Boehringer Ingelheim starts clinical study on interchangeability between its adalimumab biosimilar candidate and HUMIRA®
Boehringer Ingelheim announced today that the first patient has been enrolled into its VOLTAIRE-X interchangeability study. The goal of the study is to demonstrate that BI 695501 is interchangeable with the U.S.-marketed formulation of Humira®* 40mg/0.8mL. This is the first study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar candidate.
The study will compare the pharmacokinetics and clinical outcomes between patients receiving Humira® continuously, versus those who switch repeatedly between Humira® and BI 695501, Boehringer Ingelheim’s adalimumab biosimilar candidate.1 The study will also assess safety, immunogenicity and efficacy.1
“We are pleased that the first patient has now been enrolled in VOLTAIRE-X, and look forward to continued recruitment and patient follow-up,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “The initiation of this study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases through biosimilars. With biosimilars, we will have the opportunity to expand treatment options while at the same time providing value to the healthcare system.”
The VOLTAIRE-X study (NCT03210259)1, is being conducted in 240 patients with moderate-to-severe chronic plaque psoriasis. Results from the study are expected in the second half of 2019.1
BI 695501 has been accepted for regulatory review by the European Medicines Agency and the U.S. Food and Drug Administration.2 Phase III results demonstrating clinical equivalence of BI 695501 to Humira® in people living with rheumatoid arthritis were recently presented at the annual European Congress of Rheumatology.3
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
For references and notes to editors, please visit: http://www.boehringer-ingelheim.com/press-release/interchangeability-study-bi-695501-vs-humira
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
AURAK Enters into a Memorandum of Understanding with Al-Farabi Kazakh National University22.7.2018 12:52 | Tiedote
The American University of Ras Al Khaimah (AURAK) President, Professor Hassan Hamdan Al Alkim, and the Al-Farabi Kazakh National University (KazNU) Rector, Professor Galimkair Mutanov, of the Republic of Kazakhstan, signed a Memorandum of Understanding (MoU), agreeing to exchange students, faculty, and research. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180722005025/en/ The Al-Farabi Kazakh National University (KazNU) Rector, Professor Galimkair Mutanov, of the Republic of Kazakhstan and the American University of Ras Al Khaimah (AURAK) President, Professor Hassan Hamdan Al Alkim, exchange a gift to commemorate their universities uniting in an MoU agreement. (Photo: AETOSWire) In the spirit of fostering a close international relationship between the Republic of Kazakhstan and the United Arab Emirates, developing bilateral relations in educational and scientific fields, and wishing to make their own contributions to the
Philip Morris International Announces Non-Executive Board Chairman Louis Camilleri to Assume CEO Role at Ferrari S.p.A.21.7.2018 21:19 | Tiedote
The board of directors of Philip Morris International (NYSE:PM) has its board member, Sergio Marchionne, and his family in our thoughts and prayers during this challenging time. We congratulate our board chairman, Louis Camilleri, as he assumes the role of CEO of Ferrari S.p.A. The long term relationship between our two companies is deep and meaningful and we look forward to continued business collaboration. Mr. Camilleri will continue to serve as non-executive chairman of the PMI board. Philip Morris International: Who We Are We are a leading international tobacco company engaged in the manufacture and sale of cigarettes and other nicotine-containing products in markets outside the United States of America. We’re building our future on smoke-free products. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, we aim to ensure that our smoke-free products meet adult consumer preferences and rigorous regulatory requirem
Loxam Announces a Conditional Agreement to Acquire UK Platforms20.7.2018 17:51 | Tiedote
Loxam Group (“Loxam”) announces that its wholly-owned subsidiary Nationwide Platforms Limited (“Nationwide”) has entered into a conditional agreement with HSS Hire Group plc (“HSS”) with respect to the acquisition of UK Platforms Limited (“UKP”). UKP specializes in renting powered access equipment from its 12 branches located throughout the United Kingdom. The company has approximately 130 employees and operates a fleet of 3,000 units. UKP is controlled by HSS since 2013. As part of this transaction, Nationwide has entered into a commercial agreement with HSS to provide powered access equipment to complement HSS’ existing fleet. The closing of the transaction is subject to the approval by HSS’ shareholders and the confirmation that it will not be referred to the Competition and Mergers Authority. The transaction is expected to close before year end 2018. Don Kenny, CEO of Loxam’s Powered Access Division states: “I am delighted with the acquisition of UKP which will further reinforce NW
Schlumberger Announces Second-Quarter 2018 Results20.7.2018 14:00 | Tiedote
Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2018 Mar. 31, 2018 Jun. 30, 2017 Sequential Year-on-year Revenue $8,303 $7,829 $7,462 6% 11% Pretax operating income $1,094 $974 $950 12% 15% Pretax operating margin 13.2% 12.4% 12.7% 75 bps 45 bps Net income - GAAP basis $430 $525 $(74) -18% n/m Net income, excluding charges & credits* $594 $525 $488 13% 22% Diluted EPS - GAAP basis $0.31 $0.38 $(0.05) -18% n/m Diluted EPS, excluding charges & credits* $0.43 $0.38 $0.35 13% 23% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “The second quarter was both busy and exciting for Schlumberger as we completed a number of major milestones in preparation for the broad-based global activity upturn that is now emerging. We delivered solid top-line gro
H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 22:50 | Tiedote
H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&
SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 19:01 | Tiedote
We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact email@example.com . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough firstname.lastname@example.org
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme