|
News Feed Item
Galapagos opens IND for GLPG0634 in the US
|
By Marketwired . |
Article Rating: |
|
December 3, 2012 01:51 AM EST |
Reads: |
443 |
MECHELEN, BELGIUM -- (Marketwire) -- 12/03/12 -- Galapagos NV (EURONEXT BRUSSELS: GLPG)
announced
today that it has opened its Investigational New Drug application for
GLPG0634
with the US Food and Drug Administration.
Galapagos intends to conduct a Phase 1 drug interaction study in the
United
States, which is expected to be completed in the first quarter of
2013.
Acceptance of the IND was based on a review by the FDA of the GLPG0634
data
package, including chemical/pharmaceutical data, preclinical data up
to the
formal 13-week toxicology studies and currently completed clinical studies.
"This is an important step in our clinical development plan for GLPG0634,"
said
Piet Wigerinck, CSO of Galapagos. "The FDA has reviewed all
the GLPG0634 pre-clinical and clinical data to date and found these
supportive of the conduct of
our first clinical trial within the United States. We will follow up
with
studies in rheumatoid arthritis patients next year, and intend to
include US
study centers in our Phase 2b program."
About Investigational New Drug (IND) Application
United States Federal law requires a pharmaceutical company to
obtain an
exemption to ship an experimental drug across state lines, usually to
clinical
investigators, before a marketing application for the drug has been
approved.
The IND is the means by which the sponsor technically obtains this
exemption.
The FDA reviews the IND for safety to assure that research subjects will
not be
subjected to unreasonable risk. The IND application contains
information in
three broad areas: animal pharmacology and toxicology studies,
clinical
protocols and investigator information, and manufacturing information.
About Galapagos
Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is a mid-size
clinical stage biotechnology company specialized in the discovery and
development of small molecule and antibody therapies with
novel modes-of-action. The Company is progressing its JAK1 inhibitor
GLPG0634, as well as one of the largest pipelines
in biotech, with four programs in development and over 30 discovery
programs.
The Galapagos Group has over 800 employees and operates facilities
in six
countries, with global headquarters in Mechelen, Belgium. More
info at:
www.glpg.com
This release may contain forward-looking statements, including,
without
limitation, statements containing the words "believes,"
"anticipates,"
"expects," "intends," "plans," "seeks," "estimates," "may," "will,"
"could,"
"stands to," and "continues," as well as similar
expressions. Such forward-looking statements may involve known and
unknown risks, uncertainties and other
factors which might cause the actual results, financial condition,
performance
or achievements of Galapagos, or industry results, to be materially
different
from any historic or future results, financial conditions,
performance or
achievements expressed or implied by such forward-looking statements.
Given
these uncertainties, the reader is advised not to place any undue
reliance on
such forward-looking statements. These forward-looking statements speak
only as
of the date of publication of this document. Galapagos expressly
disclaims any
obligation to update any such forward-looking statements in this
document to
reflect any change in its expectations with regard thereto or any
change in
events, conditions or circumstances on which any such statement is based,
unless
required by law or regulation.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Galapagos NV via Thomson Reuters ONE
[HUG#1661929]
Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.
Latest Stories By Liz McMillan  The taxi industry never saw Uber coming. Startups are a threat to incumbents like never before, and a major enabler for startups is that they are instantly “cloud ready.” If innovation moves at the pace of IT, then your company is in trouble. Why? Because your data center will not keep up with frenetic pace AWS, Microsoft and Google are rolling out new capabilities. In his session at 20th Cloud Expo, Don Browning, VP of Cloud Architecture at Turner, posited that disruption is inevitable for comp... Apr. 25, 2018 10:45 AM EDT Reads: 5,691 | By Yeshim Deniz  DXWorldEXPO LLC announced today that ICC-USA, a computer systems integrator and server manufacturing company focused on developing products and product appliances, will exhibit at the 22nd International CloudEXPO | DXWorldEXPO.
DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City.
