Tipping Point Network, Inc.

04/22/2020

A great snapshot of clinical trials of drugs repurposed for COVID-19 that are expected to be completed by June 30, 2020.

International biotechnology industry analysis, data and networking focused on translation, research, development, regulation, commercialization, partnering and funding.

04/22/2020

With all the talk of repurposing approved drugs to help in the fight against COVID-19, I thought this 2016 article highlighting the promise of repurposing approved (and failed drugs) as well as the roadblocks to studying these drugs might be of interest. Did you know that Vi**ra was developed for erectile dysfunction after erections were observed as a side effect of the drug being tested for cardiovascular disease?

An entire industry has sprung up around resurrecting failed drugs and recycling existing compounds for novel indications.

04/15/2020

ClinRegs - a great single resource for country-specific clinical research regulations including Guidances regarding COVID-19 impact on clinical trials. https://clinregs.niaid.nih.gov/

04/04/2020

Keep up to date with the FDA's recommendations and policies during the COVID-19 pandemic.

FDA is providing recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts.

01/27/2017

Check out the 2017 Agenda for publishing new and revised FDA Guidances.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417290.pdf

"FDA rules have great impact on the nation’s health, industries and economy. These rules are not created by chance or in a vacuum. They are formed with the public’s help.
By law, anyone can participate in the rule-making process by commenting in writing. FDA routinely allows plenty of time for public input (typically 60 days) and carefully considers these comments when it draws up a final rule. The public can submit comments about the proposed regulation directly to the agency (through the mail or online at www.regulations.gov)."

//www.fda.gov/ForPatients/CommentonGuidance/default.htm

FDA rules have great impact on the nation’s health, industries and economy. These rules are not created by chance or in a vacuum. They are formed with the public’s help.

01/27/2017

FDA is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers. The FDA is taking imp...

01/11/2016

This South San Francisco startup has raised $68.4 million so far. The current round will fund hiring and clinical trials.

12/11/2015

..celebrating the progress..

(c) Leonie MarinovichLeonie MarinovichPhotographer and Advisor at The Stand International, Inc.FollowUnfollowFollowingLoadingWorld AIDS Day - Looking BackDec 1, 201524 views3 Likes0 CommentsShare on LinkedInShare on FacebookShare on Twitter Over the years, the images I have captured have moved fro…

08/22/2015

Now more than ever, the battle against polio turns to Pakistan and Afghanistan.

03/18/2015

We need a global warning and response system for infectious disease outbreaks.

01/13/2015

2014 was a good year for pharmaceutical innovation – the best, in fact, since the industry’s all-time record of 1996. FDA approved a total of 44 drugs – 39 by CDER, and 5 by CBER (Exhibit 1). As usual, this total excludes imaging agents (i.e., Lumason and Neuraceq), and only [...]

12/24/2014

The regulator noted in its early 2014 retrospective that it set a high mark for the number of approved rare disease drugs this year, and that insufficient information is the reason many breakthrough status requests get bounced.