As the U.S. FDA struggles to meet a massive court-ordered release of documents related to its approval of the Pfizer Inc.-Biontech SE COVID-19 vaccine, it could help itself by being more proactive in publicly releasing documents related to the approval and labeling of prescription drugs, according to a U.S. regulatory expert.
The U.S. FDA has approved Sanofi SA’s treatment for cold agglutinin disease (CAD), sutimlimab, after the drug was initially rejected by the regulator for technical reasons in 2020. Paris-based Sanofi’s drug will be branded as Enjaymo.
We’ve been hearing for several years about an FDA proposal to overhaul its device regulatory framework with ISO 13485, potentially the most ambitious FDA undertaking in a quarter century. Those who don’t follow these things might find the subject terminally boring, but such a change could be a massive headache for industry, although it doesn’t have to be if the FDA can get the temperature of this regulatory porridge just right.
Biocardia Inc. received FDA breakthrough device designation for its Cardiamp cell therapy system for treatment of heart failure. The good news provided a welcome 27% boost to the share price (NASDAQ:BCDA), lifting it from $1.57 at Wednesday’s close to $2.00 by the market’s close Thursday. Extended timelines for trials associated with the pandemic have hammered the company, which has seen its stock price fall more than 60% in the last two years.
The FDA’s device center has repeatedly asserted that its goal is to ensure that patients in the U.S. will always have first access to the latest and greatest in med tech, and a new priority document resurrects that goal in principle. However, the latest strategic plan qualifies that metric as half of manufacturers of novel technologies bringing their devices to the U.S. market “first, or in parallel with other major markets” by the end of 2025.
The process of reauthorizing critical U.S. FDA user fee agreements (UFAs) for drugs, generics and biosimilars took its first step forward in Congress Feb. 3 as the House Energy & Commerce Subcommittee on Health dipped its feet into the new enhancements included in the agreements the FDA negotiated with stakeholders over the past two years.
Amid pressure to get a COVID-19 vaccine authorized for infants and toddlers sooner than later, Pfizer Inc. and Biontech SE initiated a rolling submission seeking to amend the U.S. FDA’s emergency use authorization for their mRNA vaccine to include children 6 months through 4 years of age.
The FDA has placed Logicbio Therapeutics Inc.’s phase I/II clinical trial of LB-001, an investigational AAV genome-editing therapy for treating pediatric patients with methylmalonic acidemia (MMA), on a clinical hold. So far, four patients have been dosed in the study and two have had serious adverse events related to the candidate, the company’s lead asset.
Inspan LLC has won FDA 510(k) clearance for an interspinous fixation system that can now be used to treat lumbar spinal stenosis in non-cervical spine cases of spondylolisthesis, trauma, tumor and degenerative disc disease. According to Aditya Humad, co-founder and CFO of Kicventures Group which counts Inspan among its portfolio companies, FDA clearance represents an expansion in the use of Inspan’s interspinous system into the “highly competitive space” of interventional pain management.
Applaud Medical Inc. has secured breakthrough device designation from the FDA for its acoustic enhancer technology to be used in conjunction with ureteroscopy with laser lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones. The San Francisco-based company is currently enrolling subjects in an FDA-approved pivotal trial evaluating the technology’s safety and efficacy.
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