text:
|By PR Newswire
Article Rating:
|January 10, 2014 07:00 AM EST
GLENDALE, Wis., Jan. 10, 2014 /PRNewswire/ -- Crealta Pharmaceuticals LLC ("Crealta"), a new specialty pharmaceutical company, announced today the completion of the acquisition of substantially all of the assets of Savient Pharmaceuticals, Inc. ("Savient"). Crealta previously announced the winning of an auction for these assets, the signing of a definitive acquisition agreement with Savient, and the subsequent approval of the transaction by the U.S. Bankruptcy Court for the District of Delaware.
The key asset acquired by Crealta is KRYSTEXXA (pegloticase), a novel biologic product that was approved by the FDA in 2010. KRYSTEXXA is a PEGylated uric acid specific enzyme, or uricase, that has been shown to statistically significantly reduce uric acid levels for many patients with refractory chronic gout.
"We are tremendously excited to have completed the transaction, and more importantly, to ensure the continued availability of this critical product," commented Ed Fiorentino, Chairman and CEO of Crealta. "Crealta is committed to providing outstanding support and service to healthcare professionals and the patients that they serve with refractory chronic gout."
Crealta was established in August 2013 in partnership with GTCR, one of the nation's leading private equity firms.
The following information is provided in both the U.S. and European prescribing information.
KRYSTEXXA is not indicated for the treatment of asymptomatic hyperuricemia. KRYSTEXXA is indicated for adults who have tried or cannot take oral gout medications and still have high uric acid levels and signs and symptoms of gout. Patients who have a genetic condition known as G6PD deficiency should not use KRYSTEXXA.
Discontinue oral urate-lowering therapies before instituting KRYSTEXXA and do not institute oral urate-lowering therapy while the patient is on KRYSTEXXA therapy.
Warnings and Precautions:
- Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be pre-medicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
- Infusion reactions which occurred in some patients treated with KRYSTEXXA. The risk of an infusion reaction is higher in patients who have lost therapeutic response. Because the risk of infusion reactions is higher in patients who lose therapeutic response to KRYSTEXXA, monitor serum uric acid before each infusion and discontinue treatment if levels rise above 6mg/dL, particularly when two consecutive levels above 6 mg/dL are observed.
- An increase in gout flares was seen in some patients treated with KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.
KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion.
Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully.
In addition, the European Summary of Product Characteristics (SmPC) includes two other special warnings and precautions for use.
- If hemolysis and/or methemoglobinemia occur in patients receiving KRYSTEXXA, treatment should be immediately and permanently discontinued and appropriate measures initiated.
- Patients over 100 kg body weight may have higher titers of anti-pegloticase antibodies and infusion-related reactions showed a tendency to occur in a greater proportion of patients in this weight group.
The most commonly reported serious adverse reactions were anaphylaxis, infusion reactions and gout flares. The SmPC includes the following very common adverse reactions: gout flares, infusion reactions, nausea, dermatitis, urticaria, pruritus, skin irritation and dry skin. In the U.S. prescribing information, the most common adverse reactions (5% or greater) reported were gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.
Please see full prescribing information for KRYSTEXXA.
About Refractory Chronic Gout (RCG)
Symptoms of gout are caused by the body's response to the presence of high uric acid (urate) levels which can lead to the formation of urate crystals in the joints and surrounding tissue, which form when uric acid levels in the blood are elevated (a condition called hyperuricemia). The longer hyperuricemia persists, the higher the risk of developing gout. Symptoms of gout may include painful flares, pain or swelling in the joints (known as "gouty arthritis") or deposits of urate crystals under the skin, called "tophi." Although most cases of gout can be controlled with conventional urate-lowering therapy, uric acid levels may remain high and symptoms persist despite treatment efforts, even at maximum medically appropriate doses of conventional therapies.
RCG is a chronic disease that, if left untreated, can lead to chronic pain, tophi-induced joint destruction and disfigurement, and significant mobility restrictions for patients. RCG has been granted orphan drug status by the FDA due to the relatively small patient population afflicted with this debilitating condition.
About Crealta
Crealta is a specialty pharmaceutical company focused on innovative therapeutics designed to improve patient outcomes. The company was formed to acquire, develop, and market specialty pharmaceutical products with a focus on select physician specialties. For more information about Crealta, please visit www.crealtapharma.com, call 1-781-639-1910, or email [email protected].
About GTCR
Founded in 1980, GTCR is a leading private equity firm focused on investing in growth companies in the Financial Services & Technology, Healthcare and Information Services & Technology industries. The Chicago-based firm pioneered The Leaders Strategy™ – finding and partnering with management leaders in core domains to identify, acquire and build market-leading companies through transformational acquisitions and organic growth. Since its inception, GTCR has invested more than $10 billion in over 200 companies. For more information, please visit www.gtcr.com.
SOURCE Crealta Pharmaceuticals LLC
Cloud applications are seeing a deluge of requests to support the exploding advanced analytics market. "Open analytics" is the emerging strategy to deliver that data through an open data access layer, in the cloud, to be directly consumed by external analytics tools and popular programming languages. An increasing number of data engineers and data scientists use a variety of platforms and advanced analytics languages such as SAS, R, Python and Java, as well as frameworks such as Hadoop and Spark...
May. 30, 2017 02:15 AM EDT Reads: 911
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 bes...
May. 30, 2017 12:30 AM EDT Reads: 3,930
Everywhere we turn in our industry we can find strong opinions about the direction, type and nature of cloud's impact on computing and business. Another word that is used in every context in our industry is "hybrid." In his session at 20th Cloud Expo, Alvaro Gonzalez, Director of Technical, Partner and Field Marketing at Peak 10, will use a combination of a few conceptual props and some research recently commissioned by Peak 10 to offer a real-world consideration of how the various categories of...
May. 29, 2017 11:30 PM EDT Reads: 1,402
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...
May. 29, 2017 11:15 PM EDT Reads: 4,043
Most DevOps journeys involve several phases of maturity. Research shows that the inflection point where organizations begin to see maximum value is when they implement tight integration deploying their code to their infrastructure. Success at this level is the last barrier to at-will deployment. Storage, for instance, is more capable than where we read and write data. In his session at @DevOpsSummit at 20th Cloud Expo, Josh Atwell, a Developer Advocate for NetApp, will discuss the role and value...
May. 29, 2017 11:00 PM EDT Reads: 1,425
SYS-CON Events announced today that Outscale, a global pure play Infrastructure as a Service provider and strategic partner of Dassault Systèmes, 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. Founded in 2010, Outscale simplifies infrastructure complexities and boosts the business agility of its customers. Outscale delivers a secure, reliable and industrial strength solution for its customers, which in...
May. 29, 2017 10:45 PM EDT Reads: 1,045
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, 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. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers' changing business needs, enabling them to lower costs, improve performance and focus intern...
May. 29, 2017 10:30 PM EDT Reads: 6,478
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company's latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
May. 29, 2017 10:30 PM EDT Reads: 6,356
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
May. 29, 2017 10:15 PM EDT Reads: 5,598
In order to meet the rapidly changing demands of today's customers, companies are continually forced to redefine their business strategies in order to meet these needs, stay relevant and continue to see profitable growth. IoT deployment and development is integral in this transformation, and today businesses are increasingly seeing the value of investing their resources into IoT deployments. These technologies are able increase ROI through projects such as connecting supply chains or enabling sm...
May. 29, 2017 10:00 PM EDT Reads: 951
Regardless of what business you're in, it's increasingly a software-driven business. Consumers' rising expectations for connected digital and physical experiences are driving what some are calling the "Customer Experience Challenge." In his session at @DevOpsSummit at 20th Cloud Expo, Marco Morales, Director of Global Solutions at CollabNet, will discuss how organizations are increasingly adopting a discipline of Value Stream Mapping to ensure that the software they are producing is poised to o...
