June 4, 2018

It’s Time for #BIO2018!

It’s officially day one of #BIO2018 for Boston, the industry, and RareMoon. Co-founders, Chris and Sabrina, will be taking on #BIO2018 together this year to divide, conquer, and make the best of the week. This year has already been a fantastic year for RareMoon and our growth both as a company and in the intimate support we've provided to global biotech & pharma companies developing orphan medicines.
October 4, 2017

Orphan Insights, Part 3: Breakthrough Therapy Designation

A Breakthrough Therapy (BTD) is an FDA designation that was introduced in 2012 as a means to permit the FDA to grant priority review to a drug candidate under development for a serious or life-threatening disease, when clinical evidence indicates the therapy offers substantial treatment advantages over existing therapies for patients.
September 25, 2017

Orphan Insights, Part 2: The PIP

Question #1 – What are the disadvantages, if any, of filing for Orphan Drug Designation? There are really no true disadvantages in filing for orphan designation. Question #2 - When is the right time to submit a PIP? This depends on a lot of variables. In general, it can be submitted prior to initiating trials and up until initial proof-of concept trials, definitely before pivotal or confirmatory trials.