Navigation Links
Coyote Pharmaceuticals Initiates GMP Manufacturing Process for CNS-102 Following Successful Pre-IND Meeting
Date:2/13/2013

MENLO PARK, Calif., Feb. 13, 2013 /PRNewswire/ -- Coyote Pharmaceuticals, Inc., an emerging biopharmaceutical company focused on neurodegenerative diseases, announced today that it has initiated the GMP manufacturing process for CNS-102 following its recent pre-IND meeting with the Food and Drug Administration (FDA).  CNS-102 is being developed initially to treat amyotrophic lateral sclerosis (ALS).

In its meeting with the FDA, Coyote was advised to apply for Fast Track designation when it submits its Investigational New Drug (IND) application for CNS-102 for the treatment of ALS.  Coyote expects to file its IND in the fourth quarter of 2013 and commence a Phase 1 clinical study of CNS-102 in early 2014.

"Initiating the GMP manufacturing process for CNS-102 signals the first step in our clinical development program for ALS and follows a successful meeting with the FDA in which we were advised to seek Fast Track designation for CNS-102 in ALS," commented Hiroaki Serizawa , Ph.D., president, CEO & co-founder of Coyote Pharmaceuticals.  "Given that Fast Track designation is not typically discussed until Phase 2 data is produced, we view the FDA's position as very encouraging for our technology and strategy of targeting heat shock protein induction as a potential treatment for ALS."

According to the FDA, Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need.  The purpose is to get important new drugs to the patient earlier.  Most drugs eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review.  A Priority Review means that the time it takes FDA to review a new drug application is reduced.  The goal for completing a Priority Review is six months.

About Coyote Pharmaceuticals:
Coyote Pharmace
'/>"/>

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

Page: 1 2

Related medicine technology :

