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Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeutics’ PI3KA inhibitor in treating vascular malformations (VM), prompting the biotech to eye a potential path to accelerated approval.
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Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against the potential Emergency Use Authorization of the company’s COVID-19 therapeutic candidate, sabizabulin.
AstraZeneca will give up on seeking approval for its COVID-19 vaccine in the United States. It is also abandoning three early-stage programs.
An anti-CD70 antibody drug conjugate developed by Ambrx, Inc. has been administered to the first patient in a Phase I study in China. It marks the first ADC in active development that targets CD70.
A gene therapy being developed by Eikonoklastes Therapeutics to treat ALS received Orphan Drug Designation, the company announced Wednesday.
Third Rock-founded Faze Medicines appears to be shuttering operations, with several former employees signaling they are looking for new jobs.
Oncolytics Biotech released data Thursday from a Phase I/II study in pancreatic ductal adenocarcinoma that support plans to advance the program into Phase III.
With a fresh $18 million in the bank, NRG Therapeutics is ready to put its novel mitochondrial approach to the test for devastating neurodegenerative disorders—Parkinson’s and ALS.
At the foundation of every clinical trial are the professionals who ensure its successful execution. Read on to find out more about how to know if clinical research is right for you.
Bankruptcy might be looming for embattled Clovis Oncology, the company warned Wednesday in a 10-Q filing. Clovis also revealed it has taken action to reduce its workforce by 115 employees.