Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 244

Archive for 6 febbraio 2019

Waddell & Reed, Inc. Boosts Technology Platform

Posted by fidest press agency su mercoledì, 6 febbraio 2019

As it advances initiatives to build a stronger technology platform for its affiliated advisors, Waddell & Reed, Inc. recently signed an agreement with Refinitiv (formerly the Financial and Risk business of Thomson Reuters) to deploy the Thomson ONE advisor desktop solution as the first of many steps toward streamlining advisors’ experience and technology access.Thomson ONE is an industry-leading application that will connect through one desktop solution several of the firm’s existing financial services technology partners – including Albridge Solutions, eMoney, Envestnet and Pershing NetX360 – along with new providers that the firm anticipates announcing later this year.“Adding Thomson ONE is an important step for our advisors, as it creates the hub that brings all of our data and tools together in a desktop workspace,” said Shawn Mihal, president of Waddell & Reed, Inc. “It provides easy, single-sign-on access, simplifies technology connectivity, integrates client data in one place and allows advisors to focus on what they do best: managing client relationships and building their practice.” Mihal noted that this is the first of many steps in the strategic evolution of the Waddell & Reed broker-dealer, as announced in November, collectively focused on technological enhancements, product expansion and broadening advisor support as the firm moves toward an industry-standard model. The broker-dealer is one of the pioneers of the planning industry, founded more than 80 years ago, and today is a subsidiary of parent firm Waddell & Reed Financial, Inc. (NYSE:WDR).“Improving the advisor experience and delivering seamless integration across multiple applications has become a growing challenge for many firms,” said Marika Vilen, global head of Advisor Solutions at Refinitiv. “We are very excited to partner with Waddell & Reed to help improve advisor productivity and provide their advisors with our industry-leading desktop solution. Combined with Waddell & Reed’s technology partners, we look forward to helping advisors provide greater insights to their client relationships as well as enhance recruitment and retention for Waddell & Reed.”
Ultimately, the deployment of Thomson ONE not only brings access to a range of data and services — including client, product, processing, even compensation – but also is scalable, allowing the capture of added applications in the future.

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Chugai’s Hemlibra® Gains Positive CHMP Opinion in Severe Hemophilia A Without Inhibitors

Posted by fidest press agency su mercoledì, 6 febbraio 2019

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that Roche has received notification that the EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Hemlibra®, a treatment for hemophilia A created by Chugai, for routine prophylaxis of bleeding episodes in adults and children with severe hemophilia A without factor VIII inhibitors, administered once weekly, every two weeks, or every four weeks. The CHMP has also adopted a positive opinion for additional dosing options of every two weeks or every four weeks in adults and children with hemophilia A with factor VIII inhibitors.
“We are thrilled that Hemlibra is expected to be approved shortly for people with severe hemophilia A without inhibitors in the Europe Union (EU). Also, I’m very pleased that people in the EU with hemophilia A will soon be offered multiple options of Hemlibra’s dosing interval regardless of their inhibitor expression,” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Osamu Okuda. “Hemlibra is co-promoted by Chugai and Roche in Germany, France, and the United Kingdom, as is the case with the anti-rheumatic agent RoActemra®. We are committed to pursue our efforts in collaboration with Roche so that Hemlibra may further contribute to the treatment of hemophilia A.”
This positive opinion is based on results from two Phase III studies HAVEN 3 (NCT02847637) and HAVEN 4 (NCT03020160), conducted jointly with Roche and Genentech. HAVEN 3 study was conducted to evaluate the reduction of bleed rate of Hemlibra subcutaneous injection once a week and once every two weeks in people with hemophilia A (12 years of age or older) without inhibitors to factor VIII. HAVEN 4 study was conducted to evaluate efficacy, safety, and pharmacokinetics of Hemlibra subcutaneous injection every four weeks in people with hemophilia A (12 years of age or older), with and without inhibitors to factor VIII.
In Japan, Chugai obtained regulatory approval for Hemlibra from the Ministry of Health, Labour and Welfare in December 2018 for an additional indication of prophylactic treatment for people with hemophilia A without inhibitors to factor VIII, as well as for additional dosage and administration as a biweekly or every four-week treatment for people with hemophilia A with inhibitors to factor VIII.

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Senseonics Announces Extension of Distribution Agreement with Roche Diabetes Care

Posted by fidest press agency su mercoledì, 6 febbraio 2019

Senseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced an extension of its distribution agreement with Roche Diabetes Care. As extended, the agreement now runs through January 31, 2021. Under terms of the extended agreement, Roche will continue its role as Senseonics exclusive distributor in Europe, the Middle East and Africa, excluding Scandinavia and Israel. In addition, the agreement has been expanded to provide Roche with exclusive distribution rights in 17 additional countries, including Brazil, Russia, India and China, as well as select markets in the Asia Pacific and Latin American regions.Senseonics also announced preliminary revenue results for fourth quarter and full year 2018. Unaudited preliminary revenue is expected to be $8.0 million for the fourth quarter of 2018 and $19.7 million for the full year 2018, compared to $2.9 million for the fourth quarter of 2017 and $6.4 million for the full year 2017. As of December 31, 2018, cash and cash equivalents were $136.8 million and outstanding indebtedness was $67.7 million.
“We are excited about the ongoing and incremental commitment from Roche, both from a geographic expansion and volume perspective. We believe that the positive reception that the Eversense® CGM System has received in Europe is validation that patients and clinicians are experiencing the transformative power of a long-term CGM system. We look forward to our expanded relationship with Roche in which we have made market expansion, with access and volume in existing and new countries, a strategic priority,” said Tim Goodnow, President and Chief Executive Officer.Mr. Goodnow continued, “We are also pleased with our fourth quarter and full year revenue results. In 2018 we achieved several significant accomplishments including the launch of Eversense in the U.S. and the extended life Eversense® XL system in Europe. The U.S. launch is progressing along with our expectations – feedback from patients has been encouraging, and we are more inspired now than ever about the potential life-enhancing benefits this product offers people with diabetes.”

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