A minority stake in Glycotope and an exclusive global license for an intellectual property that covers its recombinant technology have been obtained by Octapharma in an agreement worth more than $90 million. Under the terms of the deal, Glycotope will receive an upfront payment of $90 million plus undisclosed milestone fees, sales royalties and revenues, while Octapharma will get access to Glycotope's investigational human blood coagulation factor pipeline.
The FDA has cleared Carestream Health's Vue Motion viewer to be used to read ECG exams on mobile devices and desktop computers. The viewer, which can be used for past and current readings of ECGs, has gain and speed adjustment tools, a pan function and a zoom option.
Possible contamination with listeria prompted Whole Foods Market to recall Papillon Organic Roquefort Cheese items. Affected products were distributed to stores across the country in clear plastic wrap and have scale labels that start with "PLU 029536."
An investigational new drug application has been filed with the FDA by Nektar Therapeutics for its solid tumor drug NKTR-214. The firm expects to start a Phase I/II trial by the end of 2015 that will evaluate the drug as a monotherapy and in combination with a checkpoint inhibitor as a treatment for patients with solid tumor malignancies.
The VitalBeam radiotherapy platform, developed by Varian Medical Systems, has obtained the CE mark in Europe and 510(k) clearance from the FDA. The system, intended for high-throughput treatment facilities, includes features from the company's TrueBeam technology.
The Tyrx, an absorbable, antibacterial envelope developed by Medtronic for use with deep-brain stimulation systems, has received 510(k) clearance from the FDA and is being launched in the US. The envelope elutes the antimicrobial drugs rifampin and minocycline for seven days.
The Supria 16-slice CT technology from Hitachi Medical Systems America has obtained clearance from the FDA. The device, which can accommodate various patient sizes, is designed to provide lower-dose radiation exposure.
Great Basin Scientific has submitted a 510(k) clearance application to the FDA for its Shiga Toxin Direct Test. The molecular diagnostic test provides results in less than three minutes for Shiga toxin-producing E.coli and the serotype O157 using stool samples.
Eli Lilly & Co.'s LY2835219, or abemaciclib, has received breakthrough therapy status from the FDA for use in refractory hormone-receptor-positive advanced breast cancer patients who have been heavily pretreated. The designation was backed by data from a small study showing the drug yielded a 33.3% objective response rate and median progression-free survival of 8.8 months in HR-positive breast cancer patients.
Treatment-naive pediatric patients with chronic hepatitis B who received lamivudine monotherapy or interferon-alpha monotherapy had treatment responses comparable to patients who were treated with a combination of the two drugs. The 403-patient study also found that spontaneous seroconversion, which was more common among older children, occurred in 31.2% of patients. The findings were presented at the IDWeek 2015 meeting.
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