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.
Altimmune Inc. has come under scrutiny from investors after weight loss data from a phase Ib trial of its nonalcoholic fatty liver disease drug, pemvidutide, sent its shares on a roller coaster ride.
Top-line phase III results showing Hutchmed Ltd.’s targeted therapy fruquintinib reduced the risks of death and disease progression by 34% and 68%, respectively, for patients with metastatic colorectal cancer could “lay a solid foundation for Hutchmed to initiate discussions with regulatory authorities worldwide,” a spokesperson of Hutchmed, told BioWorld.
Rubius Therapeutics Inc. is taking a giant step back so that it can attempt taking a few steps forward. The company said it’s restructuring to focus on taking its Rubius Erythrocyte Design (RED) cell therapeutics platform from what it considers a good thing and turn it into a better one. Rubius engineers red blood cells to become cancer fighters but a lack of progress and the lure of similar but new technology could lead to bigger and better results.
RSS
