Search for an Article

 Search

Archive: July 2018

Upcoming FDA Advisory Committee Meeting for ALIS

Posted on July 12, 2018   |   
Author: Gretchen   |   
1 Comments   |   
Like 4 Likes

The U.S. Food & Drug Administration (FDA) has posted a Federal Register Notice announcing the upcoming Anti-Microbial Advisory Committee Meeting for Insmed’s inhaled liposomal amikacin. The committee will discuss new drug application (NDA) 207356, amikacin liposome inhalation suspension, sponsored by Insmed, Inc., for the proposed indication of treatment of nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen.

The meeting will take place on August 7, 2018 in the Great Room at the FDA’s White Oak campus (10903 New Hampshire Avenue, Silver Spring, MD).

If you are a patient with MAC lung disease who either did or did not participate in the Insmed clinical trial, and you wish to address the committee during the Open Public Hearing session of the meeting that day, please contact Amy or Susan at ntmmail@ntminfo.org. Please note that the deadline to register as a speaker for the FDA meeting is July 16th, so anyone who is interested should contact them as soon as possible. Compensation will be offered for travel expenses.

It would be most helpful to have two or three patients speak before the committee for 3 to 5 minutes each, addressing the severe unmet need you have as a patient, and how this drug can benefit you. If you participated in the trial, you should also discuss how it helped you, and how it would be beneficial to you to have this drug approved so they can take it.

For those unable to attend the meeting in person or who will not be speaking at the meeting, the FDA offers the opportunity to submit written comments to the docket, no later than July 24, 2018. Statements submitted are public; those submitted before the deadline are printed out and given to committee members with their briefing materials. Comments can be submitted via this link: https://www.regulations.gov/document?D=FDA-2018-N-2490-0001. Just click on the Comment Now! button.

Read More

Tags: FDA Insmed NTM
Categories: Research

COPD, Bronchiectasis and NTM Webinar Recording

Posted on July 09, 2018   |   
Author: Gretchen   |   
0 Comments   |   
Like 5 Likes

We hope you were able to join us for our June 2018 webinar with expert speaker Dr. Charles (Chuck) Daley. We are pleased to offer you the FULL RECORDING of this event. This recording is free and can be accessed at any time.

During the 60-minute webinar, Dr. Daley offered an overview of COPD, bronchiectasis and NTM, including how these conditions relate to one another as well as treatments for each condition. There were two live question and answer sessions during which members of the audience were given the opportunity to ask questions of the expert speaker.

Dr. Charles (Chuck) Daley

National Jewish Health, Denver, CO, USA

 

Read More

Tags: Awareness Bronchiectasis Treatment Bronchiectasis; NTM; Research COPD NTM Treatment
Categories: Awareness

Sign In to Participate
Or register to become a member