Industry News

The Time is Now. The pharmaceutical industry is laden with issues and inefficiencies that, as of late, have been illuminated and exacerbated. Much of the issue lies in the industry’s sluggish digital transformation as so many of the shortfalls that the system currently grapples with, would be largely improved with the assistance of technology. There […]

Great read on the latest COVID-related regulatory developments, namely the FDA’s announcement on treatment efficacy thresholds for upcoming vaccines.   A week after the US Food and Drug Administration (FDA) issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and Research, shed light on the reasoning […]

  There has never been a greater need for technological integration into healthcare practices as there is now. The COVID-19 pandemic has highlighted the limitations and difficulties of the healthcare industry, which up to this point, has been sluggish to adopt many of the advancements necessary to mitigate the current strains. Fortunately, the race to […]

There are numerous challenges of discovering, developing, and testing a treatment for COVID-19 during this unprecedented time. While the goal of finding a treatment is universal, there is a wide array of avenues through which this can be achieved, and each must weight the obvious urgency with the overarching necessities of safety and efficacy. Here, […]

Prior to the massive changes and limitations brought forth by the outbreak of COVID-19, clinical trials had an outdated approach to many of their processes, with effects extending through development phases, the collection of patient data, regulatory processes and numerous others. While COVID-19 has created immense difficulties, it also forces the integration of technology and […]

With increased limitation in the capacity to develop, plan, and execute regulation-abiding clinical trials, there is growing concern surrounding the best tactics to proceed forward.   The coronavirus pandemic has thrown a wrench into plans for hundreds of clinical trials. But some investigators and sponsors are pushing ahead. Source: Patients, drug makers grapple with cancer […]

  When the effects of COVID-19 took root in the US, a shift away from typical routines was triggered, one which brought far reaching repercussions. In all areas of life, this pandemic has forced change, no matter the feasibility of adapting to such change. Where clinical trials are concerned, the adjustment has proven difficult, while […]

MVG Insights In lieu of the COVID-19 outbreak, the FDA has issued 3 clinical guidances outlining new protocols related to the following: REMS requirements, alcohol-based sanitizer production, and the conduct of clinical trials of medical products. Each guidance resulted directly from the need for current protocol adaptation to address unmet needs due to COVID-19. 1. REMS […]

Interesting read on the vaccine for COVID-19. While the speed at which Moderna has been able to progress their vaccine is impressive, it also raises many questions surrounding the bioethics of expediting such processes in the face of imminent need. Ethicists aren’t so sure that the eventual benefits of rushing this unproven vaccine into clinical […]

Exciting news for Lupus Nephritis from the FDA. Discover the latest news about our company, our products, our policies, and our people. Source: Genentech: Press Releases | Tuesday, Sep 17, 2019