Medtronic plc reported its tibial neuromodulation device was implanted in the first patient with overactive bladder as part of its Titan 2 pivotal study. The device stimulates the posterior tibial nerve near the ankle to assist in regulation of bladder function. Medtronic expects to enroll 130 patients in the study.
Following another failure in amyotrophic lateral sclerosis (ALS), Biogen Inc. will discontinue its development of antisense oligonucleotide BIIB-078 with partner Ionis Pharmaceuticals Inc. The stumble is part of a mega-collaboration the two companies began 10 years ago that has also yielded a lot of success, including the blockbuster Spinraza (nusinersen).
Pavmed Inc. implanted its Portio system in three patients in a first-in-human (FIH) study of its intraosseous infusion system and successfully infused fluids in all patients without complications. The Portio system allows long-term direct access to bone marrow for delivery of fluids, medications and other substances in individuals with poor venous access, kidney dialysis or adverse reactions to anticoagulants.
Top-line interim phase I/II data from Icosavax Inc.’s virus-like particle COVID-19 vaccine fell short of company and market expectations. IVX-411, which displays the SARS-CoV-2 receptor binding domain, was found to be immunogenic and well-tolerated, but the level of immune response was lower than anticipated and inconsistent with data on Icosavax’s platform and its preclinical results.
The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study. The firms had hoped to win accelerated approval in relapsed/refractory follicular lymphoma and marginal zone lymphoma based on a single-arm phase II study called Tidal.
Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd., a company developing an oral a urate anion exchanger 1 inhibitor for the potential treatment of chronic gout, said results of a phase IIa trial show that its lead candidate, ABP-671, reduced serum uric acid levels to less than 6 mg/dL, below the clinically defined threshold of 7 mg/dL for hyperuricemia, or excess of uric acid in the blood, which leads to gout.
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint.
One of Pfizer Inc.’s last decisions of 2021 was to shell out $6.7 billion for San Diego’s Arena Pharmaceuticals Inc., a deal centered around the pipeline inflammatory disease pill etrasimod. A potential successor to Xeljanz (tofacitinib), the price New York-based Pfizer paid suggests blockbuster potential for etrasimod. Phase III results announced March 23 suggest Pfizer’s big acquisition, the fifth largest in biopharma in 2021, was money well spent.
Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection.
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