Opinion &amp; analysis

Abbott Launches New App To Keep Heart Failure Patients Out Of The Hospital

Abbott’s Merlin patient care network works with the CardioMEMS HF sensor system. The Merlin 10.0 update to the network allows physicians to share custom messages directly with their patients. Medtech Insight looks closer at the software and its intended benefits.

September 2, 2019

A World Without Rebates: Is FDA’s Gottlieb Offering New Vision?

Will drug rebates become illegal? U.S. FDA Commissioner Scott Gottlieb has suggested as much, and PBMs, among others, are paying close attention. Explore the implications–especially for PBMs–and find out why this is historically such a hot-button policy issue.

May 9, 2018

A Hangover Is A Disease, German Court Rules

Alcohol-related hangovers are genuine illnesses according to a recent ruling by a high-level German court. HBW looks at the case against a German wellness manufacturer for health claims made for its “anti-hangover” supplements and how deeming hangover’s a disease affects the outcome of the case.

September 2, 2019

86% Rise In GMDN Usage Heralds New Era Of Postmarket Data Analytics

The Global Medical Device Nomenclature is emblematic of the global trend toward building high-quality data sets in the public arena to derive better information about how medical devices perform. Medtech Insight covers that the new chair of the agency saying how the GMDN usage is poised to explode.

September 2, 2019

2021 J.P. Morgan Healthcare Conference Review

$4,750.00

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

2018’s Top Biopharma Deal-makers

How did biopharma shape up for 2018 in terms of mergers, acquisitions, and other business deals? Explore what transpired during last year for M&A in biopharma, when tax cuts were expected to spur major activity. In Vivo brings you a vital look back at the events of 2018.

January 14, 2019

2018 Completed Clinical Trials: Change Is The New Constant

Trialtrove’s 2018 Completed Trials: State of Industry-Sponsored Clinical Development report takes a detailed look at the record of completed trials over the calendar year, highlighting key trends by therapeutic area; the company sponsorship landscape; and trial phase, including progress of designated pivotal trials and success in meeting endpoints. This insightful annual review of clinical trials initiated by industry sponsors is a useful gauge of the diversity and innovative potential of biopharma’s investments in R&D. This year’s report reveals that, for all the consistencies in many aspects of the clinical trial landscape, changes are in the wind – particularly as companies outside the “Pharma Top 20” now contribute more completed trials than any other type of sponsor.

August 21, 2019

116th Congress Could Test Cosmetic Industry’s Commitment To Reg Reform, Preemption Viability

With Democrats taking control of the US House of Representatives in the fall of 2018, the future of proposed legislation to update cosmetics industry regulations is hazy, but likely to result in stricter regulations for products sold in the United States.

November 19, 2018

‘UKCA Mark’ To Replace CE Marking In UK Now, Or Eventually?

UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit, according to guidance issued in February. BBC said the guidance represented a plan “to replace the CE safety symbol on products in the event of a no-deal Brexit.” Is this actually the case? Find out what the UK Association of British HealthTech Industries (ABHI) had to say.

February 4, 2019

‘Something’s Going To Happen’: Former FDAer John Bailey On Cosmetics Reform Legislation

Don’t dismiss cosmetics reform efforts underway in Washington, former FDA official John Bailey warned an Independent Cosmetic Manufacturers and Distributors workshop. At the same gathering, Linda Katz, director of FDA’s Office of Cosmetics and Colors, hinted broadly at what’s ahead. Find out what she had to say and gain insights into what’s expected to be the first major regulatory/legislative overhaul in decades

May 21, 2018

‘Project Orbis’ Oncology Pilot Eventually Will Target ‘Major Impact’ Applications

The US Food and Drug Administration’s Oncology Center of Excellence will hand-select applications to enroll in its “Project Orbis” multi-national parallel review pilot program. Pink Sheet covers how the FDA will focus on applicants that are expected to have a major impact on the standard of care.

August 2, 2019

‘Implant Files’: New Device-Failure Database Benefits Companies And Savvy Consumers, But May Befuddle Others, Experts Say

The International Consortium of Investigative Journalists (ICIJ) unveiled their International Medical Devices Database (IMDD) with the aim of alerting consumers to possibly dangerous and under-regulated medical devices, but some argue that the database could confuse laypeople who attempt to use it.

December 19, 2018

‘Data Gaps’ Keep 12 Ingredients Off FDA’s Proposed OTC Sunscreen Monograph

Time to change sunscreen? Only two of 16 current sunscreen ingredients have been “generally recognized as safe and effective” (GRASE) in the FDA’s proposed final sunscreen monograph–zinc oxide and titanium dioxide. Learn which popular form of sunscreen has been singled out for additional testing and whether sunscreen powders are viable. Read what industry leaders and environmental groups have to say about the FDA’s approach.

February 21, 2019