Use of AZ's Imfinzi expanded by FDA | Apricus gets FDA complete response letter for erectile dysfunction cream | Federal judge reverses $2.54B patent verdict for Gilead's hepatitis C drugs
February 19, 2018
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Use of AZ's Imfinzi expanded by FDA
Use of AZ's Imfinzi expanded by FDA
(Christopher Furlong/Getty Images)
AstraZeneca received approval from the FDA to use its Imfinzi, or durvalumab, in patients with unresectable stage 3 non-small cell lung cancer that has not progressed after concurrent platinum-based chemotherapy and radiation therapy. The drug was previously approved to treat certain patients with urothelial carcinoma.
Seeking Alpha (free registration) (2/17) 
Apricus gets FDA complete response letter for erectile dysfunction cream
The FDA issued a complete response letter to Apricus Biosciences regarding its marketing application for topical erectile dysfunction cream Vitaros, or alprostadil. The agency raised chemistry, manufacturing, control and safety concerns related to the 2.5% concentration of DDAIP.HCl present in the cream that the company is hoping to address in time to provide a market update early next month.
Seeking Alpha (free registration) (2/16) 
Federal judge reverses $2.54B patent verdict for Gilead's hepatitis C drugs
Federal judge reverses $2.54B patent verdict for Gilead's hepatitis C drugs
(Erik S. Lesser/Getty Images)
Gilead has won a reversal on a ruling for its patent suit with Merck regarding its hepatitis C drugs Sovaldi and Harvoni after US District Judge Leonard Stark of Delaware decided Merck's patent was invalid and didn't fulfill a requirement disclosing how the treatment can be made without undue experimentation. Stark's ruling overturned a jury verdict that had required Gilead Sciences to pay Merck a record $2.54 billion for the patent infringement.
CNBC/Reuters (2/17) 
FDA panel sets review date for Akcea, Ionis' lipid disorder drug
An FDA panel has scheduled a review May 10 of Akcea Therapeutics and Ionis Pharmaceuticals' volanesorsen, being developed as a treatment for patients with familial chylomicronemia syndrome. Aug 30 is the PDUFA date for volanesorsen.
BioCentury (2/17) 
FDA grants orphan status to Hansa's Guillain-Barré syndrome drug
The FDA granted orphan designation to Hansa Medical's IdeS, which is being developed as a treatment for patients with Guillain-Barré syndrome. The company anticipates results later this year from two ongoing studies in highly sensitized patients who do not respond to available desensitization methods.
PharmaBiz (India) (2/19) 
Pragma to launch anti-inflammatory tablets
Pragma Pharmaceuticals is expected to launch Decadron, or dexamethasone, tablets this year. The drug is used to treat inflammation in disorders of organ systems, including dermatological, gastrointestinal, neoplastic, renal and respiratory diseases; allergies; and endocrine, hematologic, neurologic, ophthalmic and rheumatic disorders.
eMPR (2/16) 
Global Focus
Roche, Genentech's multiple sclerosis therapy approved by Health Canada
Health Canada has approved Roche and Genentech's Ocrevus, or ocrelizumab, as a treatment for adult patients with early-stage primary progressive multiple sclerosis and signs of inflammatory activity. The decision was backed by results of the ORATORIO study, in which the patients who were treated with Ocrevus had a 25% lower risk of disability progression sustained for at least 24 weeks versus placebo use.
Multiple Sclerosis News Today (2/16) 
Food & Dietary Supplements
Dietary supplement maker warned by FDA over cGMP violations
San Francisco, CA-based Reishi D. International received a warning letter from the FDA because of serious violations of the Current Good Manufacturing Practice food regulations. The FDA observation noted that the firm's products were prepared, packed, or held under conditions that could result in contamination with filth or risk to health, and that the products were misbranded.
Food Safety News (2/19) 
Medical Devices
Software bug prompts recall of Roche's connected diabetes management app
A Class II recall involving Roche's Accu-Chek connected diabetes management app has been issued by the FDA following reports of a software bug in the app's Bolus Advisor calculator feature, an error that could cause unexpected changes in the unit of measurement. The company updated the app and recommended that users of the feature track active insulin and insulin bolus amounts carefully for a minimum of eight hours.
Drug Delivery Business News (2/16) 
Guardant's liquid biopsy test wins expedited access status from FDA
Guardant Health secured Expedited Access Pathway designation from the FDA for its comprehensive next-generation sequencing-based liquid biopsy test for advanced cancer called Guardant360. Using next-generation sequencing, the assay allows genomic alterations in a panel of 73 genes to be detected from cell-free DNA withdrawn from blood.
BioCentury (2/16) 
Hot Topics
Food and Drug Law Institute Highlights
Introduction to US Biologics and Biosimilars Law and Regulation
Introduction to US Biologics and Biosimilars Law and Regulation
March 20-21, Washington, DC
FDLI's intro courses provide a foundation for industry newcomers and a great overview of new topics for senior professionals. This course covers biological product regulation, the abbreviated pathway to market for biosimilar biological products, and associated intellectual property issues. Register by Feb. 22 and save. View agenda.
Careers in Food and Drug Law
Careers in Food and Drug Law
March 28, Philadelphia, Penn.
Join FDLI and Drexel University Thomas R. Kline School of Law to learn about career pathways and opportunities in the field of food and drug law over a panel discussion and networking reception. Free for students; registration required by March 23. Learn more.
Learn more about FDLI:
About | Programs | Resources | Engage | Career
powered by
Experienced FDA or NIH Attorney
Assistant Director, Educational Programs
Senior Counsel, Regulatory
ABBOTT - Abbott Park, IL
Attorney - Medical Devices, Postmarket Compliance Associate
Counsel, Advertising & Promotion
MYLAN, INC. - Washington, DC
The better part of one's life consists of his friendships.
Abraham Lincoln,
16th US president
Sign Up
SmartBrief offers 200+ newsletters
Learn more about the SmartBrief audience
Subscriber Tools:
Contact Us:
Advertising  -  Wynn Hansen
P: 202.470.1149
Jobs Contact  -
Editor  -  Lisa Gough
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2018 SmartBrief, Inc.®
Privacy policy |  Legal Information