Navigation Links
Former FDA Official Tim Cote Joins Emmaus Medical as Regulatory Advisor
Date:5/9/2013

TORRANCE, Calif., May 9, 2013 /PRNewswire/ -- Timothy Cote , M.D., MPH, former director of the Office of Orphan Product Development of the U.S. Food and Drug Administration, has joined Emmaus Medical, Inc., a specialty pharmaceutical and regenerative medicine company, in an advisory capacity, the company announced today.  Dr. Cote will advise Emmaus on the regulatory pathway for the company's sickle cell disease treatment.

"Dr. Cote's extensive regulatory knowledge and experience in rare diseases will be extremely beneficial as we move toward completion of our phase 3 clinical trial and into the analysis phase of the study," said Yutaka Niihara , M.D., MPH, founder and CEO of Emmaus Medical. "We remain on track to complete the study this year and look forward to working closely with Dr. Cote as we reach this important milestone, both for our company and the sickle cell disease community."

Dr. Cote is a leading national regulatory expert in orphan drug development. As a part of 22 years of federal service at the FDA, National Institutes of Health (NIH) and Centers for Disease Control (CDC), Dr. Cote served as the Director of the FDA Office of Orphan Products Development (OODP) from 2007 to 2011. The OODP is the FDA's primary interface with companies seeking orphan designation for drug and device products or seeking guidance in navigating FDA processes in reviewing orphan products.  Dr. Cote was instrumental in implementing the Orphan Drug Act and personally signed more than 800 orphan drug designations in his time at the Agency.

Dr. Cote also has served as Senior Federal Advisor to the Director, District of Columbia Department of Health; Branch Chief, Therapeutics and Blood Safety, FDA Center for Biologics Evaluation and Research (CBER); and Medical Director, Cancer Statistics Branch, National Cancer Institute. In 2011 Dr. Cote was the Chief Medica
'/>"/>

