The teamplay Cardio dashboard application was unveiled by Siemens Healthineers within the Digital Ecosystem platform. The application provides insight into the cardiology department's resources, performance and status by analyzing data from non-DICOM and DICOM sources.
The FDA granted approval to Pfizer's Ixifi, its second biosimilar of Johnson & Johnson's Remicade, for all eligible indications of Remicade, such as pediatric and adult Crohn's disease, ankylosing spondylitis, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The company's Inflectra was its first approved biosimilar of Remicade.
GeneQuine Biotherapeutics gave Flexion Therapeutics exclusive global rights to GQ-203, which is indicated for the treatment of patients with osteoarthritis of the knee. Under the deal, GeneQuine will receive $2 million upfront and is eligible to payments tied to future development and regulatory milestones plus royalties on sales.
The California Cherry Board is funding research into gene drive technology in the hopes of managing the population of the spotted-wing Drosophila fruit fly that spoils cherry fruits. The gene drive features a "selfish gene," which is inherited at a much greater rate than ordinary genes and can thus be used to spread DNA alterations that will allow scientists to control the population of the pest.
The action date for Pfizer's marketing application for Xeljanz, or tofacitinib, was moved by the FDA to June because the agency needed more time to review additional data the company submitted. The drug is being evaluated as a treatment for adult patients with moderate to severe active ulcerative colitis.
Aduro Biotech will discontinue the Phase I/II trials of CRS-207, which is indicated to treat patients with mesothelioma and ovarian cancer, because of insufficient clinical activity of the drug candidate.
Astellas UK was ruled to have breached the ABPI code for failing to include prescribing information on certain drug promotional materials, and Astellas Pharma Europe was reprimanded for using uncertified promotional materials that contained errors. Other firms found to have breached the code were Bayer for providing training materials to representatives that suggest unlicensed use, Sunovion for verbally encouraging unethical sales tactics, and A. Menarini for failing to certify/recertify and maintain its website in a timely manner.
A voluntary recall was issued by Darwin's Natural Pet Products for four production lots of Natural Selections brand Meals for Dogs because they could possibly be contaminated with salmonella. The recalled products were sold and shipped directly to consumers in September and October.
European regulators gave Medtronic CE mark approval for combined treatment with its Heli-FX EndoAnchor system and Endurant II or IIs stent graft in patients who have aortic neck lengths down to 4 mm and up to 60-degree infrarenal angulation. The company formally launched the new indication in the European Union this week.
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