A Delaware chancery court decreed that Johnson & Johnson Inc. owes investors in Auris Health Inc. more than $1 billion over allegations that J&J had undercut Auris products after the 2019 acquisition of Auris. The outcome highlights the hazards of acquisitions of companies that are competitive in a particular product space, but a shift in FDA policy regarding robotic surgical systems may have also played a role in this outcome.
The U.S. Centers for Medicare & Medicaid Services posted a Sept. 6 statement regarding a cyber incident involving nearly 950,000 patient records held by a Medicare administrative contractor.
Vor Biopharma Inc.’s trem-cel, a stem cell transplant designed to block the toxicity from cancer treatments, has produced some positive early stage results, including delayed relapse in patients. Phase I/IIa study data showed participants with relapsed/refractory acute myeloid leukemia benefited from trem-cel followed by treatment with Pfizer Inc.’s antibody-drug conjugate cancer fighter Mylotarg (gemtuzumab ozogamicin).
With full approval from the U.S. FDA in hand for Travere Therapeutics Inc.’s Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression, eyes turned to future prospects as well as how a revised risk evaluation and mitigation strategies (REMS) program might shake out. During a conference call hosted by Travere, Leerink analyst Joseph Schwartz wanted to know what changes might be made, and if the regulator’s decision might “actually be an entire removal” of the REMS.
In a deal that brings $60 million in cash and equity up front, plus up to $575 million in milestone payments, Shanghai-based Epimab Biotherapeutics Inc. and San Diego-based Vignette Bio Inc. entered a licensing agreement for Epimab’s BCMA-targeting T-cell engager, EMB-06, for autoimmune disease.
The FDA reported several class I recalls in the first week of September 2024, a list that includes products such as Medtronic plc’s McGrath line of laryngoscopes, some of which should be jettisoned.
Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.
On news that drove shares up by 36% on Sept. 3, San Carlos, Calif.-based Vaxcyte Inc. priced a $1.3 billion follow-on offering a day later. It is the fourth highest amount raised through a follow-on offering of shares in BioWorld’s records, as well as the second largest financing of all types for 2024, behind New York-based Pfizer Inc.’s $3.1 billion global sale of shares in March.
After receiving a complete response letter from the U.S. FDA more than three years ago and conducting another phase III trial, Iterum Therapeutics plc is preparing to make its case before an advisory committee Sept. 9 for sulopenem etzadroxil/probenecid as an oral treatment option for women with uncomplicated urinary tract infections caused by specific microorganisms.
Cytokinetics Inc. CEO Robert Blum said his firm chalked “a watershed moment” during last weekend’s congress of European Society of Cardiology (ESC) in London, where further mid- and late-stage data were disclosed with the heart drug aficamten, a myosin inhibitor. South San Francisco-based Cytokinetics rolled out six presentations, including two late breakers, with four concurrent publications in medical journals.
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