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:4/5/2017)... -- Today HYPR Corp. , leading innovator in ... the HYPR platform is officially FIDO® Certified . ... that empowers biometric authentication across Fortune 500 enterprises and ... 15 million users across the financial services industry, however ... suites and physical access represent a growing portion of ...
(Date:3/30/2017)... , March 30, 2017  On April 6-7, 2017, ... the Genome hackathon at Microsoft,s headquarters in ... competition will focus on developing health and wellness apps ... Hack the Genome is the first hackathon ... The world,s largest companies in the genomics, tech and ...
(Date:3/28/2017)... PUNE, India , March 28, 2017 ... (Analog, IP, Biometrics), Hardware (Camera, Monitors, Servers, Storage Devices), ... Maintenance), Vertical, and Region - Global Forecast to 2022", ... 30.37 Billion in 2016 and is projected to reach ... 15.4% between 2017 and 2022. The base year considered ...
Breaking Biology News(10 mins):
(Date:10/12/2017)... BOSTON (PRWEB) , ... October 12, 2017 , ... ... name for two-dimensional representations of a complex biological network, a depiction of a ... a big mess,” said Dmitry Korkin, PhD, associate professor of computer science at ...
(Date:10/12/2017)... ... October 12, 2017 , ... AMRI, ... and biotechnology industries to improve patient outcomes and quality of life, will now ... testing are being attributed to new regulatory requirements for all new drug products, ...
(Date:10/11/2017)... Palo Alto, CA, USA (PRWEB) , ... October 11, 2017 , ... ... is set to take place on 7th and 8th June 2018 in San Francisco, ... and policy influencers as well as several distinguished CEOs, board directors and government officials ...
(Date:10/11/2017)... Austin, TX (PRWEB) , ... October 11, 2017 ... ... in August compared the implantation and pregnancy rates in frozen and fresh ... the contribution of progesterone and maternal age to IVF success. , After comparing ...
Breaking Biology Technology: