July 03, 2018 John Maraganore, CEO of Alnylam, who has a biotech CV as long as your arm, had this to say about reports that Trump asked at a White House meeting why he should accept immigrants from “shithole countries” rather than from places like Norway: “My Mom and Dad came to this country from … Read more
June 28, 2018 People inside and outside the FDA have long discussed the publication of the CRLs the Agency sends to companies to notify them it is rejecting their applications for approval. Such transparency would enable everyone to know why the FDA rejected an application. Today, researchers, investors and other interested parties rely on the … Read more
June 26, 2018 State senators have filed the “Drug Take Back Act,” which instead of being aimed directly at drug-makers, would require chain and mail-order pharmacies to establish federally approved disposal systems for consumers, the New York Daily News reports. Those might include on-site disposal or prepaid mail-back envelopes. Republican State Sen. Kemp Hannon, one … Read more
June 21, 2018 The U.S. Food and Drug Administration (FDA) and the Department of Defense’s (DoD) Office of Health Affairs announced in January the launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel. “The FDA is fully committed to … Read more
June 19, 2018 Medical representatives are defined as professionals, rather than sales persons, who perform academic promotion and technical consultancy work, so it is “not surprising that the CFDA requires medical representatives to have certain qualifications and/or related experience,” Katherine Wang, Partner at law firm Ropes & Gray in Shanghai, tells FDAnews. Under current CFDA … Read more
June 14, 2018 Since those comments in January 2017, the United States Food and Drug Administration (FDA) has withdrawn the most rulemakings of any Department of Health and Human Services (HHS) Agency, though only a handful are related to medical products (the others are tobacco related) and it is unclear how the withdrawal of these … Read more
June 12, 2018 Traditionally, patients who receive cochlear devices to help their hearing must repeatedly return to the clinic after implantation. At these visits, audiologists adjust the settings of the implant to alter how the patient perceives sounds. The aim is to improve the patient’s ability to understand speech and cope with loud environments by … Read more
June 07, 2018 This method, however, is not necessarily the most accurate way of gauging the severity of a concussion, and better markers have been sought. In November 2017, writing in JAMA Pediatrics journal, researchers from Penn State College of Medicine have found a new marker in an unusual place: a patient’s spit. Specifically, the … Read more
June 05, 2018 Several representatives discussed the issue of expensive medicines on the House floor Wednesday, though none of the user fee programs address the issue directly. However, speeding the review of generic drugs could lower some high-priced brand name drugs and generic drugs with no competition. FDA Commissioner Scott Gottlieb praised the bill’s passage … Read more
May 31, 2018 The two-year-old DDF — which is run by venture capital firm SV Health and backed by several big biopharma companies and medical charity Alzheimer’s Research U.K. — is focused on backing groups that discover and develop disease-modifying drugs for Alzheimer’s, which despite decades of research can still only be treated with a … Read more