The FDA announced it is making access to its adverse drug reaction reports easier to obtain, with open access to the public. In a press release, Taha Kass-Hout, MD, MS, chief health informatics officer at FDA, said that the information previously diffi…
Vittamed out of Carlisle, MA received European CE Mark approval for its non-invasive intracranial pressure meter and non-invasive cerebrovascular autoregulation monitor. The Vittamed 205 intracranial pressure monitor works by applying pressure to the tissue surrounding the eye using a special pressure cuff. A Doppler ultrasound transducer plac (Read more...)
A low-energy femtosecond laser enabled predictable flap creation and a low retreatment rate for hyperopic LASIK with non-custom ablation, according to a study.The prospective case series study included 800 eyes of 413 patients who underwent hyperopic L…
In an effort to validate the accuracy, consistency and reliability of diagnostic testing, the FDA has announced its intent to issue a final guidance document on the development, review and approval of companion diagnostics. The agency has also alerted Congress that it will publish a risk-based oversight framework for laboratory-developed tests, according to an agency press release. “Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” FDA commissioner Margaret A. Hamburg, MD, said in (Read more...)
(MedPage Today) — The FDA has approved the vascular endothelial growth factor inhibitor aflibercept (Eylea) for diabetic macular edema, drugmaker Regeneron announced.
Valeant Pharmaceuticals reported a total revenue of $2 billion for the second quarter of 2014, up 86% from the second quarter of 2013. The company’s net income was $126 million, or $0.37 per diluted share. Based on cash earnings per share, Valeant’s adjusted income increased by 43% from the previous year at $651 million, or $1.91 per diluted share, according to a company press release.