Jiangsu Hengrui Medicine's docetaxel injection was approved by the FDA as a treatment for patients with gastric, prostatic, mammary and non-small cell lung cancer, as well as head and neck squamous cell carcinoma. The drug is expected to be launched on the US market after the approval.
Manistique, Mich.-based LaBar Poultry Farm is reportedly recalling eggs because of contamination with salmonella bacteria. The recalled eggs were packed in dozen-count cartons dated Aug. 30 and Sept. 30, 2017, which were distributed to consumers, as well as grocery stores and restaurants, in eight Michigan counties.
Research involving animals has given new hope to patients with devastating brain diseases like Parkinson's, writes Jackson Laboratory scientist Robert Burgess, but he adds that scientists are just beginning to understand the inner workings of the human brain, and far more study is needed to address the most complex and costly human diseases. Although alternatives to animal research are available and improving, there is no substitute for a living model of complex diseases, Burgess writes.
The FDA approved VBI Vaccines' investigational new drug application for its immunotherapy candidate VBI-1901, which is being developed as a treatment for patients with glioblastoma multiforme. A Phase I/IIa study of the drug is expected to be launched later this year.
The FDA sent a complete response letter to Vernalis rejecting its new-drug application for CCP-08 for the treatment of cold and cough. The company previously received a complete response letter for CCP-07 for the same indication.
Portola Pharmaceuticals' biologics license application for its factor Xa inhibitor reversal agent AndexXa, or andexanet alfa, was accepted for review by the FDA with an expected action date of Feb. 2, 2018.
The FDA gave BioStable Science & Engineering clearance to market its HAART 200 aortic annuloplasty device, which is indicated for use in congenital bicuspid aortic valve repair for aortic valve insufficiency. The device facilitates opening and closure of the aortic valve leaflet by reducing the annular diameter and making it more circular.
Camber Spine Technologies' SPIRA Open Matrix anterior lumbar interbody fusion device was granted clearance by the FDA. The device is designed for increasing fusion rates and stabilization in patients who have degenerative disc disease at up to two contiguous levels from L2 to S1.
The FDA gave Vascular Dynamics an investigational device exemption to conduct a 300-patient trial of its MobiusHD device, which stimulates baroreceptors in the carotid artery using electrodes to regulate blood pressure. The study, which is expected to be launched next month, will compare treatment of resistant hypertension using the device against a sham procedure.
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