Search Results for “Clinical Trial” – Page 29 – media

Selecta, Sobi rout gout in pair of phase 3 trials that could challenge Horizon

On March 21, Selecta Biosciences and Sobi announced positive pivotal results from two phase III studies (DISSOLVE I and DISSOLVE II). These two placebo-controlled, randomized clinical trials were designed to evaluate the safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout. Gout is an autoinflammatory disease in which patients experience severe pain and debilitating inflammatory arthritis due to deposits of pro-inflammatory sodium urate (MSU) crystals. Patients with chronic refractory gout often have a high tissue MSU burden, which can lead to frequent gout attacks and chronic arthritis. Gout is the most common inflammatory arthritic disease in the United States. SEL-212 has the potential to reduce serum uric acid and MSU deposition in patients with chronic refractory gout. Recombinant uricase is highly immunogenic in the human body. Through Selecta’s proprietary ImmTOR platform, SEL-212 has the potential to alleviate the formation of anti-drug antibodies, ...
- Source: drugdu
- 151
- March 24, 2023
Chasing Pfizer, GSK’s 5-in-1 meningococcal vaccine delivers phase 3 trial win

Nearly three years after dosing the first patient in a phase 3 trial, GSK has now reported positive results from the trial of its much-anticipated combination meningitis vaccine. The shot, a combination of GSK’s approved vaccines Bexsero and Menveo, targets meningitis and blood poisoning caused by the A, B, C, W, and Y groups of meningococcal bacteria. The serogroups A, B, C, W and Y cause nearly all invasive meningococcal disease (IMD) cases globally, GSK said in a statement. As it stands now in the U.S., protection from all five groups requires four injections from two separate vaccines. But GSK is looking to change that with its two-dose shot, which is administered six months apart. GSK said that the vaccine candidate met endpoints in the trial, which enrolled healthy people between 10 and 25 years of age. The vaccine matched up to Bexsero and Menveo, eliciting a “clinically meaningful immune response.” https://www.fiercepharma.com/pharma/gsks-combination-menabcwy-vaccine-holds-its-own-against-gsks-approved-meningitis-jabs
- Source: drugdu
- 124
- March 16, 2023
Sanofi halts venglustat clinical programme in ADPKD

French pharma company Sanofi has announced that it has halted the clinical programme of venglustat in autosomal dominant polycystic kidney disease (ADPKD). Although the safety profile of venglustat remains consistent with previously reported results, a Phase II/III trial of the drug did not meet its futility criteria. In addition, the study confirmed venglustat effectively inhibits the glycosphingolipid (GSL) pathway by demonstration a reduction in the lip GL-1. The STAGED-PKD study was stopped for futility after an independent analysis of the annualised rate change in total kidney volume (TKV) in patients receiving venglustat compared to placebo. In a statement, Sanofi said that trends from this analysis showed venglustat did not provide meaningful reduction in TKV growth rate – the primary endpoint of stage one of the study. The company added that the analysis suggests the reduction of GSLs may not play a significant role in the prevention of kidney cyst growth, meaning ...
- Source: drugdu
- 277
- June 2, 2021
Sanofi
China’s Sinovac reports mixed findings in early coronavirus vaccine trials

A man works in a laboratory of Sinovac Biotech in Beijing on Sept. 24. The Chinese company is developing an experimental coronavirus vaccine. (Thomas Peter/Reuters) By Eva Dou November 18, 2020 at 5:09 p.m. GMT+8 Sinovac Biotech, one of China’s coronavirus vaccine front-runners, published mixed findings from its two first clinical trials Tuesday, raising the stakes in Indonesia, which has already declared plans to roll out Sinovac’s vaccine. While the vaccine appeared to be safe in these early clinical trials, the company reported that it generated lower levels of protective antibodies in the bloodstream compared with those arising in recovered coronavirus patients. In comparison, Moderna and Pfizer, which have separate experimental vaccines, had reported antibody levels on par with or higher than those produced in recovered coronavirus patients. These early results put Sinovac on the back foot to prove its vaccine is effective in ongoing Phase 3 trials. “That is a concern,” ...
- Source: drugdu
- 143
- November 19, 2020
Covid-19
GE Healthcare Launches Phase III Trial for Using Flurpiridaz 18F Injection to Detect CAD

GE Healthcare has launched a second phase III (AURORA) clinical trial for using Flurpiridaz 18F Injection in positron-emission tomography (PET) myocardial perfusion imaging (MPI), in order to detect coronary artery disease (CAD).
- Source: The Verdict
- 949
- August 6, 2018
Clinical Trials coronary arteries coronary artery disease
Tendyne Mitral Valve Replacement System U.S. Pivotal Trial Started by Abbott

A pivotal clinical study in the U.S. on the Tendyne Transcatheter Mitral Valve Replacement (TMVR) system for treating mitral regurgitation has been commenced by Abbott.
- Source: MPO Mag
- 1,118
- July 31, 2018
Abbott Clinical Trials heart valves medical device
Monoclonal Antibody Delays Cognitive Decline, Erases Alzheimer’s Plaques in Phase 2 Trial

A phase 2 study on BAN2401, a monoclonal antibody that hits soluble amyloid beta oligomers, showed that it limits cognitive decline in patients with slight cognitive injury or premature Alzheimer’s dementia on two scales and removed brain amyloid in 81% of patients in the trial.
- Source: MDEdge
- 944
- July 30, 2018
Alzheimer's disease Clinical Trials FDA
Assembly Biosciences Initiates Phase 2a Trial for its Lead HBV Core Inhibitor

U.S. based public biotechnology company, Assembly Bioscience revealed the launch of two randomized control phase 2a trials for its leading hepatitis B core inhibitor in a press release.
- Source: Healio
- 986
- July 17, 2018
Clinical Trials hepatitis B
XANTUS Programme Confirms Low Bleeding and Low Stroke Rate with Xarelto® in Patients with Atrial Fibrillation

An analysis of Bayer's XANTUS programme revealed the safety profile of the oral Factor Xa inhibitor Xarelto® (rivaroxaban) in clinical practice.
- Source: WorldPharmaNews
- 632
- July 14, 2018
cardiac heart attacks Researches
Viscofan to Trial Stem Cell Implant for Severe Cardiac Insufficiency

Viscofan BioEngineering, a German medical products manufacturer is to conduct a Phase I clinical trial of its stem cell implant, VB-C01, designed to treat severe cardiac insufficiencies, on receiving a green light from the Spanish Agency for Medicines (AEMPS).
- Source: Verdict Medical Devices
- 752
- July 10, 2018
cardiovascular Researches stem cells

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