Regulatory Open Forum

Hope everyone had a nice weekend! 

Today I wanted to share with you that Collategene just became the first gene therapy drug to win insurance coverage in Japan. 

Six months after Collategene became the first gene therapeutic drug cleared for use in Japan, the country's health insurance system announced in September 2019 it would be placed on the list of pharmaceuticals approved for coverage. The drug, which introduces genes that create proteins to a patient's body, is projected to be used to treat clogged arteries, among other conditions. The decision to make the drug eligible for government-guaranteed insurance coverage is expected to reduce the price of the drug for patients in Japan by as much as 70%.


------------------------------
Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.com
contact@pacificbridgemedical.com
------------------------------

This message was posted by a user wishing to remain anonymous

This is great news Ames! What would be the process to get an FDA-cleared medical device to Japan for use in a gene therapy drug trial?
Original Message:
Sent: 21-Oct-2019 16:04
From: Ames Gross
Subject: First gene therapy drug wins insurance coverage in Japan

Hope everyone had a nice weekend!

Today I wanted to share with you that Collategene just became the first gene therapy drug to win insurance coverage in Japan.

Six months after Collategene became the first gene therapeutic drug cleared for use in Japan, the country's health insurance system announced in September 2019 it would be placed on the list of pharmaceuticals approved for coverage. The drug, which introduces genes that create proteins to a patient's body, is projected to be used to treat clogged arteries, among other conditions. The decision to make the drug eligible for government-guaranteed insurance coverage is expected to reduce the price of the drug for patients in Japan by as much as 70%.


------------------------------
Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.com
contact@pacificbridgemedical.com
------------------------------

THX…to get your device into Japan for a drug trial the drug CRO should be able to help with this….thx,ames

 

------------------------------
Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.com
contact@pacificbridgemedical.com
------------------------------

Original Message:
Sent: 21-Oct-2019 16:55
From: Anonymous Member
Subject: First gene therapy drug wins insurance coverage in Japan

This message was posted by a user wishing to remain anonymous

This is great news Ames! What would be the process to get an FDA-cleared medical device to Japan for use in a gene therapy drug trial?
Original Message:
Sent: 21-Oct-2019 16:04
From: Ames Gross
Subject: First gene therapy drug wins insurance coverage in Japan

Hope everyone had a nice weekend!

Today I wanted to share with you that Collategene just became the first gene therapy drug to win insurance coverage in Japan.

Six months after Collategene became the first gene therapeutic drug cleared for use in Japan, the country's health insurance system announced in September 2019 it would be placed on the list of pharmaceuticals approved for coverage. The drug, which introduces genes that create proteins to a patient's body, is projected to be used to treat clogged arteries, among other conditions. The decision to make the drug eligible for government-guaranteed insurance coverage is expected to reduce the price of the drug for patients in Japan by as much as 70%.


------------------------------
Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.com
contact@pacificbridgemedical.com
------------------------------