BIO recently published the July 2012 version of its quarterly therapeutic newsletters. These six newsletters focus on the therapeutic areas of member companies and include updates from biotech stakeholders around Washington, including Congress, FDA, NIH, and patient organizations.
The therapeutic areas covered by these newsletters are:
Cardiology, Pulmonology, & Blood
Nephrology, Endocrinology, Metabolism, & Gastroenterology
Allergy, Infectious Disease, & Antiviral
Rheumatology, Inflammation, Anesthesia, & Pain
Neurology & CNS
The below is an excerpt from the “Focus on Allergy, Infectious Disease, & Antiviral” newsletter. To download it in its entirety, please click here. If you have any questions or would like to receive a specific set of therapeutic newsletters, please contact Charles Crain at firstname.lastname@example.org.
NIAID Funding Announcements
PAR-12-174, Multidisciplinary Studies of HIV/AIDS and Aging(R21) – April 8, 2015
PA-12-090, New Technologies for Viral Hepatitis SBIR (R43/R44) – January 8, 2015
PA-11-014, HIV Infection of the Central Nervous System(R01) – January 8, 2014
RFA-AI-12-028, Understanding the Function of Uncharacterized Genes in Infectious Disease Pathogens(U19) – November 14, 2012
PAR-12-036, Investigations on Primary Immunodeficiency Disease(R01) – January 8, 2015
PAR-12-109, Targeting Persistent HIV Reservoirs(R21/R33) – April 26, 2014
PA-12-012, HIV Incidence Assays with Improved Specificity(R01) – January 8, 2015
FDA Advisory Committee News
On May 10, the FDA Antiviral Drugs Advisory Committee met to discuss an efficacy supplement for new drug application (NDA) 21-752, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead. The supplemental application proposes an indication for PrEP to reduce the risk of sexually acquired HIV-1 infection.
On May 11, the Committee discussed NDA 203-100, for a fixed dose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead. The application proposes an indication for the treatment of HIV-1 infection in adults who are antiretroviral naïve or have no known substitutions associated with resistance to the individual components.
For more information on these meetings, please click here.
NIAID Scientists to Test Maraviroc-based Drug Regimens for HIV Prevention
Scientists are launching the first clinical trial to test whether drug regimens containing maraviroc, a medication currently approved to treat HIV infection, are also safe and tolerable when taken once daily by HIV-uninfected individuals at increased risk for acquiring HIV infection. The eventual goal is to see if the drug regimens can reduce the risk of infection.
The trial involves a strategy known as pre-exposure prophylaxis, or PrEP, in which HIV-uninfected individuals who are at risk for contracting the virus take one or two HIV drugs routinely in an effort to prevent infection. Called Novel Exploration of Therapeutics for PrEP, or NEXT-PrEP, the two-year study is sponsored and funded by NIAID.
“The NEXT-PrEP study will examine whether maraviroc-based PrEP is safe and well-tolerated. It is a necessary first step before we can test the effectiveness of maraviroc-based PrEP, and in the future, potentially expand the selection of drugs that may be used in this emerging HIV prevention strategy,” said NIAID Director Anthony S. Fauci, M.D.
Led by principal investigator Roy M. Gulick, the study team will enroll 400 HIV-uninfected men who have sex with men (MSM) ages 18 and older in 12 cities in the United States and Puerto Rico. This trial builds on the results of the NIAID-sponsored iPrEx study, which found in 2010 that the daily PrEP regimen of oral tenofovir plus emtricitabine (brand name Truvada) reduced the risk of HIV infection in MSM by 43.8 percent.
To learn more about this research, please click here.
BIO Announces FDASIA and JOBS Act Webinars
BIO would like to invite you to participate in our upcoming educational webinar series in September and October on key provisions contained in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Jumpstart Our Business Startups (JOBS) Act.
The FDASIA webinars, scheduled for September 13 and September 26, will provide information on the intent and goals of the provisions in FDASIA, including Enhanced Communications, NME Reviews, Expanded Accelerated Approval, and Breakthrough Therapies. Industry experts will also discuss implementation issues and timelines.
The JOBS Act webinars, scheduled for September 18 and October 3, will offer companies information on the key facets of the law and offer expert analysis on how to navigate the new rules. The JOBS Act contains exciting new fundraising methods for biotech companies, including the IPO On-Ramp, Crowdfunding, and changes to SEC Regulations A and D.
The webinars are free for all BIO R&D members and BIO state affiliates. Non-member R&D companies are invited to join for $100. For more information or to register for the webinars, please email Charles Crain at email@example.com.
NCATS Announces Institutional CTSA Program
The NCATS CTSA program supports disease- and condition-specific networks funded by other NIH Institutes and Centers. NCATS has announced that its CTSA program will include Institutional CTSA Awards. Institutional CTSAs are made to degree granting institutions or groups of institutions that receive significant funding from the NIH. CTSAs require institutional commitment, the status of a major scientific and administrative entity within and across an applicant and partner institution(s), and a CTSA PD(s)/PI(s) with the authority and influence necessary to successfully create an institutional home for clinical and translational research.
To learn more about the NCATS Institutional CTSA Program (RFA-TR-12-006), please click here. The letter of intent is due December 10, 2012 and the application is due January 8, 2013.
To download the full “Focus on Allergy, Infectious Disease, & Antiviral” newsletter, please click here.