Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for ZINBRYTA® (daclizumab) for Relapsing Multiple Sclerosis
Biogen (Nasdaq:BIIB) and AbbVie (NYSE:ABBV) today announced the voluntary worldwide withdrawal of ZINBRYTA for relapsing multiple sclerosis. The companies believe that characterizing the complex and evolving benefit/risk profile of ZINBRYTA will not be possible going forward given the limited number of patients being treated.
This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180302005168/en/
“Biogen believes the voluntary worldwide withdrawal of ZINBRYTA, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.”
Biogen will continue to work collaboratively with regulatory authorities in the withdrawal of product and with healthcare providers worldwide in their support of ZINBRYTA patients.
Patients currently treated with ZINBRYTA should contact their healthcare provider if they have any questions or concerns.
ZINBRYTA (daclizumab) is currently available in the EU, U.S., Switzerland, Canada and Australia. ZINBRYTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, ZINBRYTA is generally used in people who have tried two or more MS medicines that have not worked well enough. It is not known if ZINBRYTA is safe and effective for use in children under 18 years of age.
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978 as one of the world’s first global biotechnology companies by Charles Weissman, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, today Biogen has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics. We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube .
Biogen Safe Harbor
This press release contains forward-looking statements, including statements relating to the potential benefits, safety, and efficacy of ZINBRYTA, our strategy and plans, and our future expenses and other financial and operating results. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,” “may,” “plan,” “potential,” “possible,” “will,” and similar expressions, and are based on our current beliefs and expectations. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: the occurrence of adverse safety events; restrictions on use of our products or product liability claims; risks of unexpected costs or delays; the estimates and assumptions we make in preparing our financial statements; and the other risks and uncertainties that are described in the Risk Factors section of Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release, and we assume no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise.
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.
AbbVie Forward-Looking Statement
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
BIOGEN MEDIA CONTACT:
David Caouette, +1 781-464-3260
BIOGEN INVESTOR CONTACT:
Matt Calistri, +1 781-464-2442
ABBVIE MEDIA CONTACTS:
Jack Hirschfield, 224-458-0943
Markeisha Marshall, 224-501-4425
ABBVIE INVESTOR CONTACT:
Liz Shea, 847-935-2211
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
GCEL Releases G20 Nations Case Study Involving 90 Ministries, NGOs & IGOs Defining the Guidelines for the Digital Economy Era23.5.2018 21:34 | Tiedote
GCEL, INSME, BVMW and CONFAPI executed a strategic agreement at the European Union Parliament to deploy the Digital Economy Platform (DEP) through GCEL’s HumaWealth Program that digitizes the USD 140 trillion B2B marketplace. These agreements will implement the newly released G20 Nations Case Study recommendations providing the roadmap to reduce annual domestic and international trade costs by USD 3.7 trillion, increase trade by USD 7.7 trillion, create a USD 1 trillion SME fund and generate 300 million manufacturing, agricultural and service industry jobs by 2030. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523006259/en/ GCEL, INSME, BVMW and CONFAPI executed a strategic agreement at the European Union Parliament to deploy the Digital Economy Platform in collaboration with the world's leading technology firms to digitize the USD 140 trillion B2B marketplace (Photo: Business Wire) The agreement was signed by Captain Sa
LTI Q4 USD Revenue Growth up 5.3% QoQ and 21.6% YoY; FY18 Revenues of USD1.13bn, up 16.7%; Digital Revenues Grow 42% in FY1823.5.2018 18:04 | Tiedote
Larsen & Toubro Infotech (BSE: 540005, NSE: LTI), a global technology consulting and digital solutions company, announced its Q4 FY18 and full year FY18 results today. Q4 FY 18 In US Dollars: Revenue at USD 309.0 million; growth of 5.3% QoQ and 21.6% YoY Constant Currency Revenue growth of 4.5% QoQ and 18.7% YoY In Indian Rupees: Revenue at Rs 20,012 million; growth at 6.2% QoQ and 19.3% YoY Net Income at Rs 2,894 million; Net Income growth at 2.3% QoQ and 13.7% YoY Full year FY18 In US Dollars: Revenue at USD 1,132.3 million; growth of 16.7% YoY Constant Currency Revenue growth of 14.7% YoY In Indian Rupees: Revenue at Rs 73,065 million; growth at 12.4% YoY Net Income at Rs 11,124 million; Net Income growth at 14.6% YoY “Our outstanding growth of 5.3% QoQ in Q4 is a result of a broad-based performance across all verticals. We have delivered an industry leading growth of 16.7% for the full financial year with digital revenues up 42% YoY. Our sustained investments in exponential technol
