The FDA approved Regeneron’s eye drug Eylea for diabetic retinopathy, its fourth indication, reported Reuters. The approval adds further competition to Roche’s Lucentis, which was recently approved for this same condition. Eylea, which is also indicated for wet age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion, had $2.78 billion in sales last year.
Sun Pharma wants to cultivate US trust in its products. Company president Dilip Shanghvi told The Hindu Business Line his firm “will do whatever it takes” to regain regulatory approval. Sun and its subsidiary Ranbaxy are under FDA scrutiny, including an FDA ban on products from four Ranbaxy plants.
Health and Human Services is putting an additional $133 million toward reducing addiction and deaths associated with prescription opioids and heroin. The agency said in a statement Thursday that its approach will include working with healthcare professionals to address overprescribing and expanding the use of substance-abuse programs that combine medication, counseling and behavioral therapies.
Amgen’s DeCode Genetics subsidiary identified 2,000 Icelanders who are at high risk of ovarian and breast cancers but cannot tell them. MIT Technology Review reported that DeCode’s founder is talking with health authorities to see if they can override the confidentiality agreements patients signed when they agreed to share their genetic profiles. These agreements not only told patients they would be anonymous, but they also told patients they would not be informed of the results, which is what bioethicists call a right not to know.
The FDA’s 2014 proposal to do away with printed drug information for healthcare professionals is getting pushback. Regulatory Focus reported that supporters said the proposal would allow drugmakers to provide up-to-date prescribing information, which they would be able to do electronically at the labels.fda.gov website. Opponents said the website is not ready for use and are also concerned doctors will use printed patient information when talking with patients, possibly causing “workflow disruptions” and delayed care.