Drugs

Thermosome Gets Orphan Status on Sarcoma Drug

FDA has granted Thermosome an orphan drug designation for THE001 and its use in treating soft tissue sarcomas (STS). “In its decision, the FDA recognized that Thermosome's innovative doxorubicin-encapsulating thermosensitive liposomes may be clinically superior to currently approved non-liposomal forms of doxorubicin due to its potential for increased efficacy,” the company says. The designation is based on preclinical and early clinical data from a Phase 1 study, it adds.

THE001 uses a unique formulation of doxorubicin combined with deep regional radiofrequency hyperthermia to target doxorubicin-sensitive tumors like soft tissue sarcomas, according to the company. It delivers up to 15-fold higher local drug concentration in the tumor to overcome drug resistance.

Currently, Thermosome says the drug is being investigated in a phase 1 clinical trial, with the primary end point of maximum tolerated dose, and secondary end points include adverse events (AEs), serious AEs, laboratory abnormalities, electrocardiogram abnormalities, echocardiogram abnormalities, renal toxicity, and pharmacokinetics.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome