Author Archives: Janet Tice

FDA Promoting Generic Competition

By | January 11, 2018

[The following post has been excerpted from comments by FDA Commissioner Scott Gottlieb as published by the FDA on its website on January 03, 2018.] The FDA has announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming… Read More »

FDA and Spark Therapeutics Make History with Gene Therapy Approval

By | December 21, 2017

The FDA has approved Luxturna, an innovative one-time gene therapy treatment from Spark Therapeutics used to improve vision in patients with vision loss due to inherited retinal diseases (IRD). As the first adeno-associated viral (AAV) vector product approved for clinical use in the United States, Luxturna represents a historic landmark, not only in the field… Read More »

FDA Approves First Short-Acting “Follow-On” Insulin Product

By | December 14, 2017

The FDA has granted approval to Sanofi-Aventis U.S. for Admelog, a short-acting insulin product. Admelog is the first short-acting insulin approved as a “follow-on” product and was submitted through the agency’s 505(b)(2) abbreviated approval pathway. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is… Read More »

Student Members Earn Chapter Scholarships

By | July 26, 2017

The Chapter is proud to award $12,500 in scholarships to the following winners of the June 2017 round of the Joel Goldenberg Memorial Scholarship Program: Adam Blackwell, UMass Amherst John de la Parra, Northeastern University Michael Doane, UMass Lowell Chelsea Fox, University of Rhode Island Jamie Freud, Worcester Polytechnic Institute Daniel Kallin, UMass Amherst Aislinn… Read More »

FDA Update: Agency Takes Action to Eliminate Orphan Drug Backlog

By | June 29, 2017

The FDA has unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to… Read More »

FDA Update: Agency Takes New Steps to Encourage Development of Generics

By | June 29, 2017

The FDA is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where… Read More »

Remembering Biotech Industry Pioneer Henri Termeer

By | June 1, 2017

Henri Termeer, one of the founding fathers of the biotech industry, died recently after collapsing in his Marblehead home. He led Genzyme from 1983 to 2011, the year Sanofi bought the company for more than $20 billion, and is credited with pioneering the much-imitated business model that would generate hundreds of medicines targeting rare diseases.… Read More »