1. Founder of Nestle-Acquired Company Joins Prismic Pharmaceuticals
2. RQx Pharmaceuticals and Genentech Enter Drug Discovery Collaboration to Develop Novel Drug Compounds
3. Vanda Pharmaceuticals Reports Fourth Quarter 2012 and Full Year 2012 Results
4. Jazz Pharmaceuticals To Report 2012 Fourth Quarter And Full Year Financial Results On February 26, 2013
5. DelMar Pharmaceuticals Announces $1.0 Million Third Closing in Private Placement
6. Perrigo Company Acquires U.K.-based Rosemont Pharmaceuticals Ltd. For Approximately £180 Million Or $283 Million
7. Inovio Pharmaceuticals, Inc. Investor Presentation Now Available for On-demand Viewing at RetailInvestorConferences.com
8. Imprimis Pharmaceuticals Announces Pricing of Public Offering of 1,840,000 Shares of Common Stock
9. Anthera Pharmaceuticals to Present at the 2013 Leerink Global Healthcare Conference
10. Avanir Pharmaceuticals Reports Fiscal 2013 First Quarter Financial And Business Results
11. Shares of Oramed Pharmaceuticals Are Approved for Listing on the Nasdaq Capital Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/1/2015)... CITY, Calif. , May 1, 2015  AcelRx Pharmaceuticals, ... focused on the development and commercialization of innovative therapies ... announced that Timothy E. Morris , chief financial ...  Details of the events are as follows: ... May 5 Location:  The Omni Berkshire Place, ...
(Date:4/30/2015)... MOUNTAIN VIEW, Calif., April 30, 2015 Omnicell, Inc. ... and supply management solutions to healthcare systems, today announced ... GAAP results: Revenue for the first quarter ... 14.2% from the first quarter of 2014, and down ... 2014. First quarter 2015 net income as ...
(Date:4/30/2015)...   Regulus Therapeutics Inc . (NASDAQ: RGLS ... of innovative medicines targeting microRNAs, today announced that it ... ended March 31, 2015 on Thursday, May 7, 2015, ... Regulus will host a conference call and webcast on ... Time to discuss its first quarter 2015 financial results ...
Breaking Medicine Technology:AcelRx Pharmaceuticals to Participate at Upcoming Investor Conferences in May 2Omnicell Announces First Quarter 2015 Results 2Omnicell Announces First Quarter 2015 Results 3Omnicell Announces First Quarter 2015 Results 4Omnicell Announces First Quarter 2015 Results 5Omnicell Announces First Quarter 2015 Results 6Omnicell Announces First Quarter 2015 Results 7Omnicell Announces First Quarter 2015 Results 8Omnicell Announces First Quarter 2015 Results 9Omnicell Announces First Quarter 2015 Results 10Omnicell Announces First Quarter 2015 Results 11Omnicell Announces First Quarter 2015 Results 12Omnicell Announces First Quarter 2015 Results 13Omnicell Announces First Quarter 2015 Results 14Omnicell Announces First Quarter 2015 Results 15Omnicell Announces First Quarter 2015 Results 16Omnicell Announces First Quarter 2015 Results 17Omnicell Announces First Quarter 2015 Results 18Omnicell Announces First Quarter 2015 Results 19Omnicell Announces First Quarter 2015 Results 20Omnicell Announces First Quarter 2015 Results 21Omnicell Announces First Quarter 2015 Results 22Omnicell Announces First Quarter 2015 Results 23Omnicell Announces First Quarter 2015 Results 24Omnicell Announces First Quarter 2015 Results 25Omnicell Announces First Quarter 2015 Results 26Omnicell Announces First Quarter 2015 Results 27Regulus Announces Timing for First Quarter 2015 Financial Results Webcast and Conference Call 2Regulus Announces Timing for First Quarter 2015 Financial Results Webcast and Conference Call 3
... CITY , Feb. 5 (Nasdaq: WHRT ) ... circulatory systems, announced today that on February 4, 2010 , ... to serve as a director of the Company.  Mr. Jones ... of the Board of Directors. , Mr. Jones began his ...
... , WOODCLIFF LAKE, N.J. , Feb. 5 ... Drug Administration (FDA) issued a complete response letter regarding the ... for the prevention of nausea and vomiting associated with highly- ... an agency-wide restriction on foreign travel in India , ...
Cached Medicine Technology:World Heart Corporation Announces the Election of a New Director 2Strativa Pharmaceuticals Provides An Update On Zuplenz(R) (Ondansetron) Oral Soluble Film 2Strativa Pharmaceuticals Provides An Update On Zuplenz(R) (Ondansetron) Oral Soluble Film 3
(Date:5/2/2015)... ProText Kinetic 2 is a set of ... Pro X. ProText Kinetic 2 features 40 animation ... Pro X . Easily create interactive text videos without ... ProText Kinetic 2. , Using ProText Kinetic is as easy ... Kinetic presets in the FCPX timeline. Playback the default ...
(Date:5/2/2015)... “ Peachtree Audio ” was featured on ... features the latest and coolest technology products available to ... for NewsWatch, conducted the review and shared with viewers ... Music is an important part of people’s lives – ... the royal treatment. Peachtree Audio does just that with ...
