Opinion & analysis | Page 20 of 20 | Report Store

Defying FDA: Shanghai Lab Gets Warning Letter But Won’t Relent

A Shanghai testing laboratory has been handed an FDA warning letter for refusing a GMP inspection but told the agency it rightfully did so. Pink Sheet shares the exact working of the FDA letter as well as the highly unusual response from the laboratory.

September 2, 2019

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Can Novartis Reclaim Pioneering Role In Transplantation?

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Novartis is developing a new type of immunosuppressive agent, an anti-CD40 monoclonal antibody, which might allow organ transplants to last longer in recipients, reduce pressure on transplant waiting lists, and improve long-term outcomes. In Vivo interviewed Novartis’ Head of Immunology, Hepatology and Dermatology.

September 2, 2019

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MorphoSys: A European Champion Crossing The Biopharma Rubicon

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MorphoSys, out of Munich, is one of a handful of mature European biotech companies appearing ready for greatness. In Vivo spoke with the CEO about the firm’s next generation antibody platform and why US expansion is crucial to its future.

September 2, 2019

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Roche: We’ve Abandoned Budgets And It’s Liberated Employees

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Imagine what would happen if a huge corporation abandoned the core competency of controlling its multi-million-dollar budgets and accelerating processes across R&D and commercial divisions. Would it survive? Would it actually thrive? In Vivo talks to one CEO who knows.

September 2, 2019

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The Case For Agile Innovation In Health Care

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According to a recent Bain & Company survey, while nearly 80% of health care executives said they needed to be more agile, more than half said they were not familiar with formal agile methodologies and tools and were not using them in their companies.

September 2, 2019

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GSK’s Hal Barron On R&D Progress At TwoYear Mark

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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

September 2, 2019

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Two More EU Notified Bodies But Not On Nando Yet

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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.

August 2, 2019

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FDA Announces More Actions On Drug-Coated Devices

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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.

August 2, 2019

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European Commission Highlights Medtech Notified Bodies Giving It Cause For Concern

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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.

August 2, 2019

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EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

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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.

August 2, 2019

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2021 J.P. Morgan Healthcare Conference Review

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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.

January 25, 2021

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Interventional Cardiology: Implantable Cardioverter Defibrillators

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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.

December 21, 2021

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Interventional Neurology: Cerebral Aneurysm and Arteriovenous Malformation Systems

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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.

December 16, 2021

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Digital Health Technology and Regulatory Overview

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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.

December 13, 2021

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