By Julian Urrutia Gilead Sciences has developed a new drug (Sovaldi) that cures hepatitis C. This is a huge deal: about 150 million people world wide are chronically infected with the hepatitis C virus (HCV); according to the CDC 60-70% of people with chronic HCV will go on to develop chronic liver disease, 5-20% will develop…
Dallas Buyers Club: Free Film Screening and Panel Discussion April 16, 2014 6:00 PM Wasserstein Hall 1010, 1585 Massachusetts Ave. Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care…
By Kate Greenwood Cross-Posted at Health Reform Watch As Kurt Karst reported at FDA Law Blog, here, drug maker Zogenix has filed a Motion for Temporary Restraining Order and Preliminary Injunction challenging Massachusetts’ decision to “prohibit the prescribing and dispensing” of the company’s extended-release hydrocodone capsule, Zohydro ER. At a hearing on Tuesday, Judge Rya Zobel…
By Matthew L Baum I have written previously on this blog about morally modifying technologies (here and here), which by definition work no better than existing technologies but enable the side-stepping of a moral tension associated with the first technology. Generic pharmaceuticals are a particularly well-known and widely endorsed form of morally modifying technology: they have…
By Michael Young In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and review of any drug “intended, alone or in combination with 1 or more other drugs,…
By Timo Minssen Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard. The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston. I…
By Ryan Abbott Video: Here. On January 13, 2014 the Southwestern Law School Federalist Society student chapter hosted a debate about the FDA’s role in regulating off-label drug use featuring Professor Richard Epstein, the Laurence A. Tisch Professor of Law at NYU and the Kirsten Bedford Senior Fellow at the Hoover Institution, and Ryan Abbott,…
By Arthur Caplan Art Caplan has a new opinion piece up at MSNBC on the #SaveJosh social campaign that is seeking to get a young cancer patient access to an experimental drug under compassionate use policies. From the article: If Josh were 67 instead of 7, he would already be out of luck. Those who…
By Kate Greenwood Cross-Posted at Heath Reform Watch Lately it seems that each passing day brings another article about the cost of orphan drugs. Earlier this week at FiercePharma, Tracy Staton reported that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has asked Alexion Pharmaceuticals to justify the price of its drug…
In “The “Problem” with the European Problem/Solution Approach to Inventive Step,” Harold C. Wegner reviews Petrie-Flom Visiting Scholar Timo Minssen‘s doctoral thesis. From the review: Patent applicants seeking to gain global patent protection beyond their home country borders need a better comparative knowledge of key elements of the patent laws of the several countries. Professor…
