UCB files BRIVIACT® (brivaracetam) CV in the U.S. as monotherapy treatment for adult epilepsy patien
Thursday, January 19, 2017 12:00 AM

Brussels (Belgium), Atlanta (Georgia, USA), 19 January 2017 – 18:30 (CET): UCB has today announced the filing of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for BRIVIACT® (brivaracetam) CV as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy within the U.S.

BRIVIACT® is currently approved in the U.S. as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy1. The most common adverse reactions (at least 5% for BRIVIACT® and at least 2% more frequently than placebo) in adjunctive therapy clinical trials were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Please see additional BRIVIACT® Important Safety information below.  Brivaracetam is not currently approved as monotherapy.

UCB submitted its supplemental application taking into account a recent General Advice Letter issued by the FDA2 which stated that it is “acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial onset seizures (POS) to their use as monotherapy for the treatment of POS”. The communication stipulates that, to support extrapolation, proposed dosages of a drug when used as monotherapy should result in exposures similar to those demonstrated to be safe and effective when the drug is used as adjunctive therapy and that adequate pharmacokinetic information must be provided “to demonstrate such similarity, taking into consideration possible drug-drug interactions (inhibition or induction) that may alter the metabolism of the drug”. UCB has included this information within its BRIVIACT® monotherapy supplemental application.

“We are very pleased to be able to submit a label change for brivaracetam to the FDA, to include its use as monotherapy for partial-onset seizures. The FDA’s agreement to the principle of extrapolation from existing data in their assessment of antiepileptic drugs has enabled us to base this submission on the existing wealth of brivaracetam data, less than a year after its launch as an adjunctive therapy in the U.S., and could improve patient access to the medicine if approved,” said Professor Dr. Iris Loew-Friedrich, UCB’s Chief Medical Officer.  “This submission, under the FDA’s extrapolation principle, allows us to use the strength of our brivaracetam clinical trials data, involving more than 2,400 adult patients with partial-onset seizures, and reinforces our longstanding commitment to develop and make available meaningful treatment solutions to improve the lives of people living with epilepsy.”

While the supplemental application of BRIVIACT® as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy in the U.S. has been accepted by the FDA, acceptance of this submission does not necessarily mean BRIVIACT®will be approved for this indication.

About Epilepsy3,4
Epilepsy is a chronic neurological disorder of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. In the U.S., 3 million people have epilepsy. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked seizures with a risk of further seizures. One third of patients with epilepsy live with uncontrolled seizures.

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of antiepileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy.

About BRIVIACT®1,5

BRIVIACT® is a new molecular entity that was rationally designed and developed by UCB. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT® exerts its anticonvulsant activity is not known. In the U.S. and European Union, BRIVIACT® is approved as adjunctive therapy (a therapy used together with primary treatment) in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. BRIVIACT® is available in three formulations (film-coated tablets, oral solution, and injection).

 

Source: UCB

 
Flow MedTech Announces Vice President of Medical Affairs (VPMA)
Monday, January 09, 2017 12:00 AM

DALLAS, TX — JANUARY 9, 2017 — Flow MedTech — Today Flow MedTech, Inc., an early-stage company developing an implantable medical device to prevent strokes in people with irregular heart rhythms, announces the appointment of Senthil Thambidorai, MD, FHRS, as Vice President of Medical Affairs.

Dr. Thambidorai completed a Cardiac Electrophysiology Fellowship at Cleveland Clinic in Ohio and a Cardiology Fellowship at the Creighton University-Department of Medicine in Nebraska. Dr. Thambidorai received his Doctor of Medicine, Bachelor of Medicine, Bachelor of Surgery from Kilpauk Medical College in India.

“With Dr. Thambidorai’s extensive training in left atrial appendage closures and experience with left atrial appendage closure devices, he is an incredible addition as well as a strong asset for our team,” said Arnab Chakraborty, Chief Product Officer and Chairman, Flow MedTech.

Dr. Thambidorai will lead Flow MedTech’s efforts by providing clinical input and vision during the research and development phase. He will also facilitate strategic partnerships to strengthen and further Flow MedTech’s position in the left atrial appendage closure market. His leadership to the Flow MedTech team will ensure the delivery of key objectives.

