Navigation Links
U.S. FDA Grants Orphan Drug Designation for KaloBios' KB001-A in Treatment of Cystic Fibrosis Patients
Date:10/30/2013

the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type that was previously granted the designation for the same indication. Orphan designation also provides tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About KaloBios

KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies designed to treat severe life-threatening or debilitating diseases for which there is an unmet medical need, with a clinical focus on severe respiratory diseases and cancer.

Currently, KaloBios has three drug development programs:

  • KB003, an anti-GM-CSF mAb with potential to treat inflammatory diseases, being developed for the treatment of severe asthma. Enrollment of 160 patients has been completed in a Phase 2 study in the United States, Europe and Australia.
  • KB001-A, an anti-PcrV mAb fragment that is partnered exclusively with Sanofi Pasteur and is being developed for the prevention and treatment of Pa infections. KaloBios has retained rights for the CF indication and has initiated a 180 patient Phase 2 study in CF subjects with chronic Pa lung infection in the United States.  KaloBios has received Orphan Drug designation from both the FDA and the European Commission for KB001-A for the treatment of Pa lung infection in CF. Sanofi is pursuing a ventilator-associated pneumonia prevention indication in the intensive care setting, an indication which has received U.S. FDA Fast Track Designation.
  • KB004, an anti-EphA
    '/>"/>

SOURCE KaloBios Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

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:10/30/2014)... Oct. 30, 2014  Electronic health records uptake ... result of government initiatives and the considerable resources ... have invested over the past five years. Electronic ... IT, and U.S. clinicians use them on a ... http://photos.prnewswire.com/prnh/20141029/155278LOGO Frost & Sullivan,s ...
(Date:10/30/2014)... WOONSOCKET, R.I. , Oct. 30, 2014 CVS ... entered into new clinical affiliations with three leading regional health ... for patients. The collaborating health systems include Baptist Health System ... affiliated hospitals which include Commonwealth Health in Pennsylvania ... Arizona , and Tennova Healthcare in ...
(Date:10/30/2014)... China Biologic Products, Inc. (NASDAQ: CBPO, "China Biologic" or ... in China , today announced that ... results on Wednesday, November 5, 2014 after the market ... a conference call at 7:30 a.m. Eastern Time on ... Time on November 6, 2014, to discuss third quarter ...
Breaking Medicine Technology:Electronic Health Record Usability: CIOs Weigh In 2Electronic Health Record Usability: CIOs Weigh In 3Electronic Health Record Usability: CIOs Weigh In 4CVS Health Announces New Clinical Affiliations with Leading Regional Health Systems 2CVS Health Announces New Clinical Affiliations with Leading Regional Health Systems 3CVS Health Announces New Clinical Affiliations with Leading Regional Health Systems 4China Biologic to Report Third Quarter 2014 Financial Results 2
... of a new cytokine called IL-35 could allow clinicians ... response, MEMPHIS, Tenn., Nov. 21 Investigators at ... molecule,that prevents immune responses from running amok and damaging ... new treatments for cancer, using,vaccines; for autoimmune diseases, such ...
... Nov. 20 A new study,released by Indiana ... in immediate and significant improvements in heart,health, particularly ... decrease in,hospital admissions for heart attacks, also known ... prior cardiac history in Monroe,County, Indiana versus the ...
Cached Medicine Technology:St. Jude Finds Molecule That Could Improve Cancer Vaccine and Therapy for Other Diseases 2Smokefree Workplace Law Reduces Heart Attacks 59% Among Nonsmokers, New Research Shows 2
(Date:10/31/2014)... Thompson HealthDay Reporter THURSDAY, ... Thursday an additional $100 million in the fight against the ... which brings the World Bank,s total pledge to more than ... care workers to the three hardest-hit countries -- Guinea, Liberia ... Ebola crisis has increased significantly in recent weeks, but we ...
(Date:10/31/2014)... by the National Institutes of Health will facilitate ... reframe mental health research, from diagnosis to treatment. ... established by the National Institute of Mental Health ... of the institute,s RDoC initiative. , The ... the pace of research that translates basic science ...
(Date:10/31/2014)... HealthDay Reporter THURSDAY, Oct. 30, ... organ transplantation is nothing new. The first kidney transplant ... in 1963 and the first human heart transplant in 1967. ... patient,s entire face. One major organ still eludes the ... team of U.S. scientists has its way, that dream may ...
(Date:10/31/2014)... News) -- The number of medical malpractice payments in ... to a new study. And compensation payment amounts ... or declined in recent years, researchers report online Oct. ... Association . "For many physicians, the prospect of ... of modern clinical practice," researchers, led by Michelle Mello, ...
(Date:10/31/2014)... WASHINGTON, DC (October 31, 2014) — A new ... (Milken Institute SPH) at the George Washington University ... for pregnant women who are enrolled in Covered ... which includes the Comprehensive Perinatal Services Program (CPSP). ... the nation,s most successful programs ever developed for ...
Breaking Medicine News(10 mins):Health News:World Bank Pledges $100M More to Fight West Africa's Ebola Outbreak 2Health News:NIMH creates new unit to support its research domain criteria initiative 2Health News:Scientists Set Their Sights on First Whole-Eye Transplant 2Health News:Scientists Set Their Sights on First Whole-Eye Transplant 3Health News:Fewer Malpractice Claims Paid in U.S. 2Health News:Report examines health care challenges for pregnant women enrolled in covered California 2
... cancer of the eye need not have to remove their ... The results of the Collaborative ocular Melanoma ... found that survival rates were the same regardless of whether ... radiation therapy.// , Davidorf, Professor ...
... affects women in their 30s and 40s, especially women.The illness ... cause pain, inflammation and joint destruction. , ... condition, but one third of the patients discontinue treatment early ... taking Methotrexate are prone for their drug-related liver damage .This ...
... exercise can improve their health or it would not make a ... Consensus statements published by the American College of ... researchers often can't tell how much health-improvement pay-off will result from ... make a difference at all. , , ...
... levels is becoming an increasingly important part of a medical ... or 'good' cholesterol) levels should be high, and low density ... At Johns Hopkins ... to measure non-HDL cholesterol too. This is the difference between ...
... to kill the deadly Hepatitis E virus has been designed by ... would kill the virus by cutting RNA. , , ... animals. The cloned virus could also be used for diagnostic purposes ... For this, the team had produced ...
... in tomato products, such as tomato sauce and ketchup, have ... especially prostate cancer, but the reason for such an action ... that lycopene, which is found in tomato products and other ... and treating the disease in its earliest stages.// ...
Cached Medicine News:Health News:How much can exercise improve health? 2Health News:Protective effects of tomatoes in prostate cancer 2
A flexible hematology platform:, 32 parameters, Automatic result validation, Cytology atlas included, CBC and 5+3 DIFF...
... L.E.D. is mounted coaxially on the loupe ... battery pack giving 4 hours continuous use. ... and a charging unit that can hold ... as being a convenient container to keep ...
The PDM utilizes the latest technology for measuring interpupillary distance and left/right pupil-to-nose distance. Lightweight and easy-to-use, the PDM provides accurate and repeatable PD measuremen...
Inquire...
Medicine Products: