Navigation Links
FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Aspergillosis
Date:12/3/2013

NORTHBROOK, Ill., Dec. 3, 2013 /PRNewswire/ -- Astellas Pharma US, Inc., a subsidiary of Astellas Pharma Inc. based in Tokyo, Japan, announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis. QIDP status provides priority review and a five-year extension of market exclusivity if a product receiving such a designation is approved in the United States. These incentives were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as part of the FDA Safety and Innovation Act.

The possibility of a five-year extension is in addition to the potential seven-year exclusivity based on isavuconazole's FDA orphan drug designation for the treatment of invasive aspergillosis. In the U.S., isavuconazole also received orphan drug designation for the treatment of zygomycosis, a life-threatening invasive fungal infection (IFI) caused by emerging molds.

"Invasive aspergillosis and zygomycosis are life threatening infections that typically occur in severely immunocompromised patients. Acceptance of Aspergillus as a qualified pathogen is a recognition of the need for new treatment options for patients infected with these fungi," said Bernie Zeiher, Senior Vice President and Global Therapeutic Area Head of Immunology and Infectious Diseases at Astellas Pharma Global Development, Inc. "We applaud the bipartisan Congressional supporters of the GAIN Act for their commitment to encouraging investment in treatments for these serious infectious diseases through the passage of this legislation."

IFIs are debilitating or life-threatening infections that attack internal tissues or organs and can spread through the bloodstream. Fungi commonly involved in IFIs include Aspergillus (molds) and Candida (yeasts).[1], [2] Invasive
'/>"/>

