Federal court reinstates 2017 Medicaid DSH payment rule | AZ's acalabrutinib gains breakthrough therapy designation for CLL | FDA grants Fast Track status to Akari's nomacopan for HSCT-TMA
August 15, 2019
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Federal court reinstates 2017 Medicaid DSH payment rule
A panel of three judges from the US Court of Appeals for the District of Columbia Circuit reversed a prior court decision and reinstated a 2017 rule that requires payments from Medicare and private health insurance providers to be included in the calculation of Medicaid disproportionate share hospital reimbursement limits. Judge Karen LeCraft Henderson said the decision aligns with the objective of the Medicaid Act, and it will ensure "that DSH payments will go to hospitals that have been compensated least and are thus most in need."
Modern Healthcare (tiered subscription model) (8/14),  Becker's Hospital CFO Report (8/14) 
AZ's acalabrutinib gains breakthrough therapy designation for CLL
AstraZeneca's Calquence, or acalabrutinib, gained breakthrough therapy designation as a treatment for chronic lymphocytic leukemia. The designation was granted by the FDA as a monotherapy for adult CLL patients based on positive outcomes from two trials that showed Calquence, whether as a standalone treatment or combined with another drug, significantly extended survival without disease progression or death.
PharmaTimes online (UK) (8/14) 
FDA grants Fast Track status to Akari's nomacopan for HSCT-TMA
The FDA has designated Fast Track status to Akari Therapeutics' Coversin, or nomacopan, indicated for pediatric patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy. The company plans to launch a pivotal study next quarter.
Seeking Alpha (8/14) 
FDA OKs 3-drug combo regimen BPaL for drug-resistant tuberculosis
TB Alliance's BPaL, a three-drug combination regimen consisting of Johnson & Johnson's bedaquiline, pretomanid and linezolid, has gained FDA approval as part of a six-month treatment therapy for extensively drug-resistant tuberculosis and multidrug resistant tuberculosis. A license was granted by TB Alliance to Mylan for the production and commercialization of pretomanid as a component of specific regimens for high-income markets, as well as a non-exclusive license for low- and middle-income countries where TB is prevalent.
Reuters (8/14) 
Medical Devices
FDA clears Nexxt Spine's cervical system
The FDA has granted 510(k) clearance to Nexxt Spine's Nexxt Matrixx standalone cervical system, which is designed for use with autograft bone graft and/or allogeneic bone graft made of cancellous and/or corticocancellous bone as an adjunct to fusion for treating degenerative disc disease.
3DPrint (8/15) 
CMS delays Medicare reimbursement cut for Abiomed's Impella
The CMS will extend Medicare coverage for Abiomed's Impella ventricular support device. The agency granted Abiomed a one-year reprieve from the proposed 27% decrease in Medicare reimbursement to hospitals for use of the device.
MassDevice (Boston) (8/14) 
Food & Dietary Supplements
Cell-cultured meat: Regulatory preparations, food safety concerns
The USDA and FDA agreed in March to a joint framework for regulations regarding cell-cultured meat as interest in the sector heats up. Scaling up the technology required to make cell-cultured meat and moving it outside a sterilized lab could introduce food safety issues, according to professor Paul Mozdziak.
Food Safety Tech (8/14) 
Okanagan introduces biotech apples for food service industry use
Okanagan Specialty Fruits has introduced its biotech, non-browning Arctic apples recently during a Produce Marketing Association event. The apples have a 28-day shelf life, much longer than the standard 18- to 21-day shelf life of apples commonly found in the market. Gene silencing of the biotech fruit results in the reduction of polyphenol oxidase, the enzyme that causes browning when apples are bitten, bruised or sliced.
Capital Press Agriculture (Salem, Ore.) (8/14) 
Food and Drug Law Institute (FDLI) Highlights
View the Agenda: Food Advertising, Labeling, and Litigation Conference | Sept. 26-27, Washington, DC
View the Agenda: Food Advertising, Labeling, and Litigation Conference | Sept. 26-27, Washington, DC
Register by Aug. 29 and SAVE.
Join prominent practitioners and thought leaders from the food and dietary supplements industry for this two-day conference that will address the most pressing issues in advertising, labeling, and litigation. Learn more.
Introduction to Food Law and Regulation | Sept. 24-25, Washington, DC
Introduction to Food Law and Regulation | Sept. 24-25, Washington, DC
Register by Aug. 22 and SAVE.
Explore the essentials of food law and regulation and gain a comprehensive understanding of the various administrative agencies that impact these industries. Learn about pending regulations, food safety, food labeling, enforcement, and related issues. Register now.
Learn more about FDLI:
About | Programs | Resources | Engage | Career
powered by
Director, Legal and Regulatory Affairs
Food and Drug Associate
Director, Regulatory Affairs
Brand Counsel
NOVOCURE - Malvern, PA, US
Senior Counsel R&D Regulatory #R-79105
AMGEN INC - Thousand Oaks, CA, US
Minds are like parachutes: They only function when open.
Thomas Dewar,
Scotch whisky distiller
Sign Up
SmartBrief offers 200+ newsletters
Learn more about the SmartBrief audience
Subscriber Tools:
Contact Us:
Jobs Contact  -  jobhelp@smartbrief.com
Advertising  -  Sarah Hostetler
Editor  -  April Hollis
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2019 SmartBrief, Inc.®
Privacy Policy (updated May 25, 2018) |  Legal Information