often referred to as heart attack), to prevent hospitalization and reduce the risk of death from heart failure.
C3 inhibitor pegcetacoplan filed for listing in the U.S. and Europe, the company announced that it had submitted a new drug application to the U.S. FDA and a marketing authorization application to the European EMA seeking approval for the C3 inhibitor pegcetacoplan (APL-2) for the treatment of cystic sleep haemoglobinuria.
Aico 1st class of antiviral new drugs to be included in the breakthrough treatment varieties CDE latest public announcement, Aycobacters 1.1 new drugs AK0529 intestinal capsules were included in the proposed breakthrough treatment varieties on September 15th.
this is a product under study that is included in the list in paragraph 5 of the CDE publicity.
Takeda HyQiva has been approved by the European Union to update the label: Takeda for adults, adolescents and children recently announced that the European Commission (EC) has approved the HyQvia label update to expand its use to make it the first and only easy-to-use subsocisive immunoglobulin replacement therapy for a wider group of patients with secondary immunodeficiency, including adults, adolescents and children.
Hengrui Pharmaceutical's 3rd approved listed 14th, Hengrui Pharmaceuticals 4 classes of generic drug proxantan chloride tablets (I.) was approved by the State Drug Administration for listing, becoming the third domestic manufacturer after Baiao Pharmaceuticals, Garden Pharmaceuticals approved the variety.
3 compound preparations through the consistency evaluation 16, the official website of the Drug Administration shows that 3 compound preparations through the consistency evaluation, respectively, East China Medicine's pyridoxine metformin tablets, North China Pharmaceutical's Amoxilin Kravy acid tablets and Fuyuan Pharmaceuticals' chlorosatan potassium hydrochloride tablets.
, the 12 are the first to pass a consistency evaluation.
Qilu Pharmaceutical "Selesib Capsules" was approved for listing on the 16th, the Official Website of the State Drug Administration shows that Qilu 4 classes of generic drugs "Selesib Capsules" were approved for listing, as if through a consistent evaluation.
Research and Development Cooperation: Insignial Biologics and Pharmaceutical Stone Technology signed a strategic cooperation agreement on innovative drug research and development Inshi Bio and Pharmaceutical Stone Technology announced that the two sides recently reached a strategic cooperation agreement on innovative drug research and development, and identified a number of innovative anti-tumor new drug compounds currently under study by Pharmaceutical Stone Technology as the first carrier of cooperation, including technology transfer and joint development, including a series of cooperation.