21st Century Cures Tracker monitors enactment of key provisions relevant to biomedical innovation | "But that's the way we've always done it!" Join FasterCures' free webinar on organizational culture change | Boston, San Francisco are biggest biotech clusters in US
Researchers reported in Science that a computer simulation to analyze how morphine-like molecules interact with opioid receptors uncovered a mechanism of action that may lead to development of a pain drug that does not have the side effects associated with opioids, including dependence. A proof-of-concept study presented at the American Academy of Pain Medicine's annual meeting showed a kappa opioid receptor agonist compound that does not cross the blood-brain barrier may relieve pain without the risk of abuse.
The 21st Century Cures Act is landmark, bipartisan legislation that touches virtually all aspects of biomedical research, medical product development and the regulatory approval process. FasterCures worked closely with Congress, federal agencies and the advocacy community throughout the legislation's journey to the president's desk. Now we are proud to debut the 21st Century Cures Tracker to track the implementation of the 100+ sections in Division A, which include the key provisions relevant to biomedical research and innovation. Explore this new resource today!
Changing organizational culture is a universal concept, so we've designed a must-attend webinar examining these issues on Wednesday, March 29, from 2 p.m. to 3 p.m. Eastern. We'll be discussing what we know about how change happens, what incentives need to be in place to produce the behaviors we want to see and how the next generation of research leaders is changing the playing field. Register to attend today!
Boston and San Francisco are the main two biotech centers in the US and startups in these two clusters outperform competitors in other parts of the country, writes Bruce Booth. Both of these clusters are gaining talent and scooping up greater portions of available venture capital.
Adron Harris at the University of Texas at Austin says novel treatments for alcoholism may already exist but are being used for other purposes, so he is searching for existing prescription drugs that can be reconfigured so they turn off genes that cause problems for people addicted to alcohol. Harris has identified a couple of drugs that have shown promise in animal studies and expects to start human clinical trials within the year.
Data collaborations and consortiums often fail because of privacy, collection and analysis issues, but it is important they succeed because they can lead to faster discovery of treatments and promote combination therapies, writes Definiens Chief Medical Officer Ralf Huss. "Pharmaceutical companies are realizing they can achieve more, both economically and scientifically, if they collaborate rather than only compete against each other to be first to market," Huss writes.
Astellas Pharma agreed to collaborate with X-Chem to use the latter's DNA-encoded DEX libraries of over 120 billion compounds to develop novel lead compounds for complex drug targets in multiple therapeutic areas. X-Chem will receive an upfront payment of $16 million plus research funding and license and option fees as the partnership progresses.
La Jolla Pharmaceutical, a developer of drugs for hereditary blood diseases, is seeking to raise $100 million through a public offering of stock. The funds will be used to finance clinical trials for drugs, including a regulatory hormone for iron metabolism as well as a medication for rare genetic diseases and bacterial infections.
A Series B financing round has pulled in $64 million for Sutro Biopharma spinout SutroVax. The funding will be used to support a midstage trial of the company's lead pneumococcal conjugate vaccine candidate.
A report found using the FDA's 505(b)(2) pathway, designed to allow the agency to consider data not developed by applicants to speed up the drug approval process, took an average of about five months longer than the application process for new molecular entities. Part of the problem could be a greater number of 505(b)(2) applications, combined with staffing strains at the FDA, according to FasterCures, which likened the FDA's staffing issues to "a basketball team with just four players on the court."
The Government Accountability Office confirmed it will investigate the FDA's orphan drug program for potential abuses after three US senators requested the probe. The investigation, which is expected to begin in nine months, will include a request for a listing of drugs approved or denied orphan status by the FDA, an evaluation of whether reviews are consistent and an analysis of the FDA's ability to keep up with orphan drug applications.
The National Brain Tumor Society launched the Clinical Trial Finder, developed by brain tumor survivor Michael Wenger, to increase awareness about trials for brain tumor treatments and get more patients involved in them. The group also is working on programs to improve the research process, empower patients and give patients more input into development of clinical trials.
FasterCures is an action tank that works across sectors and diseases to improve the effectiveness and efficiency of the medical research enterprise. FasterCures, a center of the Milken Institute, is nonpartisan and independent of interest groups.
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