manufacturing
. Saniona anticipates that addressing these requests will delay the start of the Phase 2b trials of Tesomet for Prader-Willi syndrome (PWS) and hypothalamic obesity (HO) into the second half of 2021.
Tesomet is an investigational fixed-dose combination of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). In preparation for Phase 2b through Phase 3 clinical trials and eventual commercialization, Saniona has taken multiple steps to optimize the manufacturing of Tesomet, including transitioning from tablets to capsules. The company chose to utilize a capsule form because some individuals with PWS and HO have a tendency to chew tablets, which would disrupt the performance of the fixed-dose combination. The Tesomet capsules contain the two active ingredients as microspheres, which are expected to minimize the impact of chewing or biting. Additionally, capsules are generally easier to swallow than tablets and facilitate the dev
Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U S FDA apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.
Homology Medicines Announces Promotion of Tim Kelly to Chief Operating Officer
April 12, 2021 08:30 ET | Source: Homology Medicines, Inc. Homology Medicines, Inc. Bedford, Massachusetts, UNITED STATES
- Built Internal GMP Commercial Process and Manufacturing Platform and Scaled HEK293 Suspension System to 2,000L Under His Leadership -
BEDFORD, Mass., April 12, 2021 (GLOBE NEWSWIRE) Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today that Tim Kelly has been promoted to Chief Operating Officer, effective immediately. Previously, Mr. Kelly held the role of Chief Technical Operations Officer and led the construction of the Company’s internal 25,000-square-foot GMP manufacturing facility, which was completed in 12 months from design to operation. As one of the first companies to scale to a 2,000-liter bioreactor with a HEK293 serum-free suspension system, Homology’s commercial scale process a
Homology Medicines Announces Promotion of Tim Kelly to Chief Operating Officer streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
December 21, 2020
Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced the further expansion of its executive team with the appointments of Denelle Waynick as Chief Legal Officer and Kyle
Haraldsen as Chief Technical Operations Officer. The positions will be based in the U.S. and will support Saniona’s advancement of clinical trials for Tesomet and SAN711 as well as the company’s growing U.S. presence.
“This has been a year of transformation for Saniona, evolving from a company focused on early-stage research to one capable of conducting its own mid-stage clinical trials. As we close out 2020, the hiring of Denelle and Kyle completes Saniona’s executive team in support of our current business,” said Rami Levin, President and CEO of Saniona. “As we look to 2021, our entire organization is focused on initiating Phase 2b clinical trials of Tesomet in HO and PWS, as well as advancing SAN711, the first drug candidate