Two weeks after reporting positive top-line results in first-line head and neck cancer with its lead candidate, eftilagimod alfa, in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab), Immutep Ltd. presented updated data indicating the treatment could offer a non-chemotherapy option for patients with negative PD-L1 expression. Data from cohort B of the Tacti-003 (Keynote-PNC-34) phase IIb trial, which included 31 evaluable patients with PD-L1 expression of less than 1, as measured by Combined Proportion Score, showed a 35.5% objective response rate per RECIST 1.1 assessment.
Following an advisory committee’s recommendation in May against approval, the U.S. FDA issued a complete response letter (CRL) to Novo Nordisk A/S for its once-weekly insulin icodec injection for diabetes, which is on the market as Awiqli in several other countries.
Kazia Therapeutics Ltd.'s stock shot up 248% on July 10 after the Sydney-based company reported that paxalisib showed a 3.8-month improvement in overall survival, a 33% improvement, for newly diagnosed unmethylated patients with glioblastoma (GBM) compared to the concurrent standard-of-care arm in the pivotal GBM-Agile phase II/III study.
Rgenta Therapeutics Inc. has received IND clearance by the FDA for RGT-61159, which is being developed for adenoid cystic carcinoma, colorectal cancer and other solid tumors, as well as acute myeloid leukemia.
In an action two years in the making, Dublin-based Medtronic plc withdrew a series of endotracheal tubes because of complaints of lost functionality that carries the risk of respiratory and/or cardiac arrest.
Abata Therapeutics Inc. has obtained FDA clearance for its IND application enabling initiation of a first-in-human study of ABA-101 in patients with progressive multiple sclerosis (MS). A phase I study will open later this year.
Uniqure NV shares (NASDAQ:QURE) closed July 9 at $6.67, up $2.89, or 76%, after the firm made public updated interim data including up to 24 months of follow-up findings from 29 treated patients enrolled in the ongoing U.S. and European phase I/II trials of AMT-130 for Huntington’s disease (HD).
Pulse Biosciences Inc. received U.S. FDA breakthrough device designation for its Cellfx cardiac surgery system with surgical clamp for ablation of atrial fibrillation. The Cellfx system uses nanosecond pulsed field ablation technology to deliver durable, continuous transmural ablation.
The U.S. FDA warning letter to AG Essence Inc., a maker of wound care products, raised the question of whether the the company’s Banda product line is a drug or a device, although the FDA’s device center was the issuer of the warning letter. However, the company told ioWorld that it sees its offerings as homeopathic products rather than as drugs or devices, suggesting that this product jurisdiction scrum is far from over.
Bob Califf, commissioner of the U.S. FDA, has been laser-focused on misinformation recently, and the agency reissued a 2014 draft guidance that describes an enforcement policy about third-party communications about a drug or device. The draft appears to sidestep at least one major problem with the 2014 edition, but seems to suggest that manufacturers should consider addressing misinformation about an entire class of products.
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