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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
Biotech products comprise nearly one-third of the $1.5 trillion global pharmaceutical market this year, according to a new Tufts Center for the Study of Drug Development (CSDD) study, with sales growing at five times the rate of traditional pharmaceuticals and hitting $466.3 billion in 2022. Read More
Vertex doesn’t need to do any more safety studies to identify potential off-target effects for exa-cel (exagamglogene autotemcel), its investigational gene-editing therapy designed to cure sickle cell disease, an FDA advisory committee decided. Read More
Despite missing its pivotal phase 3 primary efficacy endpoint, Sarepta is sailing confidently into a supplemental application to remove the age limitation on Elevidys (delandistrogene moxeparvovec-rokl), its gene therapy for children with Duchenne muscular dystrophy (DMD). 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
Upcoming events in the coming weeks include three FDA advisory committee meetings as well as the 18th Annual Inspections vSummit from FDAnews, a WCG company, and webinars on how to use UDI and UDI Data, the importance of selecting the right partner for independent expert committees, choosing the right IRB review partner and medical device cybersecurity. Read More
A new FDA guidance set to take effect immediately extends the agency’s COVID-era policies requiring supplementary submissions for certain modifications to a device approved under the premarket approval (PMA) or humanitarian device exemption (HDE) pathways. 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
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. Read More
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. 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