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FDA Advisory Committee Recommends Approval of EVENITYTM (Romosozumab)

On January 16, the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) convened to review the safety and efficacy data from the pivotal Phase 3 studies for EVENITY™ (romosozumab). Eighteen of 19 BRUDAC members voted in favor of recommending approval of a biologics license application for the monoclonal antibody romosozumab for the treatment of osteoporosis in postmenopausal women at high risk for fracture, with two of 18 “yes” votes supporting a different indication for the drug. In its discussion, the Committee emphasized the need for post-marketing follow-up.

In committee discussions both before and after the vote, panel members unanimously called for additional data regarding the cardiovascular safety of romosozumab (EVENITY™, Amgen), with most members supporting either a randomized controlled trial or an observational study conducted after approval.

While the FDA is not bound by the Advisory Committee's recommendations, it takes the committee’s advice into consideration when making its final decision.

Read the full article here.

 

Now Accepting Applications for
ASBMR Volunteer Leadership Positions!

We need you! ASBMR volunteer leaders play an active role in developing and leading the worldwide research agenda in bone, mineral and musculoskeletal science. Nominate yourself or a colleague for a leadership position to actively contribute to ASBMR’s strategic goals, develop crucial leadership skills and make important career connections. The deadline for applications is March 11, 2019. Click here for more information and to submit a nomination!

 

Deadline Approaching: Apply Now for ASBMR’s Network of Minority Health Research Investigators (NMRI) Annual Workshop Travel Grant!

ASBMR recognizes the need to support research investigators from traditionally under-served communities. ASBMR is partnering with the Network of Minority Health Research Investigators (NMRI) Annual Workshop to provide a $1,500 travel grant to send an early career investigator to attend this event. The major objective of NMRI and its annual workshop is to encourage and facilitate participation of members of underrepresented population groups and others interested in minority health in the conduct of biomedical research in the fields of diabetes, endocrinology, metabolism, digestive diseases, nutrition, kidney, urologic and hematologic diseases. A second objective is to encourage and enhance the potential of investigators in choosing a biomedical research career in these fields.
 
To find out if you qualify and to begin the application, click here. The deadline to apply is Monday, February 19th.

 

Apply Now for the 2019 Phoebe Leboy Professional Development Award: Application Deadline February 22, 2019

With a new application process for 2019, the Phoebe Leboy Professional Development Award is for a female young investigator who resides outside the United States (preference given to those in an emerging and/or developing country). The award will provide the resources needed for the selected individual to attend the 2019 ASBMR Annual Meeting, mentorship from senior women in related areas of research, and membership in ASBMR. The award amount is up to $2,000. To read more about the award and eligibility requirements, click here. Applicants must submit a draft of the abstract they plan to present at the 2019 ASBMR Annual Meeting, one letter of support, a current CV, and a summary of their career objectives. Applications will open Monday, January 14 with an application deadline of February 22, 2019.

 

FASEB Excellence in Science 2020 Award Nominations Now Open!
Deadline is March 1, 2019

The ASBMR Women’s in Bone and Mineral Research Committee is asking for nominations for the two new FASEB Excellence in Science Awards in the Mid-Career Investigator and Early-Career Investigator categories. These awards are given in recognition of outstanding achievement by women in biological science. 
 
Award recipients will be expected to present an Excellence in Science Award Lecture at the annual meeting of a FASEB Member Society. Presentation of the award will take place in conjunction with the lecture. In addition to the unrestricted research grant, the award covers the recipients’ travel to/from the meeting, hotel expenses, complimentary meeting registration, and a plaque in recognition of the awardee’s achievement. Click here for more information. Please send your suggested nominations with a copy of a current CV or Biosketch to asbmr@asbmr.org.

FASEB will also be hosting a free webinar next Thursday, January 24th, 2019 titled "FASEB's Excellence in Science Award: Nomination Process & New Opportunities for 2020". This webinar will review the eligibility requirements, application process, and deadlines for the 2020 awards.The presentation will also address frequently asked questions regarding the nomination submission process. Please note that registration is required for this event, and can be found here.

 
JBMR® Highlights
The Radiology of Osteoporotic Vertebral Fractures Revisited
Brian Lentle, Fjorda Koromani, Jacques Brown, Ling Oei, Leanne Ward, David Goltzman, Fernando Rivadeneira, William D. Leslie, Linda Probyn, Jerilynn Prior, Ian Hammond, Angela Cheung, Edwin Oei, on behalf of the Vertebral Fracture Research Groups of the CaMos, STOPP and Rotterdam Studies
First Published: 15 January 2019
 
Lack of myosin X enhances osteoclastogenesis and increases cell surface Unc5b in osteoclast‐lineage cells
Bo Wang, Jin‐Xiu Pan, Huali Yu, Lei Xiong, Kai Zhao, Shan Xiong, Jun‐Peng Guo, Sen Lin, Dong Sun, Lu Zhao, Haohan Guo, Lin Mei, Wen‐Cheng Xiong
First Published: 15 January 2019
 
Tenofovir causes bone loss via decreased bone formation and increased bone resorption, which can be counteracted by dipyridamole in mice
Francisco Miguel Conesa, Patricia Llamas‐Granda, Ane Larrañaga‐Vera, Tuere Wilder, Raquel Largo, Gabriel Herrero‐Beaumont, Bruce Cronstein, Aránzazu Mediero
First Published: 15 January 2019
JBMR® Plus Highlights
Abstracts from the First Scientific Meeting of the Soft Bones Foundation
First Published: 22 December 2018
Bone Science in the News
Comparing Osteoporosis Screening, Treatment Strategies in Postmenopausal Women
Clinical Advisor (1/14/2019)
 
Study raises hopes for new approaches to treat osteoporosis
Medical News (1/11/2019)
 
Hormonal contraception may cause bone loss in adolescent girls
Endocrine Today (1/11/2019)
 
Hyponatremia increases fracture risk in diabetes
Endocrine Today (1/10/2019)
 
Osteoporosis: Addressing the Unmet Need
American Pharmaceutical Review (12/26/2018)
Events Calendar
February 18, 2019
NASEM Report Webinar: Breaking Through: the Next Generation of Biomedical and Behavioral Science Researcher
Online Webinar
 
February 20 - 22, 2019
8th International Conference on Frailty & Sarcopenia Research (ICFSR2019)
Miami Beach, FL United States
 
March 7 -8, 2019
32nd Euro Congress on Cancer Science & Therapy
Barcelona, Spain
 
March 11 - 12, 2019
U13 Bench-to-Bedside Conference: "Osteoporosis and Soft Tissue Disorders"
Bethesda, MD United States
 
March 17 – 19
IFMRS 3rd Herbert Fleish Workshop
Bruges, Belgium
Contact ASBMR
ASBMR Business Office
2025 M Street, NW
Suite 800
Washington, DC 20036-3309 USA
Tel.: +1 (202) 367-1161
Fax: +1 (202) 367-2161
Email: asbmr@asbmr.org


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