SOURCE Astellas Pharma US, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. RadSite Grants Accreditation to First Wave of MIPPA Program Applicants
2. NASDAQ Grants China Jo-Jo Drugstores 180-Day Extension to Regain Compliance with Bid Price Requirement
3. U.S. FDA Grants Orphan Drug Designation for KaloBios KB001-A in Treatment of Cystic Fibrosis Patients
4. FDA Grants 510(k) Clearance for Innovative Fuse Gastroscope from EndoChoice
5. Philanthropic Grants, Product Launches, Promising Partnerships, and Customer Satisfaction Rankings - Research Report on CVS Caremark, Walgreens, McKesson, AmerisourceBergen, and Cardinal Health
6. Life Technologies Awards Digital PCR Innovation Grants to Five Research Labs
7. FDA Grants Lillys Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer
8. FDA Grants Orphan Drug Designation to Omeros OMS824 for Huntingtons Disease
9. European Union Grants a Good Manufacturing Practice Certificate to Nelson Laboratories
10. The Kenneth Rainin Foundation Continues its Commitment to Ending Inflammatory Bowel Disease, Awarding $1.5 Million in Research Grants
11. FDA Grants Orphan Drug Status To Eisais Investigational Compound (E7777) For Cutaneous T-Cell Lymphoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... Alemania, December 17, 2014 Los ... con un alto nivel de gasto en investigación y ... 2013/14 (finalizado el 30 de septiembre de 2014) ZEISS ... 4.287 millones de euros (año anterior: 4.190 millones de ... desfavorables. Las ganancias (EBIT) crecieron un 14 por ciento, ...
(Date:12/17/2014)... NEW YORK , Dec. 17, 2014 /PRNewswire-USNewswire/ ... resonance imaging (MRI), the MRI market is seeing ... cardiovascular and breast MRI scans account for the ... providing a higher resolution of images, which are creating ... resonance imaging (MRI) market is growing at a ...
(Date:12/17/2014)... N.J. , Dec. 17, 2014  IGI Laboratories, ... today the closing of its offering of $125 million ... 2019 (the "Notes").  The Notes were offered and sold ... under the Securities Act of 1933, as amended (the ... a fixed rate of 3.75% per year, payable semiannually ...
Breaking Medicine Technology:ZEISS confirma su posición en un entorno difícil 2Kalorama: 3T Advancements Bringing New Growth to the MRI Market 2Kalorama: 3T Advancements Bringing New Growth to the MRI Market 3IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 2IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 3IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 4
... PSTX) today announced that The Mount Sinai Hospital in New York City has implemented its Safety-Sponge System. , ... , , ... ... ...
... N.J. , March 15 Regado Biosciences, Inc., ... with active control agents, announced that Chris Rusconi , ... Zelenkofske , DO, FACC, Senior Vice President , Chief Medical ... on Monday, March 15, 2010 in Atlanta, ...
Cached Medicine Technology:Patient Safety Technologies, Inc., Contracts to Implement the Safety-Sponge(TM) System at The Mount Sinai Hospital in New York 2Patient Safety Technologies, Inc., Contracts to Implement the Safety-Sponge(TM) System at The Mount Sinai Hospital in New York 3Regado Biosciences, Inc. Introduces REG2, Its Second Product Candidate, at the American College of Cardiology Conference, 59th Annual Scientific Session, in Atlanta, Georgia on March 15, 2010 2Regado Biosciences, Inc. Introduces REG2, Its Second Product Candidate, at the American College of Cardiology Conference, 59th Annual Scientific Session, in Atlanta, Georgia on March 15, 2010 3Regado Biosciences, Inc. Introduces REG2, Its Second Product Candidate, at the American College of Cardiology Conference, 59th Annual Scientific Session, in Atlanta, Georgia on March 15, 2010 4
(Date:12/19/2014)... December 19, 2014 The Hermitage ... club in Southern Vermont’s Deerfield Valley, announced today that ... by classic rock songs. , Three time Grammy ... a private concert followed by a trail naming ceremony. ... trail names include: “I’m Alright” the theme song for ...
(Date:12/19/2014)... The tragic death from "rat-bite fever" of a 10-year-old San ... according to a report from the U.S. Centers for Disease ... potentially fatal illness that should be considered in persons with ... rodent exposure is reported," said a team led by Dr. ... case outlined in the report occurred in August of 2013. ...
(Date:12/19/2014)... Traveling through the same U.S. airport gate, one infected ... a four-hour time span, illustrating just how easily the ... exposures in this report were not prolonged and occurred ... the fact that measles is highly contagious," wrote a ... at the U.S. Centers for Disease Control and Prevention. ...
(Date:12/17/2014)... While countless companies tempt patients to buy hCG ... of their purchase. Not only is the sale of hCG ... patients who buy hCG online are typically receiving products that ... real hCG present. Illegal internet hCG is typically manufactured outside ... and may contain unknown fillers that can pose very serious ...
(Date:12/17/2014)... Providence, RI (PRWEB) December 17, 2014 ... nationally recognize private practices that have made outstanding ... and in support and progression of private practice ... the American Physical Therapy Association. , On behalf ... DPT, OCS, owner and CEO of Performance accepted ...
Breaking Medicine News(10 mins):Health News:The Hermitage Club Officially Names Four Ski Trails after Iconic Rock Songs by Grammy Award Winner Kenny Loggins 2Health News:Scratch From Pet Rat Kills Child; CDC Warns of Risk 2Health News:Arriving Now at Gate 42: Measles 2Health News:Arriving Now at Gate 42: Measles 3Health News:Diet Doc Reveals the Real Dangers for Those who Buy hCG Online 2Health News:Diet Doc Reveals the Real Dangers for Those who Buy hCG Online 3Health News:Performance Physical Therapy Awarded with Jayne L. Snyder Private Practice of the Year 2014 2
... InfoLogix,s e-Learning Team Develops Custom, Web-Based Training Solution ... Jan. 22 InfoLogix, Inc. (Nasdaq: ... of enterprise mobility and advanced wireless asset tracking ... today it has successfully deployed an advanced clinical ...
... and by male and female doctors, study finds , , ... heart failure is influenced by the gender of the ... evaluated 1,857 patients and the treatment records of 829 ... less likely to receive guideline-recommended medications, such as angiotensin-converting ...
... Clinic today announced the launch of its culture blog, Sharing Mayo ... and employees to share their stories about what makes Mayo Clinic ... ... -- Mayo Clinic today announced the launch of its culture blog, ...
... Initiatives, Inc. (Nasdaq: MTXX ), an over-the-counter ... consumers with "Better Ways to Get Better(R)," announced today ... ended December 31, 2008, will be released after the ... conference call will be held the following morning on ...
... a Difficult Target for Pharmaceutical Companies Wishing to Grow ... From Decision ResourcesWALTHAM, Mass., Jan. 22 /PRNewswire/ -- ... and advisory firms focusing on pharmaceutical and healthcare issues, ... ranks fourth in the number of untreated HIV patients ...
... Jan. 22 In 2008, The Larry King Cardiac,Foundation, ... individuals with no health insurance, increased the number of ... and continued to expand its,national network of partner hospitals. ... funds into individual medical procedures,the Foundation helped save the ...
Cached Medicine News:Health News:InfoLogix Develops Organizational Development and Mobility Training Solution for Edward Hospital 2Health News:InfoLogix Develops Organizational Development and Mobility Training Solution for Edward Hospital 3Health News:Gender May Influence Heart Failure Treatment 2Health News:Mayo Clinic Announces Sharing Mayo Clinic Blog for Patients, Employees 2Health News:Mayo Clinic Announces Sharing Mayo Clinic Blog for Patients, Employees 3Health News:Mayo Clinic Announces Sharing Mayo Clinic Blog for Patients, Employees 4Health News:Matrixx Initiatives, Inc. Sets Time for Discussion of Third Quarter Fiscal 2009 Financial Results 2Health News:Georgia Ranks Fourth in the Number of Untreated HIV Patients in the United States 2Health News:Georgia Ranks Fourth in the Number of Untreated HIV Patients in the United States 3Health News:2008 a Year of Growth and Unprecedented Service for The Larry King Cardiac Foundation 2Health News:2008 a Year of Growth and Unprecedented Service for The Larry King Cardiac Foundation 3
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: