The FDA has reorganized and elevated its health IT, data management and cybersecurity efforts into a single, new office that will report directly to the commissioner. The move comes as part of the agency’s wider modernization strategy as it continues to face ever-increasing amounts of clinical data.
Mutations in tumor-suppressing genes are known to drive cancer, but how? Scientists long believed that the mutations prompted the cancerous cells to grow unchecked. But a new study out of Howard Hughes Medical Institute suggests the story is more complicated than that.
A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing.
Protagonist Therapeutics’ treatment for a rare, slow-growing blood cancer is under an FDA clinical hold after the company reported safety concerns in a nonclinical mouse study.
ESMO: Novartis links prostate cancer drug to improved pain, quality of life as regulatory filings near
Novartis is building the case for its radioligand therapy. With positive phase 3 primary endpoint data in the bag, Novartis arrived at the European Society of Medical Oncology Congress 2021 armed with evidence of the therapy’s effect on quality of life and pain.
AstraZeneca is following suit of many other pharmas and tapping academic and cancer organizations to fill out its oncology research team.
Elevian thinks it has the tools to treat age-related diseases and will start by testing its drug in one of the leading causes of death: strokes. The Massachusetts biotech raised $40 million to bankroll studies based on research that emerged out of Harvard in the early 2010s.
Vifor doles out $55M upfront to license Travere’s late-stage kidney asset slated for US filing next year
A gloomy outlook in May has turned into a potential $190 million future for Travere Therapeutics’ late-stage kidney asset.
Intellia has shown that gene editing works in the body, and now the biotech is going to try to prove the same outside of the body.
Aerie Pharmaceuticals earned the ire of Bio Twitter and investors Wednesday night after dropping a failed midstage study after-hours, then whitewashing the flop and insisting a phase 3 would go ahead anyway.