Acutus Medical Inc. scored big with regulators in recent weeks. The company, which focuses on devices to diagnose and treat cardiac arrhythmias, received FDA approval to launch an investigational device exemption clinical trial for its Acqblate Force sensing ablation catheter and system in atrial fibrillation just two weeks after gaining CE mark approval for a broad suite of electrophysiology products.
The controversy over the use of paclitaxel in devices for the peripheral vasculature has taken a significant bite out of sales, but a new study serves to help reverse the narrative regarding mortality. According to a study of more than 168,000 Medicare patients, stents and angioplasty balloons coated with paclitaxel (PTX) were non-inferior to non-coated devices for mortality out to nearly three years, a finding that may encourage clinicians to return to normal utilization patterns and thus help to restore sales volumes.
There’s been a mixed bag of data from Astrazeneca plc’s efforts against COVID-19, after data suggested Pfizer Inc.’s rival vaccine is more effective against the Delta variant and the failure of a trial involving its long-acting antibody therapy.
Biogen Inc. has announced contrasting results from phase III trials of therapies for a rare eye disease and depression, following last week’s controversial FDA approval of Alzheimer’s drug Aduhelm. The Cambridge, Mass.-based firm said a phase III gene therapy study in the rare retinal disease choroideremia missed its primary and secondary endpoints, although the news was better from a potential therapy for major depressive disorder.
Veracyte Inc. reported new data showing its Decipher Prostate genomic classifier can help to identify patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) who are more likely to benefit from treatment with Erleada (apalutamide) in addition to androgen-deprivation therapy (ADT). The study is the first to demonstrate Decipher Prostate’s prognostic utility in men with locally advanced prostate cancer.
LONDON – The Delta variant of SARS-CoV-2 originally identified in India is causing more serious illness and reducing the effectiveness of vaccines compared to the Alpha (Kent) variant, according to a nationwide study covering Scotland’s whole population of 5.4 million.
Johnson & Johnson’s Janssen Cilag Ltd. pharma unit has phase III data from its project combining the oral blood cancer drug Imbruvica (ibrutinib) with its blockbuster rival, Venclexta (venetoclax), in chronic lymphocytic leukemia (CLL), which could give it an edge over competitors in the space.
Rapt Therapeutics Inc. CEO Brian Wong said RPT-193 monotherapy in atopic dermatitis (AD) “looks really promising, but there’s still quite a bit to learn” about the small molecule, designed to inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4. Investors saw enough to push the shares of South San Francisco-based Rapt up 115.5%, or $21.45, to close at $40.02, after trading as high as $41.99 during the day.
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
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