SOURCE Emmaus Medical, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Former NxStage Patient Nikolas Gieske Celebrates Kidney Transplant
2. Judge Upholds $3.3 Million Judgment In Favor of Fox Insurance Company Against Former Pharmacy Benefit Manager
3. Phonak and Special Olympics join forces with US Olympian, former Congressman Jim Ryun
4. Par Formulations (Formerly Edict Pharmaceuticals) Receives First ANDA Approval
5. Mike Golic, ESPN Radio Personality and Former Philadelphia Eagle, Holds Pre-Season "Training Camp" for People With Type 2 Diabetes
6. Lance Armstrong Update: Arrogant Even After Conceding Doping Charges, Asserts Former White House & WADA Spokesman Robert Weiner; Victory for Clean Sport but "Dark Message" Is Science Must Catch Up to Masking Agents Allowing Cheating
7. Cell Therapeutics, Inc. (CTI) Appoints Former Managing Director, Head of West Coast Biotechnology for Oppenheimer/CIBC Matthew J. Plunkett Executive Vice President, Corporate Development
8. Robert G. Savage, Former Worldwide Chairman, Johnson & Johnsons Pharmaceuticals Group, Joins Board of Nuovo Biologics, LLC
9. Prime Healthcare Hospitals Ranked as "Top Performers" by The Joint Commission
10. Omeros Responds to Misleading Announcement by Davis Wright Tremaine Concerning Settlement with Former Chief Financial Officer
11. NxStage Educational Reception at Annual Dialysis Conference Features Celebrity and Former NxStage User Stephen Furst
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... December 17, 2014 Revenue and earnings ... on research and development In the past 2013/14 ... by two percent to EUR 4.287 billion (last year: EUR ... 14 percent to EUR 360 million. "Overall, 2013/14 was a ... Michael Kaschke , President and CEO of Carl Zeiss AG. ...
(Date:12/17/2014)... Dec. 17, 2014 With advancements in ... MRI market is seeing new growth, according to ... scans account for the majority of market volume, ... of images, which are creating opportunities for more sophisticated ... is growing at a rate of 4%, with ...
(Date:12/17/2014)... , Dec. 17, 2014  ImmunoCellular Therapeutics, ... US Patent and Trademark Office (USPTO) has issued ... a dendritic cell-based immunotherapeutic vaccine targeting six tumor ... claims of US Patent No. 8,871,211, which issued ... cancer by administering a dendritic cell composition comprising ...
Breaking Medicine Technology:ZEISS Asserts its Position in Difficult Environment 2Kalorama: 3T Advancements Bringing New Growth to the MRI Market 2Kalorama: 3T Advancements Bringing New Growth to the MRI Market 3ImmunoCellular Therapeutics Announces Issuance of Key Patent For ICT-107 Cancer Vaccine 2
(Date:12/21/2014)... York, NY (PRWEB) December 21, 2014 ... nearing 1,400 in a consolidated litigation underway in New ... documents, a total of 1,375 claims involving the birth ... Superior Court. These lawsuits were filed by women who ... to have led to uterine perforations and other complications ...
(Date:12/21/2014)... AlignLife of Norton Shores is spreading Christmas ... time helping people get their health back. Mission for ... serving those persons in Muskegon County who are unable to ... of life. Dr. Michael Rykse wanted to do a Toy ... and he knew he found that when he heard what ...
(Date:12/21/2014)... San Francisco, California (PRWEB) December 21, 2014 ... announces his search for Vintage 1967 Jm Morrison and the ... D.C. concert posters. This would also be the only ... live. The concert was on Nov. 25, 1967. According ... in Washington D.C. They did play the Alexandria Roller ...
(Date:12/21/2014)... 21, 2014 Parker & Sons, Inc. ... cooling, plumbing and other similar home contractor services announces ... regard to its expert contracting services. The company is ... has been serving Arizona for well over 40 years. ... absolute best in quality customer service to the residents ...
(Date:12/21/2014)... December 21, 2014 Over the past ... issues in hundreds of emergency departments across the nation, ... findings have been translated into an innovative suite of ... correct deficiencies and enhance the patient experience. , ... physician staffing and management services for hospitals, announced the ...
Breaking Medicine News(10 mins):Health News:Mirena Lawsuits Approach 1,400 in Bergen County Litigation, Bernstein Liebhard LLP Reports 2Health News:Mirena Lawsuits Approach 1,400 in Bergen County Litigation, Bernstein Liebhard LLP Reports 3Health News:AlignLife of Norton Shores Makes a Brighter Christmas for Kids in Muskegon 2Health News:Parker & Sons Announces Record Number Of Favorable Reviews In 2014 With Regard To Its Expert Contracting Services 2Health News:Parker & Sons Announces Record Number Of Favorable Reviews In 2014 With Regard To Its Expert Contracting Services 3Health News:NES Health Launches Stipend Program for Emergency Physicians in Training to Financially Assist Emergency Department Doctors While They Learn 2
... has been selected for the Physician of the Year Award by ... surgeon director in Otolaryngology at the same Infirmary, will be presented ... Nov 20 in New York., ,Mehta graduated in medicine from ... He has been affiliated with the Infirmary for more than 25 ...
... 50 percent of the clan is found battling chronic skin ... new study has claimed that nearly 50,000 hair stylists are ... shampoos that render constantly moist hands., ,Due to this, ... on with their jobs when the condition worsens. Hairdressers are ...
... more salt than the deep blue sea, according to a ... brings about a dramatic reduction in their blood pressure which ... disease and stroke later in life. ,The report states ... Twirls contain more than twice as much salt as the ...
... that although very difficult to disseminate actual figures it ... of the funds allocated for the disbursement of medicines ... or lost because of fraudulent practices, bribery and diversion ... assessed that governments spent about US$50 billion (€39 billion) ...
... killer H5N1 avian flu virus that had emerged in early ... resistant to the vaccination programme and might even be aided ... wave of transmission of H5N1 avian flu and could potentially ... of the Proceedings of National Academy of Sciences. ,The ...
... regularly, because the size of your paunch is directly related ... new research conducted by a medical expert of Indian origin. ... University of Leicester, obesity has now become a worldwide epidemic. ... currently over half of women and two-thirds of men in ...
Cached Medicine News:Health News:Hair-raising issues of hairdressers 2Health News:Kids' Food: Saltier than the Deep Blue Sea 2Health News:Kids' Food: Saltier than the Deep Blue Sea 3Health News:Kids' Food: Saltier than the Deep Blue Sea 4
... dimeglumine) is a paramagnetic MRI contrast agent. ... gadobenate, a chelating agent that forms a ... ion. It is salified with meglumine forming ... all the physico-chemical features typical of gadolinium ...
... OMNISCAN was launched in the U.S. ... the central nervous system (CNS) to detect ... associated tissues. OMNISCAN has since received approval ... and pediatric CNS and body indications. OMNISCAN ...
... dimeglumine) injection was introduced in 1988, it ... magnetic resonance imaging (MRI). It became the ... MRI. Today, the product is still a ... neck and body. MAGNEVIST is used in ...
... in 1996, VISIPAQUE is the only isosmolar contrast ... osmolality equal to that of blood, VISIPAQUE was ... also the only contrast medium formulated with sodium ... In 1997, VISIPAQUE received FDA approval for use ...
Medicine Products: