Probiotic labeling came under fire in a recent opinion piece published in JAMA Internal Medicine, which called for more detailed and extensive labeling for probiotic supplements, as well as improved good manufacturing practices (GMP) as they pertain to the production of products containing live microorganisms.
Despite remarks from the US President to the contrary, US pharmaceutical companies have not yet voluntarily lowered their prices. Health and Human Services Secretary Alex Azar discusses the reasons why, and delves into the use of regulations as a means of prohibiting rebates in this illuminating article from Pink Sheet.
At the recent Medidata NEXT London meeting, Medidata Solutions, Inc., explained their new Clinical Cloud solution, part of the new crop of clinical trials and data analysis tools that only a few years ago, seemed like a distant dream. Read how Clinical Cloud and other clinical trials tools are taking data analysis to new heights in this informative article.
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.
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.
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.
This technology report provides an overview of the current landscape for digital health devices and software. This includes a summary of regulation and reimbursement policies and highlights of major product categories.
This medical market and technology report provides a comprehensive discussion of the global market for neurointerventional cerebral aneurysm and AVM embolization systems. This market comprises the following product segments: endovascular coils, liquid embolics, stents for stent-assisted coiling, flow diversion and flow disruption systems, and other novel/emerging embolization devices. Markets covered by this analysis comprise the US, Japan, the five major European markets (France, Germany, Italy, Spain, and the UK), and the rest of world (RoW) markets. The forecast range for this report is 2020–25.
The ICD market alone lost nearly $1bn from $8.3bn in 2019 to $7.4bn in 2020 due to a combination of lockdowns, supply chain disruptions, and logistical strain in the healthcare space. The global market for ICD devices, along with many other medical devices, is currently recovering from a major economic downturn. Therefore, to provide context as to the nature of this market recovery and what exactly it is recovering from, data from 2019 are included. Types of cardiac defibrillators covered by the scope of this report include ICDs, subcutaneous ICDs (S-ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds). The regions covered by this report are the US, the 5 major European economies (UK, France, Spain, Italy, Germany), Japan, and the rest of the world. The forecast range is 2020-2025.
The 39th annual J.P. Morgan Healthcare Conference (JPM) was held virtually from January 11-14, 2021. A list of events and catalysts that were announced or updated at the conference are included in this report. Below are some key points from company presentations.
The post-market clinical follow-up requirements for device and diagnostics companies based on the new medtech regulations are complex. They contain vague terms that need clarification for companies to understand how to comply. Expert and consultant Sarah Sorrel provides her interpretation in this interview with Medtech Insight.
With higher standards and new, demanding regulations for EU notified bodies, six notified bodies have been called into question by the European Commission. All are listed with warnings on the Commission’s Nando database. Some of those six offer testing in other medtech directives, and in those other directives, they remain competent.
Based on a meta-analysis of randomized trials for paclitaxel-coated devices, the FDA is concerned that they may not be safe to use, as they may be linked to mortality. Until further information is available, the FDA is recommending doctors prescribe these devices on a case-by-case basis only.
Nando has registered two new EU notified bodies as of August 2019, though the European Commission has said four notified bodies have been designated. Nando’s tardiness in updating their databases is affecting companies that need their medical products tested, especially given the huge volume of products compared to the number of notified bodies available.
Hal Barron, Chief scientific officer at GSK recently spoke about winning the hearts and minds of 10,000 R&D employees and adopting practices from acquired company, Tesaro. In Vivo covers the talk topics including how doubters are coming around amid recent successful approvals
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