Navigation Links
Advanced Life Sciences Announces Restanza(TM) Granted FDA Orphan Drug Designation for Plague and Tularemia
Date:9/15/2009

r the biodefense indications of anthrax, tularemia, and plague in the first part of 2010.

"We believe that Restanza is a major advance in biodefense preparedness against lethal pathogens, given its novel mechanism of action, demonstrated broad spectrum of activity against multiple bioterror agents and favorable safety profile," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "Pathogens such as anthrax, plague and tularemia represent extreme public health threats of potentially epidemic proportion as they are highly infectious and fatal diseases particularly if aerosolized, they can be deployed and spread quickly especially in densely populated areas. We look forward to continuing to work with the US government on the development of this promising new antibiotic and to meeting with the FDA to determine the regulatory pathway to approval for Restanza in the biodefense indications."

The FDA's U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Orphan Drug designation is awarded to compounds that offer potential therapeutic value in the treatment of rare diseases, defined as those affecting fewer than 200,000 Americans. This designation provides companies with financial and regulatory benefits such as eligibility for a special seven-year period of market exclusivity upon approval for the compound and indication with orphan designation, potential tax credits for research, potential grant funding for research and development, reduced filing fees for marketing applications, and assistance with clinical trial protocol review.

Restanza as a Biodefense Countermeasure

Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense. The FDA has designated Restanza as an orphan drug for the post-exposure pr
'/>"/>

SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Survival differences by race most apparent in advanced stages of breast cancer
2. Patients with Medicaid and those lacking insurance have higher risk of advanced laryngeal cancer
3. Advanced Age No Bar to Liver Transplant
4. Oncologists are critical in managing psychiatric disorders in patients with advanced cancer
5. Advanced technologies aim to transform the coaching of top athletes
6. Mecklenburg EMS Introduces Most-Advanced Situational Training in America for Emergency Medical Personnel
7. Advanced Life Sciences Joins NASDAQ Capital Market
8. Experimental drug shows promise in advanced kidney cancer
9. TCS Healthcare Technologies Announces Full Integration of Case Management Adherence Guidelines into Acuity Advanced Care(TM) System
10. OCuSOFT Refutes Comparison Time-Kill Study Released by Advanced Vision Research
11. U.S. Oncology Initiates Complete Phase Ib Trial of Brostallicin Combination Therapy in Advanced Solid Tumors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/16/2014)... 14, 2014 A new study found that ... stenting of true coronary bifurcation lesions yields similar ... DKCRUSH-VI clinical trial is the first study to ... were reported today at the 26th annual Transcatheter ... Cardiovascular Research Foundation (CRF), TCT is the world,s ...
(Date:9/16/2014)... 16, 2014 Programs and policies that ... of billions of dollars in savings for the US ... Commonwealth Fund. To help spur these types of improvements, ... 10 collaborative groups from across the country to field ... ) - a handbook designed to assist groups working ...
(Date:9/16/2014)... 2014 As part of its Latinos ... Citizens (LULAC) will host the second annual health festival ... feature free health screenings for osteoporosis, HIV, and high ... and cholesterol levels as well as bone marrow typing. ... under 6 years old , The event will also ...
(Date:9/16/2014)... Dennis Thompson HealthDay Reporter ... combination drug therapy aimed at opening the airways and ... older adults with chronic obstructive pulmonary disease (COPD), especially ... COPD patients who received a combination of long-acting beta ... or require hospitalization because of their breathing disorder, compared ...
(Date:9/16/2014)... NC (PRWEB) September 16, 2014 Danny ... on a Fall workshop tour with events throughout the ... the natural running movement and has taught a full ... is now offering ChiWalk-Run and ChiWalking tracks at his ... enjoy the benefits of the Chi techniques. , Workshop ...
Breaking Medicine News(10 mins):Health News:Results of DKCRUSH-VI trial reported at TCT 2014 2Health News:NQF Seeks Field Testing Groups for Population Health Guide 2Health News:NQF Seeks Field Testing Groups for Population Health Guide 3Health News:LULAC Hosts Second Annual Latinos Living Healthy Feria de Salud in Los Angeles 2Health News:Combo Therapy Best for COPD: Study 2Health News:Combo Therapy Best for COPD: Study 3Health News:Join ChiRunning® Founder, Danny Dreyer, on Fall 2014 US Workshop 2Health News:Join ChiRunning® Founder, Danny Dreyer, on Fall 2014 US Workshop 3
... tau helped in the reduction of Alzheimer’s symptoms in mice. ... treatment// to a deadly brain disorder, scientists hope. ... said, “If this strategy also works in humans, it could ... ,The researchers, whose work is published in the journal Science, ...
... Gastroenterology suggests that smoking may determine which part of ... from Crohn’s disease. Where the disease is located often ... ,“In patients who smoke, Crohn’s disease tends ... than the colon,” says study author Dr. Marian Aldhous. ...
... is seeking to raise glaucoma awareness among Mexican-Americans, who have ... Grande Valley Dispatch reports. ,Mexican-Americans over age ... history of glaucoma all face a higher risk for the ... most common form glaucoma. ,The rate increases ...
... American Cancer Society is launching a major new cancer research ... large-scale population research// in the United States to discover the ... ,The Cancer Prevention Study 3 (CPS-3) aims to enroll ... adults across the United States to help pave the way ...
... indicated that the culprit to most health threat is the ... and heating. According to the UN 5% of the preventable ... ,This study is based on a new estimate ... the physical, chemical, and biological characteristics of air in the ...
... women who like their meat smoked or barbequed. // ... consumed the most grilled, barbecued or smoked red meat over their ... meat-eaters who also skimped on fruit and vegetables had a 74 ... Susan E. Steck of the University of South Carolina in Columbia, ...
Cached Medicine News:Health News:American Cancer Society Launches Major New Study 2Health News:American Cancer Society Launches Major New Study 3Health News:Barbeque Lovers Warned To Load On Fruits And Vegetables 2
(Date:9/16/2014)... BETHESDA, Md. , Sept. 16, 2014 ... CHDX ) announced that, at a special meeting ... previously announced merger agreement (the "Merger  Agreement") by and ... Healthy Harmony Acquisition, Inc. ("Merger Sub"). Parent is an ... ("Fosun") and Ms. Roberta Lipson , the CEO ...
(Date:9/16/2014)... 16, 2014 Research and Markets has ... 2014-2018" report to their offering. Animal ... animals. Animal vaccines are generally prepared from weakened or dead ... healthy state. Some of the animal vaccines are also formulated ... subunits or toxic components. These components act ...
(Date:9/16/2014)... QPID Health , a leader in clinical ... Boston and their first West Coast ... 175 Franklin Street in Boston , and will ... new Southern California office will be ... help meet the demands of customers nationwide.  Both new locations ...
Breaking Medicine Technology:Chindex Stockholders Approve Merger 2Chindex Stockholders Approve Merger 3Global Animal Vaccines Market 2014-2018: Key Vendors are Bayer, Elanco, Merck, Novartis, Sanofi and Zoetis 2Global Animal Vaccines Market 2014-2018: Key Vendors are Bayer, Elanco, Merck, Novartis, Sanofi and Zoetis 3QPID Health Announces Major Office Expansion in Boston and Opens Facility in San Diego 2
... Researchers from the University of Cincinnati presented results from ... Society 2011 Annual Meeting today, demonstrating how PEM-guided ... for breast cancer patients.   PEM ... the location as well as the metabolic phase of ...
... F. Kennedy designated the month of May as Older Americans ... tradition to pay tribute to older adults. At that time, ... to the Administration on Aging. In 2009, this number totaled ... older adults rely on the support of their loved ones, ...
Cached Medicine Technology:Study Shows Same Day PET-Guided Biopsy May Expedite Pre-Operative Work-up For Breast Cancer Patients and Reduce Radiation Exposure 2May is Older Americans Month 2
... 265 is a highly accurate portable, waterproof system ... measurements. Temperature compensated pH results can be obtained ... a 3-in-1 electrode. • This GLP/GMP compliant system ... printer or a computer. Up to 100 data ...
... a highly accurate portable system for pH, mV ... pH results can be obtained when used with ... • This GLP/GMP compliant system includes an RS-232 ... computer. Up to 100 data sets can be ...
... Over-sized compressor. Triple pane thermal glass. ... System No plumbing required. Equipped with a ... on Parts & Labor and an Additional 4 ... as a chromatography unit which includes two access ...
... equipped, waterproof system for pH, mV (ORP), relative ... pH results can be obtained when used with ... Up to five custom buffers are supported. • ... to connect to a printer or a computer. ...
Medicine Products: