The May 2014 approval of Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab) brought welcome news in the form of an important mechanism of action for patients with ulcerative colitis and Crohn’s disease, but also means a burdensome course of administration – 30 minutes’ worth of infusion every six weeks, a drawback that other developers are trying to remedy. Standouts among the up-and-comers are Morphic Holding Inc., with an oral candidate that works through the same mechanism of action as Entyvio, and Protagonist Therapeutics Inc.
Inari Medical Inc. released results from its 800-person Flowtriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) registry in pulmonary embolism (PE) at the 2022 Transcatheter Cardiovascular Therapeutics conference in Boston on Sept. 18 showing that treatment of PE with its Flowtriever device provided immediate hemodynamic and symptom improvement with all-cause mortality rates under 1.0% at 30 days.
Boston Scientific Corp.’s Sentinel cerebral protection system missed its primary endpoint of reduced stroke in the PROTECTED TAVR clinical trial. The data did, however, show a significant reduction in risk of disabling stroke in the immediate days after a transcatheter aortic valve replacement (TAVR) procedure.
One of the biggest stories coming out of Transcatheter Cardiovascular Therapeutics’ annual meeting in Boston this weekend focuses on the success of Edwards Lifesciences Corp.’s freshly FDA-approved Pascal Precision transcatheter valve repair system in the CLASP IID trial, which compared it to Abbott Laboratories’ Mitraclip device in patients with degenerative mitral regurgitation (DMR) who were determined to be at prohibitive surgical risk.
Novartis AG rolled out positive phase III data Sept. 13 with Cosentyx (secukinumab), its interleukin-17A (IL-17A) inhibitor for hidradenitis suppurativa, offering more evidence for the approach taken up by a handful of biopharma firms.
Virios Therapeutics Inc. said most likely COVID-19 had a hand in the phase IIb failure of IMC-1 (famciclovir + celecoxib), a dual COX-2/COX-1 inhibitor for treating fibromyalgia. The drug failed to hit statistical significance in dampening pain severity when compared to placebo (p=0.302).
While no one can tell the future, a panel of autoantibodies developed by researchers at New York University Grossman School of Medicine and Perlmutter Cancer Center may give physicians a much better idea about how a patient will respond to immunotherapy. That could help improve therapy selection by accurately predicting whether a patient’s cancer will recur following immunotherapy or they will experience autoimmune side effects as a result of treatment, a study published in Clinical Cancer Research on Sept. 15 found.
A prespecified interim analysis revealed that Astrazeneca plc’s oral factor D inhibitor danicopan met the primary endpoint of a phase III trial as an add-on therapy for patients with paroxysmal nocturnal hemoglobinuria (PNH) who were also taking a C5 inhibitor, but who still experienced extravascular hemolysis.
Bearish investors dwelling on a single grade 4 liver enzyme elevation seemed to be the cause for Intellia Therapeutics Inc.’s sinking stock Sept. 16, despite the company reporting impressive, though early stage, data for its leading systemically administered CRISPR candidates targeting hereditary angioedema (HAE) and amyloid transthyretin (ATTR) amyloidosis.
After a midstage trial showed no benefit from adding ELX-02 (exaluren) to Kalydeco (ivacaftor, Vertex Pharmaceuticals Inc.) for certain cystic fibrosis (CF) patients, Eloxx Pharmaceuticals Inc. said it will discuss next steps for the program, its lead candidate, with the trial's sponsor, the CF Foundation. A proof-of-concept trial for EXL-02 in the rare kidney disease Alport syndrome will start later this year, the company said.
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