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Northwest Biotherapeutics, Inc.

http://www.nwbio.com/

Latest From Northwest Biotherapeutics, Inc.

Build Patient-Reported Outcomes Into Cancer Drug Dose Optimization, US FDA Says

In exploratory FDA analyses, PRO data appeared more sensitive at detecting an exposure-toxicity relationship for an oral small molecule cancer drug than clinician-reported data; Project Optimus representative dispels industry concerns that FDA wants firms to find the 'mythical' optimal dose.

Clinical Trials Research & Development

Long-Term Vitiligo Data Appear To Lay Opzelura Safety Concerns To Rest

Incyte’s topical JAK inhibitor carries a class-wide severe safety warning and cautions against chronic use, but 52-week results could ease the way for the potential vitiligo indication.

Dermatology Inflammation

Angion’s HGF Mimetic Fails Second Phase II Study, But Not Shuttered Yet

Although ANG-3777, partnered with Vifor, missed its primary endpoint in cardiovascular surgery patients at risk for acute kidney injury, the companies will consider a path forward based on a renal events measure.

Clinical Trials Drug Approval Standards

Vifor/Angion Collaboration On Rocky Ground As ANG-3777 Phase III Trial Fails In Kidney Transplant Patients

Vifor and Angion’s ANG-3777 has failed in a Phase III trial for kidney transplant patients at risk of delayed graft function less than a year after the companies sealed a $80m licencing deal for the product. As focus shifts to another rare nephrological indication, analysts express skepticism.

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