FDA announces overhaul of medical device approval system
November 28, 2018
By Neozene

The FDA plans to overhaul the decades-old medical device approval system that has been criticized by experts for risky implants and failure to catch problems, it announced Monday. The decision comes one day after an investigation on global medical device safety was published by the International Consortium of Investigative Journalists (ICIJ) — with over 250 journalists from more than 50 organizations helping with the investigation. The investigation found more than 1.7 million injuries and almost 83,000 deaths may have been linked to medical devices over a 10-year period in the

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Zika vaccine turns up positive early-phase data
November 21, 2018
By Neozene

A Zika vaccine candidate co-developed by Emergent BioSolutions and Valneva has turned up positive early-stage results, laying the groundwork for a potential technology transfer to Emergent. The alum-adjuvanted, inactivated vaccine candidate, dubbed VLA1601, was found to be safe in a phase 1 trial, meeting its primary endpoint. It also induced immune responses, as neutralizing antibodies against the Zika virus were observed in a dose- and schedule-dependent way, the pair reported on Monday. Seroconversion rates reached as high as 85.7% on day 35 among all 67 adults who received either one

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Quantum Genomics’ brain-targeting blood pressure drug meets phase 2b endpoints
November 13, 2018
By Neozene

Quantum Genomics’ blood pressure drug firibastat, an inhibitor that targets aminopeptidase A in the brain, met its primary endpoint in a phase 2b study—which the company says paves the way for a wider phase 3 trial in more resistant hypertension. Firibastat lowered systolic automatic office blood pressure, or AOBP, by 9.7 mm Hg compared to baseline readings in patients with arterial hypertension, while lowering diastolic pressure by 4.3 mm Hg. Both endpoints reached P values of less than 0.0001. “A minimum decrease of 7 mmHg in systolic AOBP represents a

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