Impax's generic heart failure drug gets tentative FDA nod | Court dismisses Amgen's infringement complaint against Coherus | FDA OKs Zydus' schizophrenia therapy
December 11, 2017
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Impax's generic heart failure drug gets tentative FDA nod
Impax Laboratories' generic version of GlaxoSmithKline's heart failure drug Coreg CR, or carvedilol phosphate, was granted tentative FDA approval. Impax's marketing application is eligible for FDA final approval upon expiration of GSK's patent protection on May 7, 2018.
Seeking Alpha (free registration) (12/8) 
Court dismisses Amgen's infringement complaint against Coherus
A magistrate judge recommended the US District Court for the District of Delaware dismiss Amgen's patent infringement lawsuit against Coherus Biosciences. Amgen filed the suit after Coherus' submission of a marketing application for a biosimilar of Neulasta, or pegfilgrastim.
Seeking Alpha (free registration) (12/8) 
FDA OKs Zydus' schizophrenia therapy
The FDA approved Zydus' Clozapine tablets USP, intended for the treatment of patients with schizophrenia. The company will produce the drug at its facility in Ahmedabad, India.
Reuters (12/8) 
FDA OKs pathway to SteadyMed's Trevyent NDA resubmission
The FDA approved the pathway to resubmission of SteadyMed's new-drug application for Trevyent, which requires that SteadyMed only repeat the in vitro design verification testing on the final product. The company anticipates the filing and acceptance of the drug before the end of next year.
Reuters (12/8) 
Global Focus
AbbVie's hepatitis C drug, Novartis' lung cancer therapy backed by NICE
The National Institute for Health and Care Excellence recommended the use of Novartis' Zykadia, or ceritinib, as a treatment for adult patients with untreated ALK-positive non-small cell lung cancer at a confidential discounted price agreed upon with the company. The institute also recommended the use of Maviret, or glecaprevir-pibrentasvir, in adult patients with chronic hepatitis C.
PharmaTimes (U.K.) (12/8) 
Kyowa reports positive result of late-stage study of Sezary syndrome drug
Kyowa Hakko Kirin's Poteligeo, or mogamulizumab, achieved the primary endpoint of a late-stage study, in which it led to a median progression-free survival of 7.7 months compared with 3.1 months for Zolinza, or vorinostat, in patients with Sezary syndrome.
BioCentury (12/10) 
Food & Dietary Supplements
Seafood, juice importer, dairy, airline caterer get FDA warning
The FDA issued warning letters to seafood and juice importer Bedessee Imports, dairy Hilgenkamp Farm and airline caterer Tufo's To Go over violations of federal food safety rules. The agency observed multiple violations among the companies, including violations on Seafood Hazard Analysis and Critical Control Point regulation, the Juice Hazard Analysis and Critical Control Point regulation and the Current Good Manufacturing Practice regulation for foods.
Food Safety News (12/11) 
Medical Devices
Study shows positive results for NxStage's remote patient management system
A study in Hemodialysis International found the use of NxStage Medical's Nx2me Connected Health remote patient management system in-home hemodialysis demonstrated a 29% reduction in technique failure or conversion to in-center hemodialysis. The findings, based on data from 606 patients, showed use of the system within three months after initiation of home hemodialysis was associated with a 34% reduction in technique failure.
MassDevice (Boston) (12/8) 
Congress' inaction on medical device tax frustrates industry
The medical device industry has expressed frustration about Congress' inaction to repeal the medical device tax despite lawmakers saying "the right thing" during their meetings, said AdvaMed President and CEO Scott Whitaker after the House and the Senate failed to include the tax when they resolved plans on tax cuts. Whitaker said he believes a last-minute plan would be devised by Congress to prevent the tax from being implemented and said the industry group will go to congressional districts to talk about the tax's impact if the issue bleeds into 2018.
Star Tribune (Minneapolis-St. Paul, Minn.) (tiered subscription model) (12/10) 
Omnia Medical VBR wins FDA clearance
The Omnia Medical VBR, a vertebral body replacement system developed by Omnia Medical, Invibio Biomaterial Solutions and JALEX Medical, was granted clearance by the FDA. The single-use system, which comes with PEEK-OPTIMA HA Enhanced polymer, is intended for replacing damaged, unstable or collapsed vertebral body in the thoracolumbar spine.
Becker's Spine Review (12/8) 
Hot Topics
Food and Drug Law Institute Highlights
FDLI 2018 Annual Conference: Exploring Advanced Topics in Food and Drug Law
FDLI 2018 Annual Conference: Exploring Advanced Topics in Food and Drug Law
May 3-4 | Washington, D.C.
The premier conference for the food and drug law community, the FDLI Annual Conference addresses every product category regulated by the FDA. The two-day event will bring together industry experts to cover the latest legal, regulatory and policy issues. Learn more.
Available online: The Food and Drug Law Journal, Volume 72, Number 4
Available online: The Food and Drug Law Journal, Volume 72, Number 4
Catch up on current topics with The Food and Drug Law Journal, a peer-reviewed quarterly that FDLI publishes in partnership with the Georgetown University Law Center and the O'Neill Institute for National & Global Health Law. Read the full articles.
powered by
Associate Manager Quality Compliance
ALTRIA - Richmond, VA
There is no foreign land; it is the traveler only that is foreign.
Robert Louis Stevenson,
Learn more about FDLI:
About | Programs | Resources | Engage | Career
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
© 1999-2017 SmartBrief, Inc.®
Privacy policy |  Legal Information