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FDA clears Pfizer, Arvinas’ novel breast cancer therapy despite mixed data
The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual discussion” about the design of AstraZeneca’s Phase 3 trial of camizestrant in HER2-negative advanced breast cancer, former cancer regulator Harpreet Singh told BioSpace.
Summit Therapeutics planned an early interim progression-free survival readout for HARMONi-3 in the hope of enabling earlier regulatory engagement—but the early analysis delivered disappointment for the company and shareholders.
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STAT+: Biotech raises $42 million to run Huntington’s disease trial
Gene therapy startup Latus Bio has raised another $42 million to start its first clinical trials, where it will try to sidestep issues that have set back a more advanced competitor.
Latus is moving two treatments through clinical trials this year. The first is for a form of Batten disease called CLN2 disease, a fatal genetic condition that causes seizures, vision loss, and cognitive problems. The company anticipates having initial clinical data by the end of the year.
Now, Latus — founded by Beverly Davidson, chief scientific strategy officer at the Children’s Hospital of Philadelphia — is turning its attention to a second drug candidate, a gene therapy for Huntington’s disease.
Gene therapy startup Latus Bio has raised another $42 million to start its first clinical trials, where it will try to sidestep issues that have set back a more advanced competitor.
Latus is moving two treatments through clinical trials this year. The first is for a form of Batten disease called CLN2 disease, a fatal genetic condition that causes seizures, vision loss, and cognitive problems. The company anticipates having initial clinical data by the end of the year.
Now, Latus — founded by Beverly Davidson, chief scientific strategy officer at the Children’s Hospital of Philadelphia — is turning its attention to a second drug candidate, a gene therapy for Huntington’s disease.
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial
Summit shares descend as PD-1/VEGF asset misses early survival mark
FDA clears Pfizer, Arvinas’ novel breast cancer therapy despite mixed data
STAT+: Biotech raises $42 million to run Huntington’s disease trial
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What is your AI drug repurposing strategy missing?
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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