Opinion &amp; analysis

DECIEM, Truly ‘The Abnormal Beauty Company,’ Faces Uncertain Future

“Almost everyone at Deciem has been involved in a major criminal activity.” So claimed Deciem Inc. founder Brandon Truaxe on an October 8 Instagram post in which he also announced the controversial Estee Lauder Companies-backed startup would be ceasing operations “until further notice.” Find out more here.

October 9, 2018

Real-World Evidence: US FDA’s Prucalopride Review Shows Datasets’ Utility And Limitations

Although criticism was leveled at the use of real-world datasets in the US FDA advisory committee review of Shire PLC’s constipation drug Motegrity (prucalopride) with worries raised over its lack of race-related patient information, a European pharmacoepidemiology study allayed concerns regarding its cardiovascular safety.

October 23, 2018

Drug/Software Combo Platform Coming Soon To US FDA, Gottlieb Says

Explore the details behind the FDA digital health tools platform set for release in the fall of 2018, an initiative designed to allow health software applications and accompanying new drugs to be approved concurrently, further streamlining the approval process for certain combination products.

October 24, 2018

Part B Payment Model Indexing Commercial Discounts Proposed By Genentech

Stay aware of proposed changes to the existing Medicare Part B average sales price (ASP) payment system. Explore Genetech’s “Market-based Pricing Model”, as well as changes to the existing competitive acquisition program, and the possibility of moving Part B drug coverage to Part D in this essential article.

October 23, 2018

Adaptive Clinical Trial Designs: US FDA Provides Checklist To Begin Study

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On September 28, 2018, the US FDA issued new draft guidelines for adaptive clinical trial designs, as well as additional guidance updates. Tap into these important updates, which replace draft guidance issued by the agency in 2010.

September 30, 2018

Telehealth Reforms Praised At Senate Hearing

Insurers and a neurologist testifying at a May 16 Senate Finance Committee hearing on the CHRONIC Care Act praised the bill’s telehealth provisions. Committee Chairman Orrin Hatch, R-Utah, says he plans to mark up the bill, which has been under development for two years, this week.

Technology Gap Separates OTC Drug Firms From SelfCare Sales Growth

OTC drug firms should offer more digital tools that guide consumers in product purchases, says a health care marketing executive. The American Pharmacists Association suggests firms also strengthen outreach with pharmacists.

Reckitt Reaps ROI Reward In Geo-Targeted Symptoms App Promoting Mucinex, Delsym

RB’s spending on the WebMD-hosted Cold & Flu Tracker app generated an ROI three times greater than traditional digital marketing, says marketing executive Emma Howe. Similar campaigns are gaining momentum, with WebMD and Walgreens launching “Relief Advisor.”

Philips To Create More Context, Connectedness And Continuity And Shift Sick Care To Health Care

Connected care technologies play an important role in disease prevention, but are still not used as widely as they should be. Philips’ second Future Health Index study surveyed 33,000 participants in 19 countries to compare perceptions and experiences of healthcare users across three areas – access to care, integration of health systems and adoption of connected care technologies.

Game On For Akili’s Cognitive Control Tech

A digital video game developed by Akili Interactive Labs for treating cognitive disorders has demonstrated in a pilot study its ability to improve cognitive control test scores of neurotypical children and children with sensory processing dysfunction (SPD).

Engaging Patients and Navigating Laws: What To Consider When Developing Health Apps

Victoria Hordern and Amy Merrick discuss initiatives in the EU to help app developers navigate the unclear rules on mobile health and explain why engaging patients during product development is key.

Biogen CMO Notes iPhone’s Potential For Early Detection of Alzheimer’s

Biogen’s chief medical officer says iPhone technology should in future be used for early warning diagnosis of Alzheimer’s Disease. Biogen CMO Alfred Sandrock has told a London neuroscience forum that constraints impeding CNS drug development include the fact diagnosis needs to be done earlier but that barrier could be mitigated in future by digital health solutions such iPhones used as “early warning” diagnostics, notably in Alzheimer’s Disease.

Behind The Scenes Of Digital Health: Medtech Players And Partners

The digitalization of health care has been much talked about over the last decade or so. But activity among the medical device manufacturers and service providers has only just recently accelerated as they start overcoming barriers and resistance to this new way of delivering health care.