Hidden Depths – The Impact of COVID-19 on the Pharmaceutical, Biotech and Devices Industries

The COVID-19 pandemic is shifting gears and with it, the ways in which we cope and respond. We are moving from an initial state of surprise, fear, consternation and a general lack of knowledge to an evolving understanding of consequences…

Roche: Glamorizing Breast Health Puts Breast Cancer Awareness On Display.

How do we make an age-old cause a topic worth talking about? In Ireland, women age 50 to 64 receive a mammogram every two years. But that age screening misses the quarter of younger Irish women who are diagnosed with breast cancer…

Is It Too Risky to Visit Your Doctor?

The direct health impact of COVID-19 is flashed in front of us every day in the staggering numbers of infections, hospitalizations and deaths recorded around the globe. But the indirect impact of the pandemic due to the massive disruption in…

Difficult Realities Related to Antibody Testing as a Tool in COVID-19 Recovery

In the 1980s as the AIDS epidemic took root in America, there was no test for Human Immunodeficiency Virus (HIV), the cause of Acquired Immune Deficiency Syndrome (AIDS). Rather, once developed, the HIV-antibody test was used as a surrogate marker…

Will COVID-19 Turn the Tide on Innovation for Pharma Companies?

The current COVID-19 pandemic has launched huge humanitarian waves across the globe, uniting the general public, healthcare providers, governments and industry around one common goal – to beat the virus. Even as countries begin easing the restrictive containment measures that…

Download Pharmaceutical Drug Pricing: A Look at Reputation, New Players and the Media Landscape in the United States

Roche: Understanding Multiple Sclerosis. And Fighting for Better Medicinal Access.

How can the unaffected public grasp the impact diseases like MS have on everyday life?  Blurred vision. Spatial disorientation. Extreme fatigue. These are just a few of the regular symptoms for millions of people who with live with multiple sclerosis (MS) —…

J.P. Morgan Healthcare Conference: FDA Speaks

Yesterday Commissioner Scott Gottlieb was to take the podium to address attendees at the J.P. Morgan 36th Annual Healthcare Conference being held in San Francisco.  Unfortunately, due to the current government funding impasse, he did not make it. But had…

What to Watch at the 2019 J.P. Morgan Healthcare Conference

The annual J.P. Morgan Healthcare Conference in San Francisco starts today. More casually known as “JPM,” it is the year’s must-attend event of the healthcare world. Billions of dollars are at stake. At JPM, leaders of healthcare companies and organizations…

Gottlieb Signals Depth and Scope of Changes Coming to Drug and Device Approvals in FY 19 Budget Comments

On April 17, 2018, FDA Commissioner Scott Gottlieb appeared before the U.S. House Subcommittee on Agriculture, Rural Development to discuss the Fiscal Year 2019 budget request for FDA. He began by touting the broad achievement in record approvals last year…

Healthcare Expectations for 2018

2017 was arguably one of the most monumental – and consequential – years for the healthcare industry in recent memory. And 2018 looks to be just as active across a number of areas – from business development in the biopharma…

The Rapid Pace of Change at FDA in 2018

As 2017 began, there was change in the air for FDA if for no other reason than the passage and implementation of the 21st Century Cures Act (Cures) which succinctly put, stood for the principle of enhancing and speeding innovation.…

These 3 Things Have Us Excited for the Healthcare Industry in 2018

Predicting the future is a tricky business. Still, investors, analysts, public and private companies and journalists will soon peer deeply into their crystal balls to forecast the year ahead for the healthcare industry. The forecasting is part of an annual…

From Stealthcare to Healthcare? A FleishmanHillard Policy Discussion

Since the enactment of the Affordable Care Act in 2009, there ensued a profound sense of déjà vu as Republican members of Congress tried to undermine the law through court challenges as well as through repeated attempts to vote a…

The FDA Welcomes A New Commissioner: What Will Dr. Gottlieb Do?

Mark Senak contributed to this article. Dr. Scott Gottlieb, the newly appointed commissioner of the U.S. Food and Drug Administration (FDA), has taken the lead of an agency that regulates one-fifth of the economy and oversees two of Americans’ most important…