“We are thrilled to have Dr. Thambidorai join the Flow MedTech team. He brings a tremendous amount of perspective due to his experiences of implanting left atrial appendage closure devices in the Dallas/Fort Worth area,” said Christine Hang, Chief Executive Office, Flow MedTech. “It was important to us to bring someone on board who has the hands-on clinical experience to lead our medical affairs. Dr. Thambidorai will add profound value as we continue the development of Flow MedTech’s technology.”

Dr. Thambidorai will also continue his roles as the Regional Director of Electrophysiology for HCA North Texas, cardiologist and cardiac electrophysiologist in Fort Worth, TX, and a part of the academic core faculty for the Internal Medicine Residency Program at the University of North Texas in Fort Worth, TX. Dr. Thambidorai is a member of the American College of Cardiology and American Heart Association. He is the author of more than 13 peer-reviewed articles and more than 25 scientific presentations at national and international forums.

Source: Flow MedTech

 
Athenahealth to Add 500 Jobs in Atlanta, Double Footprint
Wednesday, January 04, 2017 12:00 AM

Healthcare tech company Athenahealth (Nasdaq: ATHN) will add about 500 jobs in Atlanta.

As part of the expansion, Athenahealth will double its office footprint, taking an additional 40,000 square feet at Ponce City Market in Atlanta's Old Fourth Ward, where it currently leases 98,000 square feet.

Athenahealth provides Internet-based electronic health records, practice management, and care coordination services to medical groups, hospitals and health systems. The company takes on non-core functions, such as claims processing, billing, patient communication and medical records management, allowing providers to focus on patient care.

Watertown, Mass.-based Athenahealth exceeded its projected employee growth rate by 40 percent in Atlanta, though it reportedly laid off 40 people in Atlanta in October 2016 due to restructuring efforts.

Athenahealth has already invested nearly $20 million in Georgia. It created 500 new jobs when it expanded into Georgia in June 2013.

 

Source: Atlanta Business Chronicle

 
Zika Vaccine Developer Names New Chief Scientific Officer
Written by Kristen Pappaterra   
Tuesday, January 03, 2017 12:00 AM

A Smyrna-based developer of vaccines against Zika, Ebola, HIV and other infectious diseases has named a new chief scientific officer.

Farshad Guirakhoo was promoted to the C-suite role at GeoVax Labs Inc. from senior vice president of research and development, his title upon joining the company in 2015. The promotion was effective Jan. 1.

His predecessor as CSO, company co-founder Harriet L. Robinson, will remain as chief scientific officer emeritus, the company said in a statement.

"For the past year, Farshad has been a driving force behind the growth of our vaccine development pipeline, and we are pleased to expand his role at this critical time for our company," GeoVax President and CEO Robert T. McNallysaid in the statement. "In the role of Chief Scientific Officer, Dr. Guirakhoo will lead the scientific advancement of GeoVax's technology pipeline as the Company identifies and pursues new opportunities to address significant medical needs."

Robinson will continue to direct the company's HIV vaccine program and to serve as principal investigator on National Institutes of Health grants to GeoVax, McNally said. Robinson will also continue to serve as a member of the GeoVax Board of Directors.

Before joining GeoVax in 2015, Guirakhoo served in senior management and scientific roles with biotechnology companies included Vaxess Technologies, Hookipa Biotech, Sanofi Pasteur, Acambis Inc. and OraVax Inc. He earned his Ph.D. in virology at the Medical University of Vienna in Vienna, Austria, and he holds a M.Sc. degree in genetics and a B.Sc. degree in biology. His post-doctoral training included a stint at the Centers for Disease Control and Prevention'sDivision of Vector-Borne Infectious Diseases in Fort Collins, Colo. Guirakhoo has filed over 90 patent applications in his scientific career, according to the statement, and was instrumental in the development and commercialization of the Imojev Japanese encephalitis virus vaccine and the Dengvaxia vaccine for Dengue virus.

GeoVax Labs Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases. Its development programs are focused on vaccines against HIV, Zika, and hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa).

