The March 5 meeting of the U.S. FDA’s Medical Imaging Drugs Advisory Committee could be the gateway to the first approved intraoperative technology for use in breast cancer that directly examines the lumpectomy cavity for residual cancer.
With two U.S. courts rejecting constitutional challenges to Medicare drug price negotiations, every company that had a drug selected for the first round of negotiations countered Medicare’s initial offer of what it considered a maximum fair price by the March 2 deadline, according to the Biden administration.
Amber Therapeutics Ltd. revealed positive data from the first-in-human investigation of its Amber-UI device, an implantable closed-loop bioelectrical therapy for urinary incontinence. Initial results highlight the safety and scalability of the Amber-UI therapy, which has the potential to meaningfully improve quality of life for patients dealing with the condition.
Neurocode USA Inc. added Alzpath Dx, a blood test for Alzheimer’s disease screening, to its lab developed tests, making it the first available for commercial use in the U.S. The move stands to make screening for the neurodegenerative disease much more accessible, as recent study results indicate Alzpath’s accuracy rivals PET scans and cerebrospinal fluid tests, the current gold standards, in detecting the signature biomarkers of the disease.
The U.S. FDA has proposed an update to an existing program for user fee reductions for companies grossing less than $100 million, although this latest update is much stingier than that. The update would provide registration fee relief for entities with revenues of $1 million or less, but only if that business is in bankruptcy proceedings, a meager bit of relief considering that registration fees in fiscal 2024 run to less than $7,700.
Shiratronics Inc. seeks patent protection for a rechargeable subcutaneous neurostimulator implant and a method for managing heat during recharge of its battery from an external device and headset.
Venture capitalists (VCs) on three different panels at Biocom California’s Global Life Science Partnering & Investor Conference gave advice to startups on a range of topics from what they’re looking for before investing to what startups should be doing to find pharma partners.
Despite what appears to be a recovering public financing market for the biopharma industry, with about $20 billion raised so far through follow-on offerings in the first two months of 2024, emerging companies remain in that precarious position between dwindling cash and their next milestone inflection points.
As Cardiff Oncology Inc. dosed the first patient in its phase II study of onvansertib (CRDF-004) in a first-line setting to treat RAS-mutated metastatic colorectal cancer (mCRC), the company also revealed positive efficacy data from its discontinued phase II of onvansertib as a second-line treatment of bevacizumab-naïve RAS-mutated mCRC.
The U.S. FDA reported Feb. 29 that data on the Hintermann series H3 total ankle system suggest a significantly higher rate of device failure than seen in premarket clinical studies, a problem that has arisen even though only five years have passed since the agency approved the device.
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