The FDA today warned that the recall of an infusion pump from Intera Oncology is Class I, the most serious kind. Intera recalled the Intera 3000 hepatic artery infusion pump after receiving reports from clinicians that the pumps were delivering medications (flow rate) faster than expected. If the pump delivers infusions at faster than expected flow […]
Food & Drug Administration (FDA)
First U.S. patient enrolled in MedAlliance Selution SLR drug-eluting balloon trial
MedAlliance announced today that the first U.S. patient was enrolled in a U.S. clinical trial of its novel sirolimus-eluting balloon. Geneva, Switzerland-based MedAlliance received FDA investigational device exemption (IDE) approval for its Selution SLR drug-eluting balloon in the below-the-knee procedures. One week later, the company enrolled the first patient in its multi-center FDA Selution4BTK trial in […]
FDA clears Insulet Omnipod 5 for children two years and older
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes. Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older. In June, […]
Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
Better Therapeutics (Nasdaq:BTTX) posted second-quarter quarter results today that beat the consensus forecast on Wall Street as it prepared to submit its first product for FDA review. Better Therapeutics has not yet generated revenue from the commercialization or sale of any product. The company went public through a special purpose acquisition company merger in October. […]
MedAlliance wins second FDA IDE nod for drug-coated balloon
MedAlliance announced today that received conditional FDA investigational device exemption (IDE) for its Selution SLR system. The FDA IDE nod for the novel sirolimus-eluting balloon allows MedAlliance to initiate a pivotal clinical trial for use of Selution SLR in the treatment of occlusive disease of the superficial femoral artery (SFA). Geneva, Switzerland-based MedAlliance’s second IDE […]
FDA approves first targeted infusion therapy for HER2-low breast cancer
The FDA announced today that it approved Enhertu, an IV infusion for the treatment of patients with unresectable or metastatic HER2-low breast cancer. Enhertu (fam-trastuzumab-deruxtecan-nxki) IV infusion is now the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer. The therapy received […]
Dexcom to update next-gen G7 software, delaying FDA clearance, launch timelines
The CEO of Dexcom (Nasdaq:DXCM) said today that the company’s regulatory path for the next-generation G7 has been slightly delayed. Speaking on the continuous glucose monitor (CGM) maker’s second-quarter earnings call, Dexcom Chair, President and CEO Kevin Sayer explained that the company has — based on feedback from the FDA — been tweaking the software […]
ICU Medical’s Smiths Medical has a Class I infusion pump recall
The FDA has issued a notice classifying a recall of infusion pumps from Smiths Medical as Class I, the most serious kind. Smiths Medical — which was acquired by ICU Medical in January for $2.35 billion — earlier this month issued a warning in Europe for the same reason: eight potential issues with its Medfusion […]
6 drug delivery innovations you need to know
From wearable insulin delivery devices to drug-eluting implants and everything in between, drug delivery innovation never stops. Vaccines, life-saving therapeutics, vision-correcting drugs and more are being developed and marketed for delivery with all kinds of technologies. More than a year ago, we compiled a list of eight drug delivery innovations you need to know. With […]
FDA lifts hold on Vertex’s insulin-producing cell therapy for diabetes
Vertex Pharmaceuticals (Nasdaq:VRTX) announced today that the FDA lifted the clinical hold placed on the Phase 1/2 trial of VX-880. Boston-based Vertex designed VX-880 as a stem cell-derived fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia. It could potentially restore the body’s ability […]