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In this edition of Quick Notes, we cover drug approvals for Roche’s Vabysmo for macular edema, Servier’s Tibsovo for treatment of IDH1, Coherus’ and Shanghai Junshi Biosciences’ Loqtorzi for nasopharyngeal cancer, Santhera Pharmaceuticals’ Agamree for treatment of Duchenne muscular dystrophy (DMD) and Eli Lilly’s Omvoh for treatment of ulcerative colitis. Read More
After receiving an FDA notice of insanitary conditions at the Velocity Pharma supply plant, Cardinal Health and the Harvard Drug Group are voluntarily recalling all lots of their Velocity-produced ophthalmic products. Read More
A district court has ruled against an Alvogen subsidiary challenging the FDA’s rejection of its ANDA for a “skinny version” of Silax Pharmaceuticals’ blockbuster irritable bowel syndrome drug Xifaxan (rifaximin). Read More
CBER has launched an online crowdsourcing campaign that asks stakeholders what they see as the major advances in biological product development likely to emerge in the next three to ten years, including novel products and manufacturing methods. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
The election of newly installed Speaker of the House Mike Johnson (R-La.) means the impending government shutdown on Nov. 17 almost certainly won’t occur, says Steven Grossman, executive director of the Alliance for a Stronger FDA. Read More