Zebra Medical Vision Announces CE Approval of its Seventh AI Imaging Algorithm - Mammography Lesion Detection23.5.2018 18:00 | Tiedote
Zebra Medical Vision (http://zebra-med.com/) announces today the CE regulatory approval of its newest algorithm to be included in its growing Deep Learning Imaging Analytics platform. The algorithm, capable of detecting suspected malignant lesions in Mammography scans - is the latest addition to other automated tools announced in the past as part of it’s “All-In-One” AI1 business model, among them algorithms that automatically detect brain bleeds, vertebral fractures, coronary artery disease, osteoporosis and more. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523005843/en/ Credit: Zebra Medical Vision According to the American Cancer Society, breast cancer makes up 25% of all new cancer diagnoses in women globally - with nearly 1.7 million women being diagnosed annually. Survival rates, though improving - vary worldwide. In countries with advanced care, the rate is 80 to 90 percent for those with a first-stage diagnosis
Korea's Government-Backed HOOXI Campaign Issues W Green Pay (WGP), First Blockchain Enabled Reward System for GHG Reduction by Individuals23.5.2018 16:00 | Tiedote
W Green Pay (WGP), the blockchain from HOOXI, Korea's government-backed Greenhouse Gas (GHG) reduction campaign, is taking a different tack at encouraging individuals to reduce GHG. While GHG reduction initiatives have been around, HOOXI is the first to directly reward individuals for reducing GHG. HOOXI introduces the first blockchain to help enable the reward system and facilitate the on-going reward distribution to individuals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523005643/en/ Youree Lee (third from left), CEO of W-Foundation, along with campaign ambassadors Korean idol group INFINITE members and Korean government officials, during the HOOXI Campaign Committee Inauguration Ceremony at The National Assembly of Republic of Korea on 26th April 2018. PHOTO: W-FOUNDATION W-Foundation, an international non-profit organization and a designated donation organization entitled by the Ministry of Strategy and Finance o
Nordson EFD Introduces New GV Series Gantry Fluid Dispensing Robot with Vision23.5.2018 15:04 | Tiedote
Nordson EFD, a Nordson company (NASDAQ: NDSN), the world’s leading precision fluid dispensing systems manufacturer, introduces the vision-guided GV Series automated fluid dispensing gantry robot. Specialized DispenseMotion™ software and an integrated CCD smart vision camera or simple pencil camera make the automated systems quick to set up and easy to program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523005033/en/ The new GV Series gantry robot from Nordson EFD is ideal for precision fluid dispensing onto substrates that require large working envelopes with market-leading deposit placement repeatability. (Photo: Business Wire) The CCD camera converts pixels into digital values to deliver precise, high-quality images. The proprietary dispensing software confirms workpiece presence and placement and automatically adjusts as in-process variations occur. “With working envelopes that range from 400 mm to 800 mm and unlim
NITI Aayog and ABB India Partner to Make India AI-Ready23.5.2018 13:30 | Tiedote
The National Institution for Transforming India (NITI Aayog), the think tank of the Indian government, and ABB India have signed a Statement of Intent (SoI) to support the Indian government to realize its ambitious vision of “Make in India” through advanced manufacturing technologies that incorporate the latest developments in robotics and artificial intelligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180523005618/en/ Anna Roy of NITI Aayog and Sanjeev Sharma, managing director of ABB India, sign a statement of partnership in advanced manufacturing technologies, including digital and AI, in New Delhi today. Looking on are Amitabh Kant, CEO of Niti Aayog, and Ulrich Spiesshofer, CEO of ABB (Photo: Business Wire) NITI Aayog will work with ABB to prepare key sectors of the economy, such as the power and water utilities sector, industries like food as well as the heavy industries sector; and the transport (rail and metr
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