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 Rheumatology, Inflammation, Anesthesia, & Pain” 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 email@example.com.
NIAMS Funding Announcements
PAR-12-230, Identification and Analysis of Causal Variants: Follow-Up on Genome-Wide Association Studies for Arthritis and Musculoskeletal and Skin Diseases(R21) – November 21, 2013
PA-12-191, Multiplex Assay Development for Arthritis and Musculoskeletal and Skin Diseases(SBIR [R43/R44]) – September 8, 2015
PA-10-006, Mechanisms, Models, Measurement, & Management in Pain Research(R01) – January 8, 2013
PA-12-018, Mechanisms Mediating Osteoarthritis in Aging(R21) – January 8, 2015
PAR-10-282, Pilot and Feasibility Clinical Research Grants in Arthritis and Musculoskeletal and Skin Diseases(R21) – July 2, 2013
FDA Advisory Committee News
On May 9, 2012, the FDA Arthritis Advisory Committee met to discuss new drug application (NDA) 203214, tofacitinib tablets, Pfizer Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Tofacitinib is an inhibitor of the Janus kinase (JAK) family. In kinase assays, tofacitinib inhibits JAK1, JAK2, JAK3 and, to a lesser extent, TyK2. The product is being proposed as immediate-release tablets for oral administration in 5 and 10 mg dosage strengths.
The materials and minutes from this meeting are available online, as well as a complete transcript. For more information, please click here.
NIAMS: Post-Injury Response Could Be Key Step in Osteoarthritis Development
Scientists long considered osteoarthritis (OA) a disease of wear and tear. Use the joints long enough, they reasoned, and they are bound to wear out. But research in recent years has suggested that inflammation plays a role in OA, a disease in which joint cartilage breaks down, leaving bone rubbing against bone. A new study, supported in part by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, helps confirm that role and points to new targets for treatment, and perhaps prevention, of this common joint disease.
The study, conducted in the laboratory of William Robinson, M.D., Ph.D., at Stanford University, found that a pathway called the complement system, which is a major component of the innate immune system, is critical to the development of OA. Through analyses of joint tissue and joint fluid from individuals with OA, they found that expression and activation of complement is abnormally high in people with OA. The innate immune system is designed to protect the body from harmful invaders such as viruses and bacteria. When cartilage is injured, the researchers found, the complement system is activated, leading to inflammation directed against the body’s own tissues.
While previous research has shown evidence of complement activation in severe, long-standing OA, this study is the first to show the system’s activation may play an important role in the initiation of osteoarthritis and its early progression, says V. Michael Holers, M.D., head of one of the study groups at the University of Colorado.
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 firstname.lastname@example.org.
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 Rheumatology, Inflammation, Anesthesia, & Pain” newsletter, please click here.