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NIH selects Emergex’s T cell vaccine for trials under Project NextGen. As part of the development, NIAID is expected to cover the entire cost of the Phase I clinical trial.
Alzheimer's trials: How does donanemab compare to lecanemab?
2023年1月13日 · Already, 2023 is shaping up to be an eventful year in Alzheimer’s disease (AD) drug development. After the FDA’s approval of Eisai/Biogen’s Leqembi (lecanemab) on January 6, the AD field is now looking toward the upcoming approval decision for Lilly’s donanemab expected in May. Although both donanemab and lecanemab have similar therapeutic targets, the two …
Gilead’s lenacapavir: HIV prospects strongest in long-acting …
2021年8月25日 · Gilead’s lenacapavir will find its strongest niche as a long-acting HIV combination treatment, experts said. Manasi Vaidya August 25, 2021. Gilead announced a collaboration with Merck in March to study lenacapavir with islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), which is also a new drug class in HIV.
Medidata and Aixial Group collaborate to streamline trial execution
2024年9月3日 · Credit: TippaPatt / Shutterstock. US-based clinical trial software company Medidata has partnered with contract research organisation Aixial Group to streamline clinical trial execution and attain database lock more quickly. Aixial will migrate clinical data from one of its business units onto the Medidata Platform to create a Single Source of ...
Viridian Therapeutics' stock jumps after Phase III trial met all …
2024年9月11日 · Viridian Therapeutics Inc. Amgen Inc. View all. The news saw the Massachusetts-based company’s stock price rise by 32% on 10 September, having closed at $14.19 on 9 September and $18.75 on 10 September. The trial met the primary and all secondary endpoints at 15 weeks after five infusions of veligrotug, showing highly statistically ...
Biomea’s stock bounces back as FDA lifts clinical hold on diabetes …
2024年9月27日 · Biomea Fusion’s stock is on the up after the company plans to resume two clinical trials evaluating its type 1 and 2 diabetes therapy after the US Food and Drug Administration (FDA) lifted a full clinical hold. In June, the US regulatory agency paused the trials of BMF-219 after reports of potential drug-induced hepatotoxicity emerged.
ProKidney drops Phase III CKD study to focus on US market and …
2024年9月4日 · ProKidney is dropping an ex-US Phase III study for its chronic kidney disease (CKD) cell therapy rilparencel, following discussions with regulatory experts and ex-US Food and Drug Administration (FDA) officials.
Top Ongoing mRNA Herpes Vaccine Trials - Clinical Trials Arena
2023年2月2日 · Pfizer and Moderna eye seasonal influenza. The two largest mRNA vaccine trials with readouts in 2023 are for seasonal influenza. First up, Moderna’s 6,102-patient, Phase III trial of mRNA-1010 (NCT05415462) has immunogenicity data expected in Q1 2023. The trial is testing mRNA-1010 against an active comparator vaccine, with primary endpoints ...
Neurocrine reports data from Phase II schizophrenia treatment trial
2024年8月29日 · Neurocrine Biosciences has reported positive top-line results from its Phase II clinical study of NBI-1117568, an investigational oral treatment for schizophrenia. Named NBI-‘568-SCZ2028, the study met its primary endpoint with a significant reduction in schizophrenia symptoms at a once-daily 20mg dose.
Wave’s stock swells as it eyes approval following Phase II DMD …
2024年9月25日 · Wave Life Sciences is eyeing an accelerated approval for its Duchenne muscular dystrophy (DMD) drug, with the company’s stock price soaring by more than 50% after Phase II trial data was unveiled. Patients in the Phase II FORWARD-53 trial (NCT04906460) benefitted from substantial dystrophin expression and the WVE-N531, an exon skipping ...
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