HOME >> BIOLOGY >> NEWS
FDA grants Accentia Biopharmaceuticals...

Tampa, Fla. --Accentia Biopharmaceuticals, Inc. (Nasdaq:ABPI) has been notified that the U.S. Food and Drug Administration (FDA) granted Fast Track status to SinuNaseTM, the Company's intranasal Amphotericin B formulation. To the best of the Company's knowledge, SinuNase is the first and only drug candidate for chronic sinusitis (CS) to receive Fast Track status from the FDA.

Under the FDA Modernization Act of 1997, a new drug may be designated "Fast Track" provided the agency feels that the drug candidate has the potential to address unmet medical needs by treating serious or life-threatening conditions. With Fast Track status for SinuNase, Accentia is now eligible to submit a new drug license application (NDA) on a rolling basis, allowing the FDA to review sections of the NDA in advance of receiving Accentia's full submission, and permitting Accentia to apply for expedited review of its NDA.

Frank E. O'Donnell, Jr., M.D., Accentia's Chairman and CEO, commented: "Chronic sinusitis represents a substantial unmet clinical need, causing significant morbidity and expense. There is no approved pharmaceutical for the treatment of chronic sinusitis, despite 31 million affected patients in the U.S. alone, and about 500,000 patients who resort to sinus surgery each year in an attempt to control their chronic symptoms . These patients have chronic obstruction of the sinuses, which predisposes them to acute sinusitis, a bacterial super-infection for which more than 40 million antibiotic prescriptions are dispensed annually. The healthcare cost of chronic sinusitis is estimated at greater than $5 billion a year."

Accentia is preparing to commence its Phase 3 placebo-controlled clinical trial with SinuNase to treat post-surgical patients suffering from recurrent CS. The study is intended to be a four-month double-blinded comparison of symptomatic relief in patients randomized for treatment with either SinuNase or a placebo control.
'"/>

Contact: Adam Holdsworth
aholdsworth@investorrelationsgroup.com
212-825-3210
The Investor Relations Group
12-Apr-2006


Page: 1 2 3 4

Related biology news :

1. Gilbert Foundation and American Fed for Aging Research award grants on Alzheimers disease
2. New grants bolster efforts to generate faster and cheaper tools for DNA sequencing
3. New amfAR research grants to optimize HIV treatment
4. Ancient Etruscans were immigrants from Anatolia, or what is now Turkey
5. Berkeley Lab Life Sciences division awarded NIH grants for fruit fly, nematode studies
6. UAF researchers garner $6.5 million in NSF grants
7. Burroughs Wellcome fund awards $8.25 million in grants to physician-scientists
8. UCLA scientists garner 7 grants to fund leading-edge embryonic stem cell research
9. New medications, cancer diagnosis goals of UH engineers with $1M in grants
10. Barrow receives two grants worth a total of 900,000 from the ABRC
11. Kentucky first state to match federal SBIR-STTR Phase 1 and Phase 2 grants

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:12/22/2018)... ... December 21, 2018 , ... ... and hosted the Boston Healthcare Drinks event featuring Helen Chen, Greater China Managing ... China.” , The discussion was moderated by patent attorney David J. Dykeman ...
(Date:12/19/2018)... (PRWEB) , ... December 19, 2018 , ... InTouchMD’s flagship ... innovative products in healthcare for 2018. , PM360 is featuring the recognition in ... products and services offered to the pharmaceutical and medical device industries. , “This ...
(Date:12/18/2018)... ... December 18, 2018 , ... ... cancers and other serious diseases, today announced the publication of an early feasibility ... treatment of rGBM. , The publication of the study, An Early Feasibility ...
Breaking Biology News(10 mins):
(Date:1/7/2019)... ... January 07, 2019 , ... Kainos Medicine Inc. today announced ... candidate, code-named "KM-819." KM-819 is an orally active small molecule that is ... Korea. , This Phase 1 randomized, double-blind, placebo-controlled dose-escalation study was to ...
(Date:12/20/2018)... ... December 20, 2018 , ... New Year’s brings reflection and desire to improve ... the European Union (EU) on the horizon, Jim Kasic, president and CEO of Boulder ... the EU Medical Device Regulation (MDR), digital health, and big data are just a ...
(Date:12/18/2018)... ... ... Patients with early stages of breast cancer who undergo partial breast proton ... irradiation, a new study suggests. , Patients with early stage breast cancer — stage ... the cancerous tumor because there is a 30 to 40 percent change the disease ...
(Date:12/13/2018)... ... December 13, 2018 , ... Microbial Discovery Group LLC (MDG) ... been part of their strategic plan and an important milestone in increasing their ... opportunities for MDG within the $44 Billion human probiotic market. This plan is ...
Breaking Biology Technology:
Cached News: