The Centers for Disease Control and Prevention is now investigating the salmonella outbreak caused by chicken salad from Fareway stores, saying that 65 people have been infected in Iowa, Illinois, Minnesota and Nebraska, with a new case in Texas being added to the total, and two cases in South Dakota not yet included but under investigation by the state. Chicken salad maker Triple T Specialty Meats recalled all chicken salads produced from Jan. 2 to Feb. 7 that were sold in Fareway stores in Illinois, Iowa, Minnesota, Nebraska and South Dakota from Jan. 4 to Feb. 9.
An early-stage clinical trial demonstrated that Merck's novel compound MK-8353 was shown to help block cancer cell growth in resistant melanoma and other cancers with mutations in the BRAF or RAS genes. According to the results published by researchers at the University of North Carolina Lineberger Comprehensive Cancer Center, 20% of the patients who underwent the Phase I clinical evaluation had a partial response to MK-8353.
The FDA granted orphan drug status to ContraVir Pharmaceuticals' tenofovir exalidex, which is indicated to treat pediatric patients up to age 11 with chronic hepatitis B virus infection.
Geneuro's GNBAC1 was given orphan drug status by the FDA as a treatment for patients with chronic inflammatory demyelinating polyneuropathy. Geneuro anticipates a discussion with the FDA regarding the design of a proof-of-concept midstage trial.
The FDA accepted for filing the supplemental new drug application of Allergan and Medicines360's Liletta, or levonorgestrel-releasing intrauterine system, 52 mg, seeking approval to extend the drug's duration in preventing pregnancy from up to four years to up to five years. The application is supported by additional efficacy and safety data from an ongoing late-stage trial in 1,751 women.
Eisai's Halaven, or eribulin, was not recommended by the UK's National Institute of Health and Care Excellence for National Health Service funding as a second-line treatment against locally advanced or secondary breast cancer in adults who have had a prior chemotherapy regimen because the cost regulator ruled that the drug's benefit did not meet cost-effectiveness standards. Halaven remains available through NHS funding as a third-line treatment for breast cancer patients who have had two chemotherapy regimens.
A positive trend vote that supports approval for Portola Pharmaceuticals' factor Xa inhibitor AndexXa, or andexanet alfa, was communicated by the European Medicines Agency's Committee for Medicinal Products for Human Use, but a request for additional data could prolong the regulatory body's opinion until the last quarter of 2018. The group's trend vote was negative for the company's Bevyxxa, or betrixaban, which is indicated for preventing venous thromboembolism in adult patients who have been hospitalized.
The FDA granted Access Vascular 510(k) clearance for its HydroPICC peripherally inserted central catheter, which is designed for long-term use. The device, made with the company's proprietary bulk-hydrophilic material that prevents accumulation of proteins and other biomaterials, can also withstand pressures created when fluid is pumped through it.
The FDA gave Endomag 510(k) clearance for its Magseed magnetic marker for use in marking soft tissue and for long-term implantation. The wire-free lesion localization device, which is intended to be detected using the company's Sentimag probe, is implantable into any soft tissue without restrictions on the duration of the marker's stay in the body.
NaviGate Cardiac Structures' catheter-guided Gate valved-stent bioprosthesis was used as the first orthotopic valve replacement to treat a patient with severe tricuspid regurgitation in Canada. The 79-year-old patient, who was not eligible to receive standard cardiac surgery, underwent the procedure in under 30 minutes and was released from the hospital within a few days.
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