|By Marketwired .||
|June 19, 2014 11:49 AM EDT||
SAN RAMON, CA -- (Marketwired) -- 06/19/14 -- SteadyMed Therapeutics Inc., a Specialty Pharmaceutical company focused on the use of its platform technology to develop drug products to treat underserved medical needs in orphan and high value disease states, today announced that the company has entered into an agreement with Bespak Europe Ltd ("Bespak") for the development and manufacture of the device elements of SteadyMed's lead drug product Trevyent.
Trevyent is a late development-stage drug product that uses SteadyMed's PatchPump® to administer treprostinil, to treat the orphan disease Pulmonary Arterial Hypertension. Unlike the current infusion systems used to deliver treprostinil, Trevyent will come to the patient pre-programmed with the correct dose delivery rate and pre-filled with sterile drug in a small, discreet, disposable and water resistant wearable device.
Bespak's Cambridge, UK, based Innovation Team has been working with SteadyMed to develop its novel PatchPump device, for the parenteral delivery of treprostinil. This new agreement between Bespak and SteadyMed provides for the further development of the device and its final commercial manufacturing process. The agreement helps to significantly advance SteadyMed's Trevyent development program for which a New Drug Application is planned to be filed with the U.S. Food and Drug Administration during the second half of 2015.
Jonathan M.N. Rigby, SteadyMed's President and Chief Executive Officer, commented, "As a company rapidly approaching final design for industrialization of our Trevyent product and significant regulatory milestones, it is critical that we select the very best contract manufacturing partners in the industry. That is why we chose Bespak. We are very pleased to be working with them in this partnership."
Keyvan Djamarani, Bespak's Managing Director, commented: "We are delighted to have entered into this agreement with SteadyMed. This collaboration takes Bespak into an interesting therapeutic area and parenteral drug delivery technology, and we are pleased with the latest success of our Innovation Team. This program further strengthens our presence in the growing Injectable therapeutics sector."
SteadyMed Ltd., with offices in San Ramon, CA and Rehovot, Israel, is a private, venture funded Specialty Pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs. These drug products will be approved via the 505(b)(2) regulatory pathway, leading to commercialization by a targeted SteadyMed sales and marketing infrastructure.
Trevyent is not approved for sale by the FDA; it is a development stage drug product that uses SteadyMed's PatchPump to administer treprostinil, a vasodilatory prostacyclin analogue to treat Pulmonary Arterial Hypertension. Unlike the current infusion systems used to deliver treprostinil, Trevyent will come to the patient pre-programmed with the correct dose delivery rate and pre-filled with sterile drug in a small, discreet, disposable and water resistant PatchPump.
PatchPump is not approved for sale by the FDA; it is a novel, compact, prefilled, preprogrammed, disposable, parenteral drug delivery platform.
Bespak, a Consort Medical company, is a leading global supplier of drug delivery devices for injectable and inhaled products. Bespak has contributed to the design, development and industrialization of some of the world's leading medical devices. Headquartered in the UK and with representation in a number of key territories, Bespak employs over 600 people and manufactures more than 500 million medical devices each year, supporting device programs from pilot-scale to commercial supply.
Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=2621881
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
Apr. 27, 2017 12:45 PM EDT Reads: 1,250
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain.
Apr. 27, 2017 12:45 PM EDT Reads: 2,687
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
Apr. 27, 2017 12:30 PM EDT Reads: 1,193
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
Apr. 27, 2017 12:30 PM EDT Reads: 1,005
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTred processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
Apr. 27, 2017 12:30 PM EDT Reads: 2,845
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Apr. 27, 2017 12:15 PM EDT Reads: 1,200
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Apr. 27, 2017 12:15 PM EDT Reads: 3,128
Did you know that you can develop for mainframes in Java? Or that the testing and deployment can be automated across mobile to mainframe? In his session at @DevOpsSummit at 20th Cloud Expo, Vaughn Marshall, Sr. Principal Product Owner at CA Technologies, will discuss and demo how increasingly teams are developing with agile methodologies using modern development environments and automating testing and deployments, mobile to mainframe.
Apr. 27, 2017 12:00 PM EDT Reads: 1,330
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
Apr. 27, 2017 12:00 PM EDT Reads: 1,305
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
Apr. 27, 2017 10:45 AM EDT Reads: 1,252
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Apr. 27, 2017 10:45 AM EDT Reads: 2,198
Apr. 27, 2017 10:15 AM EDT Reads: 2,415
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across supply chain networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost and time for product recall as well as advance trade. Are you curious about Blockchain and how it can provide you with new opportunities for innovation and growth? In her session at 20th Cloud Exp...
Apr. 27, 2017 10:15 AM EDT Reads: 1,967
Cloud promises the agility required by today’s digital businesses. As organizations adopt cloud based infrastructures and services, their IT resources become increasingly dynamic and hybrid in nature. Managing these require modern IT operations and tools. In his session at 20th Cloud Expo, Raj Sundaram, Senior Principal Product Manager at CA Technologies, will discuss how to modernize your IT operations in order to proactively manage your hybrid cloud and IT environments. He will be sharing be...
Apr. 27, 2017 10:00 AM EDT Reads: 645
Back in February of 2017, Andrew Clay Schafer of Pivotal tweeted the following: “seriously tho, the whole software industry is stuck on deployment when we desperately need architecture and telemetry.” Intrigue in a 140 characters. For me, I hear Andrew saying, “we’re jumping to step 5 before we’ve successfully completed steps 1-4.”
Apr. 27, 2017 09:45 AM EDT Reads: 1,824