May. 29, 2017 09:15 PM EDT Reads: 980
This talk centers around how to automate best practices in a multi-/hybrid-cloud world based on our work with customers like GE, Discovery Communications and Fannie Mae. Today's enterprises are reaping the benefits of cloud computing, but also discovering many risks and challenges. In the age of DevOps and the decentralization of IT, it's easy to over-provision resources, forget that instances are running, or unintentionally expose vulnerabilities.
May. 29, 2017 08:45 PM EDT Reads: 1,578
In his opening keynote at 20th Cloud Expo, Michael Maximilien, Research Scientist, Architect, and Engineer at IBM, will motivate why realizing the full potential of the cloud and social data requires artificial intelligence. By mixing Cloud Foundry and the rich set of Watson services, IBM's Bluemix is the best cloud operating system for enterprises today, providing rapid development and deployment of applications that can take advantage of the rich catalog of Watson services to help drive insigh...
May. 29, 2017 08:30 PM EDT Reads: 1,109
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.
May. 29, 2017 07:30 PM EDT Reads: 7,917
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, 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. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...
May. 29, 2017 07:30 PM EDT Reads: 2,580


text:
@TheMichaelRock: Do women know that it's perfectly legal to apply makeup at home before they get in their car?
@gruffybeard: 9: Daddy, wanna hear something cool? Me: Sure! 9: *tells story* Me: Ok, well clearly we need to work on how you define "something cool".
@miliondollameat: me: wow the stars are beautiful gf: omg babe they really are me: u know who else is beautiful? gf: *blushes* who? :3 me: Harambe
@SadieSkyNinja: Nothing confuses me more than a straight up street thug with braces.
@Reverend_Scott: When I lift one of my dog's muddy paws to clean it he acts like he's gonna fall down. DOG YOU STILL GOT 3 LEGS. I ONLY GOT 2
@UncleDuke1969: "Your keys are over THERE." - Wow. You have eagle eyes! "Yup. My vision is 20/20." - No. I mean they're small, beady & kinda close together.

subset: commoncrawl


text:
New Study Reveals Worrying Trends in Underage Marriage in Indonesia
February 15, 2012
Aisyiyah, the women's wing of Muhammadiyah, recently released results of a study it did on adolescent sexuality in Yogyakarta's Bantul district. Pointing to the widespread practice of girls marrying in their teens and even below the legal age of 16, the study makes for a worrying read.
The research, conducted through questionnaires distributed to 717 students aged 14 to 21 at various schools in Bantul and followed up with focus group discussions (FGD), indicates that adolescents have very little knowledge about their bodies and their sexuality, and that this correlates with a high rate of underage marriages.
The research also shows that many young people remain strongly attached to a variety of reproductive health myths. These are related to such phenomena as menstruation, but also to pregnancy and its prevention.
Data from the Banguntapan, Dlingo and Kasihan sub-districts shows high rates of both marriage and pregnancies below the age of 20. The level of young marriages in Bantul can also be seen from the large number of "dispensations" issued by the Bantul Religious Court to grant permission for such marriages. Although the age requirements set out in the Marriage Law are violated, the dispensations are unavoidable because these young couples will need marriage certificates to arrange their children's birth certificates.
In the Dlingo sub-district, most of the FGD participants had not received any formal information about reproduction. What little they did know, they had learned from friends or the internet.
According to data collected by Aisyiyah from the Bantul Religious Court, there were only ten requests for such age dispensations in 2000, but 115 such cases in 2010. While this could suggest increased public awareness of the importance of documentation of marriages, the facts on the ground still indicate a high number of underage marriages. FGDs with adolescents in Kasihan and Dlingo revealed several reasons why many marry young.
Some cited a desire to reduce the financial burden on parents, fear of becoming an "old maid" and the myth of loss of virginity through repeated menstruation. The No. 1 reason cited, however, was unwanted pregnancy.
In any case, the research underlines that unwanted pregnancies occur due to youngsters' – and their parents' – lack of proper knowledge about sexual and reproductive health. Another FGD, with religious court judges and Religious Affairs Office (KUA) officials in Bantul, found many reasons why it was difficult for KUA officers to prevent underage marriages.
These include poverty, and the desire of farming communities to have an additional source of unpaid labor; traditional attitudes such as concerns that one's daughter may become an old maid; the lack of outreach by village and sub-district officials to promote a later age of marriage, and lack of funding for such outreach efforts; and geographical factors making it difficult for KUA officials to meet in person with the prospective bride when couples register for marriage.
It is pointless simply to complain about the situation, or for the parties concerned to blame one another. What is needed, clearly, is education. The new data proves once again what health activists have long been shouting: that education on reproductive health is essential.
Though some people still reject this idea, claiming it would be tantamount to teaching young people how to have sex, the only way to prevent unwanted pregnancies, and consequently underage marriages, is to provide accurate, appropriate information about sexuality. Based on Islamic jurisprudence, this can in fact be categorized as an emergency situation: it is far better to choose the path of the lesser adverse impact.
Other concrete steps would be to increase local government budgets for the dissemination of information or to expand counseling institutions for adolescents, and not just in major cities. Perhaps (female) KUA administrative personnel or village officials could be encouraged to serve as reproductive health counselors for young people.
Finally, we need to end discrimination in medical family-planning services, which currently are only accessible to married couples. This may be a controversial proposal for some, but it is unavoidable. Our young people are being led astray by misleading information about sex, with disastrous consequences.
This article was first published in the Jakarta Globe on February 8, 2012.
Lies Marcoes is a senior program officer at The Asia Foundation in Indonesia. She can be reached at email@example.com. The views and opinions expressed here are those of the individual author and not those of The Asia Foundation.
0 Comments
Submit a Comment
About our blog, In AsiaIn Asia is a weekly in-depth, in-country resource for readers who want to stay abreast of significant events and issues shaping Asia\'s development, hosted by The Asia Foundation. Drawing on the first-hand insight of over 70 renowned experts in over 20 countries, In Asia delivers concentrated analysis on issues affecting each region of Asia, as well as Foundation-produced reports and polls.
In Asia is posted and distributed every Wednesday evening, Pacific Time and is accessible via email and RSS. If you have any questions, please send an email to firstname.lastname@example.com.
ContactFor questions about In Asia, or for our cross-post and re-use policy, please send an email to email@example.com.
The Asia Foundation
465 California St., 9th Floor
San Francisco, CA 94104
Mailing Address:
PO Box 193223
San Francisco, CA 94119-3223
Dr. Richard Haass and Ambassador Kathleen Stephens Address The Asia Foundation at New York Board Meeting
New York
May 24, 2017
Airport Congestion in the Philippines Sees Improvements
May 24, 2017
Asia Foundation Experts Participate in ADB Yokohama 2017 Annual Meeting
May 17, 2017
Asia Foundation Hosts APEC App Challenge to Help the Asia-Pacific Region's Small Businesses Expand
May 16, 2017
Cambodia's Online Reform Initiative Inventory
Phnom Penh
Program Snapshot
Asia Foundation Releases Report on Disaster Preparedness During Political Transition in Nepal
April 24, 2017


text:
From Wikipedia, the free encyclopedia
Tsintsadze (Georgian: ცინცაძე) is a Noble family. Notable people with the surname include:
- Dito Tsintsadze (born 1957), Georgian film director and screenwriter
- Giorgi Tsintsadze (born 1986), Georgian basketball player
- Irakli Tsintsadze (born 1964), Georgian composer
- Kalistrate Tsintsadze (Callistratus of Georgia; 1866–1952), Catholicos-Patriarch of All Georgia
- Kote Tsintsadze (1887–1930), Georgian communist politician
- Sulkhan Tsintsadze (1925–1991), Georgian composer
|Wikimedia Commons has media related to Tsintsadze.
|This page lists people with the surname Tsintsadze. If an internal link intending to refer to a specific person led you to this page, you may wish to change that link by adding the person's given name(s) to the link.