ICC is a computer systems integrator and server manufacturing company focused on developing products and product appliances to meet a wide range of ... Apr. 25, 2018 10:45 AM EDT Reads: 1,175 | By Pat Romanski  In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m... Apr. 25, 2018 10:30 AM EDT Reads: 1,771 | By Elizabeth White  The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar... Apr. 25, 2018 10:15 AM EDT Reads: 4,317 | By Yeshim Deniz  Sanjeev Sharma Joins November 11-13, 2018 @DevOpsSummit at @CloudEXPO New York Faculty. Sanjeev Sharma is an internationally known DevOps and Cloud Transformation thought leader, technology executive, and author. Sanjeev's industry experience includes tenures as CTO, Technical Sales leader, and Cloud Architect leader. As an IBM Distinguished Engineer, Sanjeev is recognized at the highest levels of IBM's core of technical leaders. Apr. 25, 2018 10:15 AM EDT Reads: 2,731 | By Pat Romanski  Headquartered in Plainsboro, NJ, Synametrics Technologies has provided IT professionals and computer systems developers since 1997. Based on the success of their initial product offerings (WinSQL and DeltaCopy), the company continues to create and hone innovative products that help its customers get more from their computer applications, databases and infrastructure. To date, over one million users around the world have chosen Synametrics solutions to help power their accelerated business or per... Apr. 25, 2018 10:00 AM EDT Reads: 2,358 | By Elizabeth White  One of the biggest challenges with adopting a DevOps mentality is: new applications are easily adapted to cloud-native, microservice-based, or containerized architectures - they can be built for them - but old applications need complex refactoring. On the other hand, these new technologies can require relearning or adapting new, oftentimes more complex, methodologies and tools to be ready for production.
In his general session at @DevOpsSummit at 20th Cloud Expo, Chris Brown, Solutions Marketi... Apr. 25, 2018 09:45 AM EDT Reads: 1,206 | By Yeshim Deniz  At the keynote this morning we spoke about the value proposition of Nutanix, of having a DevOps culture and a mindset, and the business outcomes of achieving agility and scale, which everybody here is trying to accomplish," noted Mark Lavi, DevOps Solution Architect at Nutanix, in this SYS-CON.tv interview at @DevOpsSummit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY. Apr. 25, 2018 09:45 AM EDT Reads: 1,182 | By Yeshim Deniz  We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ... Apr. 25, 2018 09:30 AM EDT Reads: 1,712 | By Liz McMillan  Bill Schmarzo, author of "Big Data: Understanding How Data Powers Big Business" and "Big Data MBA: Driving Business Strategies with Data Science," is responsible for setting the strategy and defining the Big Data service offerings and capabilities for EMC Global Services Big Data Practice. As the CTO for the Big Data Practice, he is responsible for working with organizations to help them identify where and how to start their big data journeys. He's written several white papers, is an avid blogge... Apr. 25, 2018 09:30 AM EDT Reads: 2,212 | By Liz McMillan  HyperConvergence came to market with the objective of being simple, flexible and to help drive down operating expenses. It reduced the footprint by bundling the compute/storage/network into one box. This brought a new set of challenges as the HyperConverged vendors are very focused on their own proprietary building blocks. If you want to scale in a certain way, let's say you identified a need for more storage and want to add a device that is not sold by the HyperConverged vendor, forget about it... Apr. 25, 2018 09:30 AM EDT Reads: 5,680 | By Liz McMillan  Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ... Apr. 25, 2018 09:00 AM EDT Reads: 5,587 | By Yeshim Deniz  DXWorldEXPO LLC, the producer of the world's most influential technology conferences and trade shows has announced the 22nd International CloudEXPO | DXWorldEXPO "Early Bird Registration" is now open. Register for Full Conference "Gold Pass" ▸ Here (Expo Hall ▸ Here) Apr. 25, 2018 08:30 AM EDT Reads: 469 | By Liz McMillan  As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? Apr. 25, 2018 08:30 AM EDT Reads: 1,564 | By Liz McMillan  Evan Kirstel is an internationally recognized thought leader and social media influencer in IoT (#1 in 2017), Cloud, Data Security (2016), Health Tech (#9 in 2017), Digital Health (#6 in 2016), B2B Marketing (#5 in 2015), AI, Smart Home, Digital (2017), IIoT (#1 in 2017) and Telecom/Wireless/5G. His connections are a "Who's Who" in these technologies, He is in the top 10 most mentioned/re-tweeted by CMOs and CIOs (2016) and have been recently named 5th most influential B2B marketeer in the US. H... Apr. 25, 2018 08:00 AM EDT Reads: 2,927 |
|
|
|
|
|
|