(Date:5/2/2015)... TX (PRWEB) May 02, 2015 ... skin laxity issues of the face, neck and ... new concept with real potential for the success ... by the ThermiHealth Clinical Advisory Council, ThermiGyn’s Women’s ... FACOG, FACS, ACGE, concluded that ThermiGyn’s temperature controlled ...
(Date:5/1/2015)... IDLife LLC, a health and wellness ... the addition of its newest partner and fitness celebrity, ... athlete, growing up in gymnastics and competitive diving, but ... a personal trainer and helping others achieve their fitness ... TV shows highlighting her stunning physique and unique training ...
(Date:5/1/2015)... (PRWEB) May 01, 2015 Jusuru International ... for the successful repositioning of its flagship nutritional supplement, ... brand with a new name, new logo, new packaging, ... Ethos Awards are designed to identify and promote programs ... best. , “DSA congratulates Jusuru International for their ...
Breaking Medicine News(10 mins):Health News:Pixel Film Studios Announced the Release of Protext Kinetic 2 for FPCX. 2Health News:Affordable High-End Audio Equipment was Featured on NewsWatch Television 2Health News:Study Demonstrates Efficacy of Temperature Controlled Radiofrequency for Vulvovaginal Laxity 2Health News:Study Demonstrates Efficacy of Temperature Controlled Radiofrequency for Vulvovaginal Laxity 3Health News:IDLife LLC Announces New Partnership with Fitness Celebrity, Jen Widerstrom 2Health News:Jusuru International Receives 2015 DSA Ethos Award 2Health News:Jusuru International Receives 2015 DSA Ethos Award 3Health News:Jusuru International Receives 2015 DSA Ethos Award 4Health News:Jusuru International Receives 2015 DSA Ethos Award 5
... The American Red Cross,announced today that J. ... of,Executive Vice President for the organization,s Biomedical Services., ... largest blood collection,organizations. Each year the American Red ... distributes around 9.5 million blood products to,patients at ...
... ARLINGTON, Va., Jan. 8 The American,Association for ... fraud announced today in another of a series of ... Services (CMS) on the same,subject. The Association continues to ... in the durable medical equipment,(DME) sector. At the same ...
... - Net revenue projected to grow 20 percent in 2008 ... milestones for the DPP-4 ... - EPS expected to grow 36 percent in 2008, ... 2007 guidance and reported its projected,financial guidance for 2008., PPD anticipates that ...
... Use May Be Associated with Reduced Cancer Risk ... be at lower risk for developing cancer, especially lung ... directly prevent cancer. , Laboratory studies have shown that ... observational studies has been inconsistent. , To investigate ...
... carriers , , TUESDAY, Jan. 8 (HealthDay News) -- Not ... show the same risk for developing breast cancer. , ... risk among families carrying the mutations, indicating that the ... factors. , "Risk among carriers varies considerably, and, if ...
... dialysis patients shows that although U.S. residents have the ... their prescription drugs are far less likely to take ... research from the University of Michigan School of Public ... that high out-of-pocket drug costs are only a partial ...
Cached Medicine News:Health News:American Red Cross Announces New Leader for Biomedical Services 2Health News:Medicare Anti-Fraud Measures are Way Overdue, Says Durable Medical Equipment Industry 2Health News:Medicare Anti-Fraud Measures are Way Overdue, Says Durable Medical Equipment Industry 3Health News:PPD Updates 2007 Forecast; Issues Financial Guidance for 2008 2Health News:PPD Updates 2007 Forecast; Issues Financial Guidance for 2008 3Health News:PPD Updates 2007 Forecast; Issues Financial Guidance for 2008 4Health News:PPD Updates 2007 Forecast; Issues Financial Guidance for 2008 5Health News:Other highlights in the Jan. 8 JNCI 2Health News:Other highlights in the Jan. 8 JNCI 3Health News:Other highlights in the Jan. 8 JNCI 4Health News:BRCA Mutations Don't Raise Breast Cancer Risk Equally 2Health News:BRCA Mutations Don't Raise Breast Cancer Risk Equally 3Health News:Americans pay the most for prescription drugs and still don't take them 2
... The RX600 is a versatile, fully ... range of built-in traction facilities, a powered ... make it extremely versatile too. ,<br.,In fact ... general surgery as it is for traction ...
When You Need Optimal Patient Comfort with Minimal Weight at a Nonunion Site...Demand The OrthoPak Noninvasive Bone Growth Stimulator. , ,Most Appropriate for the Proximal Femur, Metatarsal/Tar...
... OrthoVision Orthopedic and Fracture Table is ... It provides flexible, easy to use, ... and reparative orthopedic procedures. Radiolucent abductor ... post provide exceptional imaging capability. OrthoVision ...
... provides a non-invasive therapy for the ... of fresh fracture healing that you ... daily, or as prescribed by your ... fracture to be sufficiently healed to ...
Medicine Products: