Navigation Links
FDA Grants Orphan Drug Status To Eisai's Lenvatinib
Date:2/14/2013

WOODCLIFF LAKE, N.J., Feb. 14, 2013 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its investigational drug lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer.

(Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO )

The Orphan Drug Act (ODA) allows FDA to grant orphan status to a drug which has the potential for the treatment, diagnosis, or prevention of a rare disease/disorder that affects fewer than 200,000 people in the United States.

Lenvatinib, discovered and developed by Eisai, is an investigational small molecule tyrosine kinase inhibitor being studied globally as an oral agent in patients with radioiodine-refractory differentiated thyroid cancer (DTC).

About Thyroid Cancer
Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea. It is more common in women than in men and usually occurs between the ages of 25 and 65.

The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 95 percent of all cases.  While most of these are curable with surgery and radioactive iodine treatment, a small percentage of patients do not respond to therapy. There are limited treatment options for this difficult-to-treat, life-threatening and resistant form of thyroid cancer.

Eisai Oncology
Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that can help make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission,
'/>"/>

SOURCE Eisai Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain
2. Community Foundation Announces $2.6 Million In Grants From Centinela Medical Funds
3. U.S. FDA Grants Priority Review to the New Drug Application for Bayers Regorafenib to Treat Patients with Metastatic Colorectal Cancer
4. European Commission Grants Orphan Medicinal Product Designation for Emmaus Medicals Sickle Cell Treatment
5. FDA Grants Orphan Drug Designation To GeNO LLC For Use Of Inhaled Nitric Oxide In Treatment Of Persistant Pulmonary Hypertension Of The Newborn (PPHN)
6. Rep. Fattah Announces More Than $10.7 Million in Grants for Neuroscience, Scientific and Medical Research in Philadelphia
7. U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment
8. Neuralstem Grants First Licenses For CNS Therapy Surgical Devices
9. EMA Grants Orphan Designation to Edison Pharmaceuticals for EPI-743 for Treatment of Leigh Syndrome
10. As Global Telemedicine Market Reaches $2.5 Billion, Industry Leaders Gather in San Diego to Discuss Grants, Funding, Vendor Selection, Credentialing, and More
11. Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... R.I. , Aug. 21, 2014 CVS Caremark ... tender results, applicable Reference Yields and consideration payable in connection ... commenced on August 7, 2014 for (1) any and all ... All Notes") and (2) up to a maximum amount of ... 2041 and 5.750% Senior Notes due 2017 (collectively, the "Maximum ...
(Date:8/21/2014)... Aug. 21, 2014  Cyberonics, Inc. (NASDAQ: CYBX ... 2014.  Quarterly highlights 1   ... to the first quarter of fiscal 2014, and other achievements, ... an increase of 6.8%; , Strong international net sales ... currency basis; , U.S. net product sales reached a ...
(Date:8/20/2014)... Aug. 20, 2014  The National Association of ... results achieved by the real-time, pseudoephedrine (PSE) blocking ... Precursor Log Exchange (NPLEx), automatically blocks unlawful PSE ... meth offenders and make arrests. Data released by ... blocked the sale of more than ...
Breaking Medicine Technology:CVS Caremark Corporation Announces Early Results of Tender Offers, Pricing, Election of Early Settlement and Increase in the Maximum Tender Offer Amount 2CVS Caremark Corporation Announces Early Results of Tender Offers, Pricing, Election of Early Settlement and Increase in the Maximum Tender Offer Amount 3CVS Caremark Corporation Announces Early Results of Tender Offers, Pricing, Election of Early Settlement and Increase in the Maximum Tender Offer Amount 4CVS Caremark Corporation Announces Early Results of Tender Offers, Pricing, Election of Early Settlement and Increase in the Maximum Tender Offer Amount 5CVS Caremark Corporation Announces Early Results of Tender Offers, Pricing, Election of Early Settlement and Increase in the Maximum Tender Offer Amount 6Cyberonics Reports Fiscal 2015 First Quarter Results 2Cyberonics Reports Fiscal 2015 First Quarter Results 3Cyberonics Reports Fiscal 2015 First Quarter Results 4Cyberonics Reports Fiscal 2015 First Quarter Results 5Cyberonics Reports Fiscal 2015 First Quarter Results 6Cyberonics Reports Fiscal 2015 First Quarter Results 7Cyberonics Reports Fiscal 2015 First Quarter Results 8Cyberonics Reports Fiscal 2015 First Quarter Results 9Cyberonics Reports Fiscal 2015 First Quarter Results 10Cyberonics Reports Fiscal 2015 First Quarter Results 11Cyberonics Reports Fiscal 2015 First Quarter Results 12Cyberonics Reports Fiscal 2015 First Quarter Results 13Cyberonics Reports Fiscal 2015 First Quarter Results 14Cyberonics Reports Fiscal 2015 First Quarter Results 15Cyberonics Reports Fiscal 2015 First Quarter Results 16Indiana's Stop-Sale System Achieves Significant Results In Battle Against Meth 2
... CITY, Mo., March 16, 2012  Argus Health Systems Inc., ... a National Council for Prescription Drug Programs (NCPDP) focus ... growing biopharmaceuticals industry. John Hill, vice ... NCPDP focus group. The NCPDP focus group, ...
... March 16, 2012 Echo Therapeutics, Inc. (Nasdaq: ... tCGM System as a non-invasive, wireless, transdermal continuous glucose ... drug delivery, today announced financial results for the year ... 10-K is available through Echo,s website at www.echotx.com ...
Cached Medicine Technology:Echo Therapeutics, Inc. Announces 2011 Financial Results 2Echo Therapeutics, Inc. Announces 2011 Financial Results 3Echo Therapeutics, Inc. Announces 2011 Financial Results 4Echo Therapeutics, Inc. Announces 2011 Financial Results 5
(Date:8/21/2014)... According to a new market report published by Transparency ... Size, Share, Growth, Trends and Forecast, 2012 - 2018," ... 236.1 million in 2011 and is estimated to reach ... a CAGR of 6.3% from 2012 to 2018. , ... . , Fundus cameras market growth in recent years ...
(Date:8/21/2014)... The worlds of personal care and ... chance to grab free products. BaliniSports will ... of Maine with all qualifying purchases for a limited ... friendly yoga apparel is simply perfect,” said Ada Hung, ... the two brands is intended to give people in ...
(Date:8/21/2014)... 21, 2014 Tibet has long been ... mysterious mountaintop kingdom. Prayers flags whip in the ... the low rumble of chanting monks fill the otherwise ... the world’, access to Tibet is challenging due to ... land can prove to be daunting for even the ...
(Date:8/21/2014)... David Mullings’ new book, Things #Entrepreneurs Say, ... of quotes from famous entrepreneurs to the not so ... on their challenging paths towards success. Earth Source Organics ... President and Founder Audrey Darrow alongside the bits of ... such as Oprah Winfrey, Steve Jobs, and Richard Branson, ...
(Date:8/21/2014)... 2014 Aspen Advisors, a U.S.-based healthcare consulting ... of Modern Healthcare’s Best Places to Work in Healthcare ... the healthcare industry for creating workplaces that enable employees to ... on employee responses to an employee engagement and satisfaction survey. ... has been named a “Best Places to Work in ...
Breaking Medicine News(10 mins):Health News:Fundus Cameras Market: Product Type- Mydriatic, Non-Mydriatic, Hybrid and ROP Cameras; End Users- Hospitals, Ophthalmology Clinics and Ophthalmic & Optometrist Offices 2Health News:Tom's of Maine Partner up with BaliniSports Yoga Apparel 2Health News:Earth Source Organics President Audrey Darrow Featured in New David Mullings Book 2Health News:Modern Healthcare Names Aspen Advisors Among the Top 100 Employers in the Healthcare Industry for a Fourth Consecutive Year 2
