Navigation Links
FDA Grants Meridian Laboratories Pre-Ind Meeting for Captisol-Enabled Docetaxel in the Treatment of Cancer
Date:10/25/2012

CHICAGO, Oct. 11, 2012 /PRNewswire-iReach/ -- Buffalo Grove, Illinois-based specialty-oncology drug development company, Meridian Laboratories, Inc is pleased to announce that the US Food and Drug Administration (FDA) has granted Meridian's request for a Type B Pre-Investigational New Drug (pre-IND) meeting to discuss its plan to commence clinical trials of ML061 as a treatment for various cancer indications. The meeting is scheduled for January 23, 2012

Meridian's lead product, ML061, is an IP-protected reformulation of Taxotere in Captisol that eliminates Polysorbate-80 and could remove the associated "Black Box" warnings and precautions.  Meridian intends to seek approval with an abbreviated New Drug Application in the US with under SEC. 505(b)(2) [21 USC §355] New Drugs

Chairman Dr. William Zhao welcomed the response from the FDA. "We are pleased with this timely and positive response from the FDA. This is a significant step forward in the development of ML061." Meridian has assembled an accomplished biopharmaceutical development team including clinical and regulatory experts, Dr. G. Steven Geis and George Allen Hides. "Our proven team is already delivering outcomes." Dr. Geis, who is heading the clinical development of ML061, noted that Meridian Labs has a robust package of data to support regulatory submission through the US 505 (b)(2) regulatory pathway. "Following a successful pre-IND meeting, we expect to initiate a bioequivalence study in cancer patients in 2013."

About Meridian Labs

As the company's leading product, ML061 improves the formulation of Taxotere for cancer treatment, based on the same active ingredient docetaxel with a novel delivery method. By avoiding polysorbate 80 and ethanol, our objective is to show that ML061 improves the safety profile of Taxotere while maintaining its efficacy. We plan to bring the product to market as the top choice of chemotherapy for various cancer indications.

About AmeriTech Advisors

AmeriTech Advisors is an investment bank dedicated to providing capital raising and strategic advisory services to growth companies in the technology, medtech, and financial sectors with market capitalizations of between $25 million and $500 million. Their bankers have 20 years' experience at major global investment banks and as senior managers at public companies with experience executing successful transactions. Their goal is to build mutually beneficial relationships between our emerging growth company clients, technology and medtech/pharma partners, and their network of investors

Contact:

Dan D'Agostino

Managing Director, Investment Banking

AmeriTech Advisors

ddagostino@ameritechadvisors.com

1-212-209-3885

Media Contact: william zhao, Meridian Laboratories, Inc, 847-275-5923, william.zhao@meridian-lab.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE Meridian Laboratories, Inc
Copyright©2012 PR Newswire.
All rights reserved

Related biology news :

1. UNH labs receive 2 NSF grants totalling $1.35m for research instruments
2. Columbia awarded 1 of first Provocative Questions grants from NCI
3. New NIH/NHGRI grants to harness nanoscale technologies to cut DNA sequencing costs
4. 2 UNC faculty receive Autism Centers of Excellence grants for new research
5. 6 NARSAD Young Investigator Grants awarded to CAMH
6. American Health Assistance Foundation announces grants to advance promising vision research
7. Grants add to Northwestern-Qatar partnership
8. Bay Area PV Consortium announces $7.5 million in grants to lower the cost of large-scale solar
9. Scientist wins $3 million renewal of one of longest-running NIH grants to Scripps Research
10. Millennium Laboratories Launches New Assay to Detect Use of Kratom
11. 2012 ACMG Foundation/Signature Genomic Laboratories Travel Award winner announced
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2017)... April 17, 2017 NXT-ID, Inc. (NASDAQ: ... the filing of its 2016 Annual Report on Form 10-K on ... ... is available in the Investor Relations section of the Company,s website ... SEC,s website at http://www.sec.gov . 2016 Year Highlights: ...
(Date:4/11/2017)... N.Y. , April 11, 2017 ... fingerprints, but researchers at the New York University ... College of Engineering have found that partial similarities ... security systems used in mobile phones and other ... thought. The vulnerability lies in the ...
(Date:4/5/2017)... 2017 KEY FINDINGS The global ... a CAGR of 25.76% during the forecast period of ... factor for the growth of the stem cell market. ... MARKET INSIGHTS The global stem cell market is ... geography. The stem cell market of the product is ...
Breaking Biology News(10 mins):
(Date:5/24/2017)... ... May 24, 2017 , ... ... being developed with Wi-Fi connectivity to reduce the amount of wiring in a ... In addition, compact mobile devices including infusion pumps, heart and hypertension monitoring, glucose ...
(Date:5/23/2017)... , ... May 23, 2017 , ... A recent survey ... most troublesome and difficult to control weed in 12 categories of broadleaf crops, fruits ... 200 weed scientists across the U.S. and Canada participated in the 2016 survey, the ...
(Date:5/23/2017)... ... May 22, 2017 , ... ... row in the Aragon Research Globe™ for Corporate Learning, 2017. , Aragon Research ... and market demand, and effectively perform against those strategies. NetDimensions’ ranking as a ...
(Date:5/23/2017)... Woburn, MA (PRWEB) , ... May 23, 2017 ... ... light sources for advanced technology applications, has announced a facility expansion to accommodate ... add 3,000 square feet of new workspace and renovation of the existing areas. ...
Breaking Biology Technology: