Archive for October 2023

Nostrum Laboratories and its CEO have struck a potential $50 million settlement with the Department of Justice (DOJ) to resolve allegations the company knowingly underpaid Medicaid rebates for its Nitrofurantoin Oral Suspension (Nitro OS) generic product. Source: Drug Industry Daily

In this edition of Quick Notes, we cover medical device clearances for GE HealthCare’s Allia IGS Pulse for cardiac imaging, Ventric Health’s Vivio system for heart failure diagnosis, the Ori by Masimo to analyze oxygen saturation and the TriLEAP anatomic plating system, a procedure-specific system designed for orthopedic clinicians. Source: Drug Industry Daily

In an agreement worth up to $600 million, Eli Lilly will acquire Beam Therapeutics’ opt-in rights to three of Verve Therapeutics’ cardiovascular disease gene-editing programs in exchange for cash, potential milestone payments and an equity investment. Source: Drug Industry Daily

Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation recently released a report focusing on how the FDA can deliver clear messaging to deliver improved understanding of the FDA and the products it regulates. Source: Drug Industry Daily

Although Medicare will now cover antiamyloid antibodies fully approved for early Alzheimer’s and the PET imaging required to qualify for them, questions remain about how coverage will shake out for other procedures that clinicians deem necessary for these treatment regimens. Source: Drug Industry Daily

Whether Vertex Pharmaceuticals’ off-target safety analysis of its investigational sickle cell gene therapy exagamglogene autotemcel (exa-cel) is sufficient or not is the issue before an FDA advisory committee on Tuesday as it considers the therapy. Source: Drug Industry Daily

In a move with ramifications for medical devicemakers, the Biden administration issued an executive order Monday targeting powerful AI systems, requiring developers to share safety test results and other critical information with the U.S. government. Source: Drug Industry Daily

Virtual listening-only sessions for the public regarding the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program began Monday — and will continue through mid-November — providing an opportunity for patients, beneficiaries and caregivers to provide input on a single drug in each session. Source: Drug Industry Daily

With the quality metrics movement resurfacing and CDER’s quality maturity model publication in the news, lately I have been giving much thought to what quality culture means and how to recognize a strong culture of quality in a pharmaceutical facility. Source: Drug Industry Daily

As the first session of the 118th Congress continues, FDAnews will track important pending legislation that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily