Portfolio News

Aetion Urges FDA To Establish Cloud-Based RWE Platform

Aetion has issued a call for the FDA to implement a cloud-based real-world evidence (RWE) platform with robust data governance so that users can do data queries, archiving, access, and aggregation. Such a system, the company says, could help avoid unnecessary data duplication and support concurrent reviews by global regulators. The FDA was going to discuss its September 2019 Technology Modernization Action Plan, an overarching plan that could include the use of RWE, at a meeting on March 27, but the meeting was rescheduled for June...

GRAIL Announces $390 Million Series D Financing

GRAIL announced that it has completed a $390 million Series D financing round. New investors including Public Sector Pension Investment Board (PSP Investments), Canada Pension Plan Investment Board (CPP Investments), and two undisclosed investors joined existing backers including Illumina in this round of funding. “GRAIL is making significant progress with our blood-based, multi-cancer early detection test,” said GRAIL CEO Hans Bishop. “Nearly 80 percent of cancer deaths result from cancers for which there is no screening test today, and GRAIL’s mission is to change that through...

With contact tracing, don’t let perceptions of big tech be the enemy of the greater good

Experts say the U.S. will need about 300,000 human tracers to chart and break ongoing expansion of the coronavirus pandemic, but we currently only have between 8,000 and 14,000. In a recent Rock Health post, the firm recommends combining a surge in human tracers, digital technologies to capture and share accurate and timely data with public health departments, and the will for public health organizations to share this data with people at the community level. Big tech is stepping up to play a part: on April...

Novartis receives CHMP positive opinion for Enerzair® Breezehaler® (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma

Novartis has announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of its Enerzair® Breezehaler® as a maintenance treatment of asthma in adult patients not adequately controlled with currently recommended maintenance drugs who experienced one or more asthma exacerbations in the previous year. The European Commission (EC) reviews the CHMP recommendation and usually delivers its final decision in about two months. If approved, Novartis’s new medication will be the first asthma treatment...

‘The world will never be the same’: Healthcare executives say telehealth is here to stay beyond the coronavirus

One benefit of the coronavirus pandemic is the increasing usage of telehealth. The virus has forced an end to many non-urgent medical visits, and doctors are connecting with COVID and non-COVID patients virtually. According to Dr. Roy Schoenberg, CEO of telehealth company Amwell, telehealth has gone from a “gratifying new technology” to something that’s taken on a life of its own. Business Insider’s Lydia Ramsey talked with Schoenberg and Dr. David Houghton, the system chair of telemedicine and digital health for Louisiana-based Ochsner Health during a...