Opinion &amp; analysis

Data, AI And Machine Learning Are Propelling Clinical Trials Data Analysis To New Heights

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.

May 16, 2018

Data, AI And Machine Learning Are Propelling Clinical Trials Data Analysis To New Heights

Big data, AI and machine learning are no longer mere buzzwords; they have transformed clinical trial data analysis. Learn how technological advances can address both the high-touch challenges posed by patient engagement and the high-tech challenge of turning unstructured data into actionable information for clinical trials

May 16, 2018

Deals Shaping The Medical Industry, February 2019

Bristol-Myers Squibb’s acquisition of Celgene wasn’t the only big news in January. Read this brief for a comprehensive review of announcements from diagnostic, device and biopharma companies. Gain insights into both business and clinical developments, and get a peek into the in vitro diagnostics, medical devices and pharmaceuticals pipelines.

February 13, 2019

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

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.

Device Sector Braces For Investigative Stories Critical Of Industry

Rumblings of a series of reports and broadcasts from the International Consortium of Investigative Journalists (ICIJ) have gotten louder in the past few months, as the industry braces itself for the release of these sprawling investigations, believed to be highly critical of the medical devices industry.

November 21, 2018

Digital Health Technology and Regulatory Overview

$4,750.00

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

Drug Firms Fear PBM ‘Discrimination’ Over List Price Reductions, Azar Tells Hearing

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.

January 3, 2019

Drug/Device Combinations: Shock For Pharma As It Seeks Notified Body Resources Too

The delivery of drugs via medical devices being commonplace and introduction of new EU rules for these products via the MDR has the pharma industry dismayed at the uncertainty ahead and searching for notified body capacity. Medtech Insight look at the ongoing uncertainty and the state of Europe’s healthcare regulations.

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

ECHA’s Microplastic Ban Proposal Is ‘Brutally Misinformed’ – Cosmetics Europe

ECHA’s plan to ban the use of intentionally added microplastics in cosmetics is based on “a whole clutch of errors and misunderstandings,” according to Cosmetics Europe’s Director-General John Chave. Find out why the industry is worried about this ban–and why they consider it unfair. Gain insights into which solutions would satisfy the industry, and learn why biodegradable plastics–which represent a potential win-win for industry and environmental advocates–may not be viable.

February 19, 2019

Eight Talking Points from ESMO

At the 2019 congress in Barcelona from 27 September to 1 October, the European Society for Medical Oncology (ESMO) proved once again it is a match for ASCO. Scrip shares the main points of the event including Seattle Genetics victory for mid-caps.

Eight Things To Know From Novartis’ Third Quarter Call

Capture the key takeaways from Novartis’ third quarter call in this illuminating article from Scrip. Eight Things To Know From Novartis’ Third Quarter Call brings you the most important developments from the third quarter earnings call that occurred on October 18. Gain insight into the progress on new launches, regulatory developments, and more.

October 18, 2018

EMA Issues Guidance On Medical Devices That Are Integral To Pharma Products

With its first issue of guidance for the EU Medical Devices Regulation (MDR), the European Medicines Agency has focused on products that contain an “integral medical device” component, such as pre-filled syringes. Find out more about the guidance here.

March 5, 2019

EMA Set For More Staff Losses & Activity Cuts Next Year

The European Medicines Agency braces itself for a major reduction in staff and decrease in activities. The move is a reaction to Brexit and the agency’s move from London to the Netherlands. The cuts are the latest challenge presented by Brexit, as the EMA braces for an overall 30% loss of staff.

December 11, 2018

EMA To Re-Prioritize Tasks To Cope With ‘Higher Than Expected’ Staff Losses

Although original estimates put staff losses at the European Medicines Agency at about 19% due to the EMA’s relocation from London to Amsterdam, the EMA reports that these losses may actually be much higher, forcing the agency to take a hard look at its most pressing priorities moving forward.

June 8, 2018

EMA under Pressure again as Staff Losses Worsen

Higher than expected staff losses at the European Medicines Agency due to the relocations to Amsterdam are posing challenges to implement new EU legislation. While the planned move to a permanent HQ in the Dutch capital has led to a decrease in staff, the agency is having to further prioritize its business activities.

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

$100.00

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.

February 5, 2018

ESMO Preview: Five Key Oncology Battlegrounds To Watch

With Europe’s biggest cancer congress ESMO attracting large and small companies to present the latest data readouts across a broad range of tumor types, Scrip looked at the key players and the five key battlegrounds at stake.

August 3, 2019

Estee Lauder Is Revising Claims, Retesting Products After Internal Breakdown

Estée Lauder’s CEO revealed that “a small group of employees” was responsible for intentionally altering test results behind product claims. The shocking disclosure was mitigated by the fact that the problem was discovered internally. Nevertheless, stock tumbled following the announcement–but has largely recovered. Find out how the disclosure may affect Lauder moving forward, and learn how analysts reacted

May 16, 2018

EU Beats Predicted Timelines And Appoints First UK Notified Body Against MDR

Months ahead of schedule, the EU Medical Devices Regulation has succeeded in designating its first notified body. BSI UK achieved designated status much sooner than anticipated, but does that mean the road ahead for other designations will be as smooth?

January 22, 2019

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

Consultant Sarah Sorrell offers insights on the EU’s new medtech regulations that have introduced much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. Medtech interviewed her about what the requirements entail and problems with understanding them.

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

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.

EU UDI Deadlines, Documents And Planning: What Does Industry Need To Know?

Europe’s UDI (Unique Device Identification) system has a long way to go before being implemented, as the complicated process of both developing standards and adhering to those standards coninues to move forward. Examine the progress to date, with Medtech Insight.

December 18, 2018

Eudamed – A Moving Target But On Track For March 2020 Partial Go-Live

In a recent update of the European Commission’s Rolling Plan, the Commission noted that while Eudamed, the EU’s databank on medical devices, is due to go live in March of 2020, some essential portions of the database may experience a delay in availability.

March 1, 2019

European Commission Highlights Medtech Notified Bodies Giving It Cause For Concern

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.

European Commission Sheds Light On MDR/IVDR Progress In Vital Update

The European Commission has finally released some long-awaited and eagerly anticipated deadlines for Medical Device Regulations and In Vitro Device Regulations implementation measures. The deadlines shed light on progress made by the EU Commission in this area, as application dates for regulations are quickly approaching.

October 18, 2018

Farxiga Data Change Heart Failure Treatment Outlook

AstraZeneca’s Farxiga (dapagliflozin) appears set to become new standard or care in the treatment of hear failure based on results of the DAPA-HF Phase III trial present at the European Society of Cardiology Congress on 1 September. Scrip looks at Farxiga and its nearest competitors.

Father of Humira, Greg Winter, Wins 2018 Nobel Prize For Chemistry

The 2018 Nobel Prize for Chemistry was recently jointly awarded to George Winter and two other scientists for their pioneering work in the directed evolution of antibodies, research which led to the development of Humira, the world’s most successful drug.

December 9, 2018