AdvaMed Weighs FDA Draft Guidance on HDE Program

December 28, 2018 In comments released in August 2018, AdvaMed said it disagreed with FDA’s position on what should be considered valid economic factors to determining profit eligibility, while also taking issue with a lack of clarity that randomized controlled trials are not necessary to demonstrate probable benefit.  “To demonstrate probable benefit, standard of care … Read more

Congressman charged in biotech insider trading case

December 26, 2018 Collins was a member of Innate’s board of directors and held a 17% stake in the biotech.  According to prosecutors, Collins learned from Innate’s CEO trial had failed on June 22.  Collins replied, “Wow.  Makes no sense.  How are these results even possible???” before calling his son, Cameron.  Prosecutors think Collins told … Read more

Looks who’s talking: FDA Chief Scott Gottlieb churns out statements by the dozen

December 20, 2018 The Agency (United States Food and Drug Administration/FDA) has more than doubled the number of press releases it sent out in the first half of 2018, with 126 press releases so far compared to 52 last year.  However, the most notable increase has been in Commissioner Statements.  FDA Commissioner Scott Gottlieb put … Read more

Bill Gates and others launch $30M ‘venture philanthropy’ accelerator for Alzheimer’s diagnostics

December 18, 2018 In collaboration with the Alzheimer’s Drug Discovery Foundation (ADDF), the new Diagnostics Accelerator will aim to back promising research that may not guarantee an immediate commercial return — hoping to take more risks than a traditional VC fund, while also focusing on products being developed for market, over basic science research. One … Read more

Bad Blood: The book that reads like a late-night biotech horror movie

December 13, 2018 You may already know the major plot points that have come to light over the past few years; however, that does not make the book, Bad Blood:  Secrets and Lies in a Silicon Valley Startup, any less enjoyable.  And that is credit to the engrossing writing and reporting from the Wall Street … Read more

FDA greenlights GW’s Epidiolex, the first U.S. drug made from marijuana

December 11, 2018 The Agency approved Epidiolex, or purified cannabidiol, to treat Lennox-Gastaut syndrome and Dravet syndrome in patients 2 and older.  The conditions typically begin in childhood, with frequent or prolonged seizures, and patients have a high risk of death from seizure-related causes and infections.  Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex … Read more

FDA Seeks to Overhaul 510(k) Program in Push for Modern Performance Standards

December 06, 2018 “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said in November. … Read more

International investigation links 1.7M injuries to medical devices, as FDA moves to reform its 510(k) process

December 04, 2018 The series of stories published in November 2018 across several outlets details the patchwork of international regulatory regimes overseeing the medical device industry, finding products being marketed with little to no human testing, or devices pulled from sale due to safety concerns in some countries while still being sold in others.  For … Read more