PharmTech Talk

Next Big COVID Challenge: Vaccines for Little Kids

September 21, 2021

Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.

Vaccine Booster Battle Reveals Rifts Among Regulators and Sponsors

September 20, 2021

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

Pharma Blocks Democrats’ Drug Pricing Plan

September 17, 2021

Democrats failed to gain sufficient support to advance long-debated legislation to permit Medicare drug price negotiations.

Biden Bolsters Vaccine Production in Pandemic Preparedness Plan

September 10, 2021

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

Will Price Controls Limit Drug Development? The Debate Heats Up

September 02, 2021

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

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

August 31, 2021

FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.

Pfizer Vaccine Approval Key to Boosting Vaccination Rates

August 24, 2021

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

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

August 20, 2021

The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.

Biden Highlights Drug Pricing Reforms to Advance Legislative Agenda

August 13, 2021

The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.

New Drug Approvals on Track at FDA

July 30, 2021

In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.