The Senate Committee on Health, Education, Labor and Pensions voted unanimously to advance the Opioid Crisis Response Act, a bipartisan bill that would allow opioids to be packaged in smaller packs for a shorter time frame, encourage development of nonaddictive painkillers and prevent illegal drug trafficking at borders, among other measures. The bill now heads to the Senate floor.
A new-drug application was filed by Astellas Pharma in Japan for generic gilteritinib as a treatment for adult patients with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia. The submission was supported by data from the ongoing late-stage ADMIRAL trial assessing the drug in adult patients with FLT3mut+ mutations who are refractory to or have relapsed after first-line AML therapy, which has co-primary endpoints of overall survival and complete remission with or without partial hematological recovery rate.
Synthetic Biologics said the FDA withdrew the breakthrough therapy designation previously granted to its Clostridium difficile drug candidate SYN-004, or ribaxamase, because of concerns associated with the study's midstage safety data. The safety concerns will be addressed in the planned Phase III trial based on discussions with the FDA, and the trial will use adopt separate co-primary endpoints to test the drug's safety and efficacy.
The FDA granted orphan drug status to Lin BioScience's LBS-007, which is being developed to treat patients with acute lymphoblastic leukemia. The company plans to launch a first-in-human early-stage study of the drug candidate in patients with drug-resistant and refractory acute leukemia in the fourth quarter.
Nutrizone expanded its previous recall of kratom supplements to include all lots sold out of abundance of caution after the FDA found salmonella bacteria during sampling. The new recall applies to all lot numbers and package sizes for 10 products sold under the Nirvanio, Pain Out and Cali names in 16 states.
One-year data from a 292-patient trial presented at the American Academy of Neurology's annual conference showed the use of Boston Scientific's Vercise deep-brain stimulation device in treating patients with advanced, levodopa-responsive Parkinson's disease demonstrated a six-hour improvement in time without dyskinesia, as well as an overall sustained improvement in quality-of-life scores. Unified Parkinson's Disease Rating Scale scores measuring motor symptoms also improved by 49.2% among the patients.
European regulators granted Shockwave Medical CE mark approval for its Shockwave S4 peripheral intravascular lithotripsy catheter, a device intended for the treatment of calcified lesions in below-the-knee arteries. The low-profile catheter minimizes arterial trauma through the local delivery of pulsatile sonic pressure waves.
Lumendi secured 510(k) clearance from the FDA for its endoscopic accessory called DiLumen C2, which is designed to ensure that an endoscope is completely positioned in the large intestine. The device creates a stabilizing therapeutic zone within the colon using two balloons and comes with two 6-mm-diameter tool channels for holding two flexible articulating hand instruments.
An offering of about 13.7 million shares of common stock was priced by Valeritas at $1.75 each in hopes of raising $24 million. Net proceeds from the offering, which will include a 30-day option for the underwriters to buy 2.1 million additional shares, will be used as working capital, as well as to support the company's general corporate functions.
The Aspire Ventures Precision Medicine Fund was created by venture capital firm Aspire Universal and has initially secured $30 million in pledges from its general partners, Aspire and health system Penn Medicine Lancaster General Health. The fund will make investments in about eight startups each year that are developing personalized medical devices and therapies.
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