In February 2016, The University of Georgia and GeoVax announced a collaboration to develop and test a possible Zika virus vaccine. Read more about GeoVax's work on an Ebola vaccine here and here.

 

Source: Atlanta Business Chronicle

 
Excellence in Biotech Education Awarded at 2016 BIO International Convention
Monday, May 30, 2016 12:00 AM

WASHINGTON--(BUSINESS WIRE)--The BioGENEius Challenges and Leadership Awards are organized by the Biotechnology Institute, a U.S. based organization dedicated to biotechnology education, and will be announced during the 2016 BIO International Convention, which is being held June 6-9 in San Francisco. Generous support from sponsors include Johnson & Johnson Innovation and the Biotechnology Innovation Organization.  

The Biotechnology Institute recognizes that its important constituencies aren’t just students that will be the future leaders of biotechnology, like the BioGENEius Challenge participants, but also those teachers, mentors and learning ecosystems that shape students’ education, and with them, their future and the future of biotechnology. 

The Biotechnology Institute formally recognizes those who expand our collective horizons of opportunity by inspiring the next generation of biotechnology innovators: 

  • The BioGENEius Hall of Fame Award honoring past finalists with a track record of outstanding accomplishments 
  • The BioGENEius Mentor Award honoring a STEM teacher or other significant influencer in the participating communities that serve the BioGENEius program 
  • The BioSTEM Leader Award honoring an outstanding K-12 school for their promotion and support of biotechnology education 

This year, the BioGENEius Hall of Fame Award, honoring past finalists with a pioneering spirit and determination to use biotechnology to make a difference in our lives was presented to Johnny Fells from New York. A past 2007-2009 BioGENEius finalist, Johnny just graduated from Columbia University with a B.S. in Industrial Engineering. He embodies the BioGENEius spirit by “giving back” - a BioGENEius who dedicates his free time to engage, excite and inspire young researchers in biotechnology by acting as a science fair judge, student mentor, inspirational speaker and personally granting special awards for students in less advantaged STEM educational environments. 

The BioGENEius Mentor Award recognizes STEM teachers and members of the BioGENEius community for their impact on the future growth of the biotechnology industry through career development. This year’s awardee, Marc Pedersen from Paulding County High School in Dallas, Georgia exemplifies it best. Marc has been recognized at the national, state and local levels for his excellence as a teacher and “covers it all” at Paulding from biotechnology to biology, chemistry, environmental science and AP physics. As a career mentor, he focuses students to utilize technology to investigate real problems within their own community. The value of their original research is reflected in their achievements at the Georgia Science and Engineering Fair and nationally at events such as the Siemens Math, Science and Technology Competition. To his students, Marc is simply “the best teacher!”

The Institute’s BioSTEM Leader Award honors outstanding K-12 schools for supporting biotechnology learning and the BioGENEius community through their “bio” STEM programs. This year, the Institute recognized Abraham Lincoln High School, in San Francisco, CA for the excellence of its STEM education programs and the dedication of its administration in its support of Lincoln’s Biotechnology Academy founded in 1995. The Academy has grown to 180 participating students who successfully compete nationally and internationally at events such as iGEM before moving on to college and career opportunities in many of California’s biotechnology companies. An essential lesson at the Academy is learning both the promise and limitations of biotechnology in order to develop the best solutions to real world problems. 

“The success of today’s STEM students, the future leaders of the biotechnology industry, rests on our ability to inspire, engage and promote their desire to realize the solutions that science can offer,” said Dr. Lawrence Mahan, President of Biotechnology Institute. “This year’s awardees are exceptional and we are delighted to honor them at BioGENEius during the 2016 BIO International Convention.” 

For additional information about the 2016 Leadership Awardees, visit www.biotechinstitute.org

About the Biotechnology Institute

The Biotechnology Institute is an independent, national non-profit organization dedicated to education about the present and future impact of biotechnology. Its mission is to engage, excite and educate the public, particularly students and teachers, about biotechnology and its immense potential for solving human health, food and environmental problems. For more information, visit www.biotechinstitute.org

 

Contact

For the Biotechnology Institute
Alexia Sikora (202) 295-8788
[email protected]

 
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