Early feasibility studies for cardiology devices were a massive problem for the FDA and industry in times gone by, a problem that was believed to drive device flight from the U.S. That problem has been largely solved, according to the FDA’s Andrew Farb, but Farb noted that neurological devices are the next target for improved early feasibility study (EFS) development in the U.S., which suggests that the path to pivotal studies for devices in this space will soon be much less cumbersome.
Medtronic plc is ceasing global sales and distribution of its Heartware ventricular assist device (HVAD) due to safety concerns. The news sent Medtronic shares down about 1% in early morning trading. The Dublin-based company said it made the decision to stop selling the HVAD left ventricular assist device after clinical comparisons found a higher frequency of neurological adverse events, including stroke and mortality, with its heart pump device vs. other circulatory support systems.
Preparing for the full implementation of the 2013 Drug Supply Chain Security Act (DSCSA), the FDA finalized two guidances June 3 and released two draft guidances to help supply chain partners comply with the law’s requirements, including those for enhanced drug distribution security at the package level that go into effect in November 2023.
Edwards Lifesciences Corp. has won the FDA’s nod for its Acumen hypotension prediction index (HPI) software with the Acumen IQ finger cuff. Prior to receiving this 510(k) clearance, the low blood pressure prediction software was only available for patients using an invasive arterial line. The Acumen HPI software uses data gleaned from the Acumen IQ cuff, along with machine learning, to alert clinicians if a patient is at risk of hypotension, drops in pumping pressure that reduce the flow of oxygenated blood and nutrients to the body’s vital organs.
Novartis AG is closing in on a label expansion for its blockbuster inflammatory disease drug, Cosentyx (secukinumab), after announcing supportive phase III results in children with two subtypes of juvenile idiopathic arthritis (JIA).
Following a priority review, Scynexis Inc.'s oral antifungal, Brexafemme (ibrexafungerp), has won FDA approval for the treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. The one-day oral treatment, which kills a broad range of Candida species, including azole-resistant strains, represents the first approved drug in a new antifungal class in more than 20 years as well as being Scynexis’ first commercial product.
Acting FDA commissioner Janet Woodcock appeared at the annual forum held by the Medical Device Innovation Consortium (MDIC) and noted that real-world evidence (RWE) has tremendous potential in regulatory decision making. However, she cautioned that while “the future is very bright” for RWE, “it’s going to take longer than some of the enthusiasts might have thought” to maximize this source of data in product reviews.
Alkermes plc worked its way through a complete response letter (CRL) issued in late 2020 as the FDA has approved Lybalvi (olanzapine and samidorphan) for treating adults with schizophrenia and bipolar I disorder. The once-daily, oral antipsychotic treatment, the company’s first, is for maintenance monotherapy or acute treatment of manic or mixed episodes and as a monotherapy or adjunct to lithium or valproate. The therapy had a June 1 PDUFA date.
Little more than two months after inking a $2 billion-plus commercialization deal with Swiss oncology specialist Helsinn Group around the fibroblast growth factor receptor (FGFR) inhibitor infigratinib, Bridgebio Pharma Inc.'s subsidiary, QED Therapeutics Inc., has won accelerated FDA approval for the therapy, to be marketed as Truseltiq. Approval for the oral medicine covers the treatment of patients with previously treated locally advanced chemotherapy-resistant bile duct cancer (cholangiocarcinoma) harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test.
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