ArQule's rare genetic disorder candidate nabs FDA fast-track status | FDA OKs Teva's migraine preventive | NIH initiates program for development of SCD gene therapies
September 17, 2018
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
ArQule's rare genetic disorder candidate nabs FDA fast-track status
An FDA fast-track designation was granted to ArQule's miransertib, being developed as a treatment for patients with PIK3CA-related overgrowth spectrum. ArQule has an ongoing Phase I/II trial for the indication.
eMPR (9/14) 
FDA OKs Teva's migraine preventive
The FDA approved Teva's Ajovy, or fremanezumab, an injected medication intended to prevent migraine headaches. The single-dose syringe includes 225 mg of the medication per 1.5 mL injection.
Seeking Alpha (9/14) 
NIH initiates program for development of SCD gene therapies
The NIH has launched the Cure Sickle Cell Initiative, a program that will create a national repository for data on the disease and focus on developing gene therapies for patients with sickle cell disease, with Dana-Farber Cancer Institute's Dr. Edward Benz Jr. as its executive director. Patient engagement will be key to the initiative, with patients working together with researchers in search of effective therapies for SCD and in the development and recruitment of participants for clinical trials.
Rare Disease Report (9/14) 
Medical Devices
FDA releases draft guidance, plan on 510(k) third-party reviews
Draft guidance outlining the process of determining the eligibility of certain devices for review under the 510(k) Third Party Review Program has been released by the FDA, along with a plan to reduce the number of 510(k) submissions the agency has to review after they have been reviewed by a third party. AdvaMed is still looking into the plan, although it is "pleased FDA has released the guidance," says Mark Brager, vice president of communications.
MedTech Dive (9/14) 
Biotronik's coronary stent system wins FDA approval
Biotronik has obtained approval from the FDA for its PK Papyrus covered coronary stent system for the treatment of acute coronary artery perforations via the agency's humanitarian device exemption pathway. The 5-French compatible, balloon-expandable coronary stent system, which comes in 17 sizes, is not indicated for use in candidates who are ineligible for standard percutaneous coronary intervention procedures or those with a known hypersensitivity or allergy to any compound of the stent system.
Medscape (free registration) (9/14) 
Food & Dietary Supplements
USDA, FDA to hear comments about lab-grown meat products
USDA, FDA to hear comments about lab-grown meat products
The USDA and the FDA will partner to hear public discussion about the possible hazards related to lab-grown meat products and techniques to control such hazards. Also included in the discussion will be labeling and naming issues, such as using the terms "clean meat," "lab-grown," "cell-based" or "plant-based" for lab-grown products.
Food Safety News (9/17) 
Featured Content
Sponsored content from Northwestern's Kellogg School of Management
Click here to learn more about Featured Content
HHS secretary fully backs FDA e-cigarette crackdown proposal
HHS Secretary Alex Azar expressed complete support over the FDA's proposed crackdown on e-cigarettes, which includes an order to five e-cigarette brands to submit plans on mitigating teen e-cigarette use within 60 days.
CNBC (9/14) 
Global Focus
ViiV files MAA in Europe for dolutegravir, lamivudine HIV combo
ViiV Healthcare has submitted to the European Medicines Agency a marketing authorization application for its single-tablet combo drug of Tivicay, or dolutegravir, and Epivir, or lamivudine, to treat patients with HIV-1 infection. ViiV plans to file a new drug application with the US FDA for the regimen in October.
PharmaBiz (India) (9/15) 
Hot Topics
Food and Drug Law Institute (FDLI) Highlights
Next Thursday's Live Webinar: From Approval to Coverage -- FDA and CMS Jurisdictional Lines
Next Thursday's Live Webinar: From Approval to Coverage -- FDA and CMS Jurisdictional Lines
September 27 | 2-3:30 PM ET
Panelists will provide a background and overview of the links between FDA regulatory approval and the Medicare Part A and Part B coverage process, the endpoints that both agencies consider in their decision-making process, and the ways in which the two agencies coordinate their efforts. Register now.
Patient Organizations: An Introduction to Drug Law and Regulation
Patient Organizations: An Introduction to Drug Law and Regulation
November 7-8, Washington, D.C.
Developed by patient advocates and lawyers practicing FDA law, this course highlights strategies and opportunities for collaboration with the FDA and therapy innovators throughout the drug development process. The program equips patient-focused policy professionals and advocates with a critical source of legal knowledge to enhance their interactions with the FDA. Learn more.
Learn more about FDLI:
About | Programs | Resources | Engage | Career
powered by
Food and Drug Associate
Associate Director, Corporate Counsel - Regulatory and Commercial
REGENERON - Tarrytown, NY
A life is not important except in the impact it has on other lives.
Jackie Robinson,
baseball player
Sign Up
SmartBrief offers 200+ newsletters
Learn more about the SmartBrief audience
Subscriber Tools:
Contact Us:
Jobs Contact  -
Advertising  -  Sarah Hostetler
Editor  -  Lisa Gough
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2018 SmartBrief, Inc.®
Privacy Policy (updated May 25, 2018) |  Legal Information