Articles

Nicole Richie, Global Head Health Equity and Population Science at Genentech/Roche, discusses a renewed strategy in big pharma to incorporate diversity inclusion in clinical trials.

Clinical Trial Diversity Inclusion is Becoming a Socially Responsible Initiative

FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics.

FDA Moves to Advance Innovative Excipients

White House officials recently announced a nearly $3 billion program to ramp up production of vaccines and their components to better serve patients in the U.S. and globally.

Biden Bolsters Vaccine Production in Pandemic Preparedness Plan

A report from the bipartisan Congressional Budget Office analyzes how drug pricing policies could reduce the number of new therapies coming to market.

Will Price Controls Limit Drug Development? The Debate Heats Up. 

FDA has revealed its plan for revising and renewing its fee program for drugs and biologics.

FDA, Industry Map New R&D Initiatives under Next User Fee Program

Terence Rooney, VP of Clinical Development at Janssen, talks through the journey of how Janssen changed during the pandemic, and what the future holds.

Post-Pandemic World Forces Change in Big Pharma

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Promises of "more equitable access for those with severe diseases," "decision-making flexibility where it counts," and more in a bid to win post-Brexit business.

NICE Consults On Its New Assessment Scheme Amid A Blizzard Of Spin

The first COVID-19 vaccine, Comirnaty, has received FDA approval. How will vaccination rates be effected? 

Pfizer Vaccine Approval Key to Boosting Vaccination Rates

While biopharma companies will pay more than $3 million to file an NDA or BLA application during fiscal year 2022, new fees for generic drugs will see modest or no increases and those for biosimilars may drop or hold even.

FDA User Fees To Rise–and Fall–as New Fee Agreements Move Forward

The White House is looking to pay for some of its prime social and health initiatives by reducing outlays for prescription drugs, according to an announcement by President Biden.

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