Phase II
Roche and Austria-based Hookipa Pharma tied up a licensing and research and development collaboration valued at more than $950 million focused on KRAS-mutated cancers.
While worthy advances have recently been made in sickle cell disease, companies such as Graphite Bio, bluebird bio, Vertex Pharmaceuticals and Editas Medicine have loftier ambitions.
A Phase II trial studying PTC Therapeutics’ PTC518 in Huntington’s disease has been paused in the United States following a request from the FDA for additional data.
Salarius Pharmaceuticals voluntarily paused enrollment of its Phase I/II trial of seclidemstat for Ewing sarcoma and FET-rearranged sarcomas after a patient’s death.
GlaxoSmithKline (GSK) announced Tuesday morning it has struck a $70 million deal with Tempus in exchange for expanded access to Tempus’ AI-based patient data platform.
As part of its third-quarter report, Roche announced it has cut two Phase II programs, one for hepatitis B and the other for geographic atrophy, a form of eye disease.
An analysis of un-blinded interim data showed fosgonimeton provided clinically meaningful improvements in cognition and function in patients with mild-to-moderate Alzheimer’s disease.
The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.
Pfizer and BioNTech released early data Thursday morning from a Phase II/III trial assessing an Omicron-specific booster that showed it provided significant protection, confirming early research.
Relmada Therapeutics’ RELIANCE III trial studying REL-1017 as a treatment for Major Depressive Disorder failed to hit the primary endpoint, the company reported Thursday.
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