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 Oncology” 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.
NCI Funding Announcements
PA-12-135, Translational Research at the Aging/Cancer Interface(R21) – May 8, 2015
PA-12-220, Biomarkers for Early Detection of Hematopoietic Malignancies(R21) – September 8, 2015
PA-12-213, Identifying Non-coding RNA Targets for Early Detection of Cancer(R01) – September 8, 2015
PA-12-082, Biomechanisms of Peripheral Nerve Damage by Anti-Cancer Therapy(R21) – May 5, 2012
PA-11-159, Biomarkers of Infection-Associated Cancers(R01) – May 8, 2014
PA-11-073, Mitochondria in Cancer Epidemiology, Detection, Diagnosis and Prognosis(R21) – January 8, 2014
PAR-12-140, Role of the Microflora in the Etiology of Gastro-Intestinal Cancer(R01) – March 5, 2014
FDA Advisory Committee News
On June 20, 2012, the FDA Oncologic Drugs Advisory Committee met to discuss NDA 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC. The proposed indication for this product is for the prophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk score ≥ 3.
The Committee also discussed NDA 202714, with the proposed trade name Kyprolis (carfilzomib) for injection, application submitted by Onyx Pharmaceuticals, Inc. The proposed indication for this product is for the treatment of patients with relapsed and refractory (recurring and/or not responsive to other treatments) multiple myeloma who have received at least 2 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent.
The materials and minutes from this meeting are available online, as well as a complete transcript. For more information, please click here.
Scientists Make Breakthrough in Bile Duct Cancer with Discovery of Gene Mutations
A team of international scientists has made a significant breakthrough in understanding the cause of bile duct cancer. By identifying several new genes frequently mutated in bile duct cancers, researchers are paving the way for better understanding of how bile duct cancers develop.
Research team leader Dr. Bin Team Teh said the study will pave the way for a better understanding of the roles that newly identified genes play in the development of bile duct cancer. “This discovery adds depth to what we currently know about bile duct cancer,” said Teh. “More important is that we are now aware of new genes and their effects on bile duct cancer, and we now need to further examine their biological aspects to determine how they bring about the onset of Cholangiocarcinoma.”
Using state of the art DNA sequencing, the researchers analysed eight bile duct cancers and normal tissues from Thai patients, and discovered mutations in 187 genes. The team then selected 15 genes that were frequently mutated for further analysis in an additional 46 cases. Many of these genes, such as MLL3, ROBO2 and GNAS, have not been previously implicated in bile duct cancers.
“With this finding we now know much more about the molecular mechanisms of the disease and we can draw up additional measures that can be taken while we identify the most appropriate treatment protocols. We are talking about the potential to save many lives in Thailand,” said Professor Vajarabhongsa Bhudhisawasdi.
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 Oncology” newsletter, please click here.