Policy
Acadia Pharma’s Catherine Owen Adams has formed a group of small- to mid-cap biotechs to advocate against a ‘peanut butter blanket’ approach to drug pricing for small companies.
FEATURED STORIES
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
COVID-19 vaccines are the most-studied vaccines in history. This is partly why some data can appear so contradictory. For those and more COVID-19 stories, continue reading.
In his State of the Union Address earlier this year, President Joe Biden called for a $35 cap on insulin costs that are provided by insurance programs.
Biogen and Ionis Pharmaceuticals announced that their Phase I study of BIIB078 (IONIS-C9Rx) intended for ALS did not meet clinical endpoints, so they will discontinue the program.
Civica plans to make versions of three affordable insulins available at significantly reduced costs by 2024. You can explore the other aspirations here in this article.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will face its first big test since Aduhelm as it weighs the merits of Amylyx’s AMX0035 for ALS on Wednesday, March 30.
A federal judge in Delaware tossed out a lawsuit by Genentech, Inc., a Roche company, accusing Novartis’ Sandoz division of patent infringement.
Automation in pharmaceutical industry can make the companies target of the cyber threats emanating from Russia, China, and North Korea. It can be collateral or direct.
In honor of March 24, World TB Day, BioSpace looks at clinical trials and eradication efforts occurring today.
Pfizer has announced it received Breakthrough Therapy Designation from the FDA for its vaccine candidate intended to prevent infections caused by the respiratory syncytial virus (RSV).
The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.