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.

September 2, 2019

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.

September 2, 2019

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.

September 2, 2019

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