July 2023 - FDA Copilot

July 19, 2023 Artificial Intelligence FDAcop

Novartis to Invest $500M in Acquisition of Preclinical RNA Startup: Here’s the Reason

Swiss pharmaceutical giant Novartis has acquired DTx Pharma for $500 million upfront, with the potential for an additional $500 million in milestones. DTx Pharma has developed an RNA therapy that targets the liver to treat high cholesterol and has a lead drug candidate ready for Phase 1 testing in Charcot-Marie-Tooth (CMT) disease, a rare neuromuscular […]

July 18, 2023 Artificial Intelligence FDAcop

FDA Recap: July 18, 2023

The U.S. Food and Drug Administration (FDA) has provided a summary of recent news from the agency. On Monday, the FDA announced the findings from a pilot program evaluating private third-party food safety audit standards. The program aimed to assess the alignment of these standards with the requirements of the FDA Food Safety Modernization Act […]

July 18, 2023 Artificial Intelligence FDAcop

Eli Lilly Reinforces the Advantages of Early Intervention in Alzheimer’s Treatment

Pharmaceutical giant Eli Lilly has submitted its Alzheimer’s disease drug candidate, donanemab, for FDA review and has released additional clinical data supporting its application. The drug is an anti-amyloid antibody designed to target and break up plaques of amyloid beta, a protein that accumulates in the brain during the progression of Alzheimer’s. The clinical data […]

July 18, 2023 Artificial Intelligence FDAcop

Infants and Toddlers Gain Long-Lasting Protection with FDA Approved RSV Drug

Infants and young children will soon have a new measure of protection against respiratory syncytial virus (RSV), thanks to a drug developed by AstraZeneca and Sanofi. The drug, called nirsevimab and marketed as Beyfortus, was recently approved by the FDA for preventing RSV in newborns, infants, and children up to 24 months of age. This […]

July 18, 2023 Artificial Intelligence FDAcop

AR Surgical Navigation Platform, MediView XR, Secures 510(k) Clearance

MediView XR, a medical technology (medtech) company, has received clearance from the US Food and Drug Administration (FDA) for its augmented reality (AR) surgical navigation system, XR90. This platform allows healthcare providers to visualize and navigate a patient’s internal soft tissues, vascular, organ, and skeletal structures in 3D using CT images. The system also combines […]

July 17, 2023 Artificial Intelligence FDAcop

New Drug Granted FDA Approval for RSV Prevention in Infants and Young Children

The US Food and Drug Administration (FDA) has approved Beyfortus (nirsevimab-alip) as a preventive treatment for Respiratory Syncytial Virus (RSV) lower respiratory tract disease. This approval applies to neonates and infants born or entering their first RSV season, as well as children up to 24 months of age who are vulnerable to severe RSV disease […]

July 16, 2023 Artificial Intelligence FDAcop

Medicare Part D Spending in 2021: 22% Devoted to 10 Prescription Drugs, Report Finds

A new analysis by the Kaiser Family Foundation (KFF) has revealed that despite comprising only 0.3% of total covered drugs, the top 10 best-selling Medicare Part D drugs accounted for 22% of total gross Medicare drug spending in 2021. The findings offer important context for understanding the potential impact of the Medicare Drug Price Negotiation […]

July 15, 2023 Artificial Intelligence FDAcop

Making Effective Alternatives a Larger Focus in the CPAP Recall Narrative

The United States is currently facing a sleep crisis, with over one-third of American adults not getting enough sleep each night. This crisis has been worsened by the recall of millions of Continuous Positive Airway Pressure (CPAP) devices, which are commonly used to treat a serious condition called Obstructive Sleep Apnea (OSA). The recall was […]

July 15, 2023 Artificial Intelligence FDAcop

Gratitude Expressed: Life Sciences Analysis

As of FY2023, the FDA has five user fee programs that apply to its life sciences portfolio: PDUFA, MDUFA, GDUFA, BsUFA, and OMUFA. These programs require the FDA to develop new guidance documents, launch pilot programs, deploy technology systems, and hire new staff. The FDA has more than 300 tasks to complete during the authorization […]

July 15, 2023 Artificial Intelligence FDAcop

FDA Updates: July 14, 2023

The U.S. Food and Drug Administration (FDA) has provided a summary of recent news and updates from the agency. On Thursday, the FDA re-issued two temporary guidances that were originally published during the COVID-19 pandemic for certain regulatory requirements involving onsite visits abroad under the FDA Food Safety Modernization Act (FSMA). These guidances aim to […]

Month: July 2023