... on Series of Nationwide Investor MeetingsTUCSON, Ariz., May 8 ... ) today announced that, in connection with management,s upcoming meetings ... Securities and Exchange Commission its Spring 2009 Investor Presentation. ... free at the SEC,s website at http://www.sec.gov ...
... The federal government has made tax incentives accessible for ... implementation of simple automation into new or existing facilities ... a positive impact on organizations purchasing automated carousels and ... efficiencies and a high internal rate of return. The ...
... Six-Fold and Recurring Handpiece Sales Increase 22% on Comparable ... (OTC Bulletin Board: MLSS), the recognized leader in advanced ... for the three months ended March 31, 2009. ... 2009 with Three Months Ended March 31, 2008: ...
... N.J., May 8 Quest Diagnostics Incorporated (NYSE: ... and services, will conduct its annual meeting of shareholders on ... webcast will be accessible through the Investor Relations section of ... For those unable to listen to the live broadcast, ...
... Inc. (NTI(R)) (Nasdaq: NTII ) today announced ... March 31, 2009.Revenues for the third quarter of fiscal ... the third quarter of fiscal 2008. Research and development ... March 31, 2009 compared to $5.9 million for the ...
... Universal Capital Management, Inc. (OTC Bulletin Board: ... provides management and strategic growth resources to emerging ... Corporation ("Vystar") and Alatech Healthcare, LLC announced 510(k) ... (FDA) to market and sell Alatech,s Envy(TM) condom ...
Cached Medicine News:Health News:Providence Service Corporation Makes Its Spring 2009 Presentation Publicly Available 2Health News:Providence Service Corporation Makes Its Spring 2009 Presentation Publicly Available 3Health News:Providence Service Corporation Makes Its Spring 2009 Presentation Publicly Available 4Health News:Providence Service Corporation Makes Its Spring 2009 Presentation Publicly Available 5Health News:Providence Service Corporation Makes Its Spring 2009 Presentation Publicly Available 6Health News:Milestone Scientific Reports Strong Sales Growth in First Quarter 2009 Results 2Health News:Milestone Scientific Reports Strong Sales Growth in First Quarter 2009 Results 3Health News:Milestone Scientific Reports Strong Sales Growth in First Quarter 2009 Results 4Health News:Milestone Scientific Reports Strong Sales Growth in First Quarter 2009 Results 5Health News:Milestone Scientific Reports Strong Sales Growth in First Quarter 2009 Results 6Health News:Milestone Scientific Reports Strong Sales Growth in First Quarter 2009 Results 7Health News:Neurobiological Technologies Reports Third Quarter Fiscal 2009 Financial Results 2Health News:Neurobiological Technologies Reports Third Quarter Fiscal 2009 Financial Results 3Health News:Neurobiological Technologies Reports Third Quarter Fiscal 2009 Financial Results 4Health News:Universal Capital Management Reports Vystar(TM) Corporation Receives FDA Clearance for Envy(TM) Natural Rubber Latex Condom Made with Vytex(TM) NRL 2Health News:Universal Capital Management Reports Vystar(TM) Corporation Receives FDA Clearance for Envy(TM) Natural Rubber Latex Condom Made with Vytex(TM) NRL 3Health News:Universal Capital Management Reports Vystar(TM) Corporation Receives FDA Clearance for Envy(TM) Natural Rubber Latex Condom Made with Vytex(TM) NRL 4
Desmarres Retractor Size 4...
Desmarres Lid Retractor thin solid blades. Size 2....
... system introduces a new level ... microsurgical instrumentation. It has an ... with advanced microcomputer control of ... operate with a full range ...
Multiple Modulation Phaco (MMP) programmability with eight surgeon settings for maximum versatility. The combination of the peristaltic power balanced pump and the piezoelectric handpiece results in ...
Medicine Products: