MSD Animal Health Receives Positive Opinion from European Medicines Agency for BRAVECTO® Plus (fluralaner plus moxidectin) Spot-on Solution for Cats
MSD Animal Health (known as Merck Animal Health in the United States and Canada) today announced that the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for the veterinary medicinal product BRAVECTO® Plus (fluralaner plus moxidectin) spot-on solution for cats.
If granted marketing approval, BRAVECTO® Plus will be a sustained, broad-spectrum combination topical solution for cats with, or at risk from, both internal and external parasite infestations: ticks and fleas, heartworm, roundworm and hookworm. Detailed conditions of the product will be described in the summary of product characteristics (SPC), which will be published in the European public assessment report (EPAR) after marketing authorization has been granted by the European Commission.
BRAVECTO® Plus is designed for cats with, or at risk from, mixed parasitic infestations and is applied topically using the unique “Twist’n’Use”™ pipette design for ease of application.
Once applied, BRAVECTO® Plus provides immediate and persistent tick (Ixodes ricinus) and flea (Ctenocephalides felis) killing activity for 12 weeks, prevents heartworm disease caused by Dirofilaria immitis for 8 weeks, and also treats roundworm and hookworm.
Ticks and fleas must attach to the treated animal and commence feeding in order to be exposed to the active substance. BRAVECTO® Plus also can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
In 2014, BRAVECTO® was launched as a chewable tablet for dogs and, in 2016, BRAVECTO® spot-on was launched as a topical solution for dogs and cats. More than 60 million doses of BRAVECTO® have been distributed in 72 countries since its introduction.
About MSD Animal Health
For more than a century, MSD, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. MSD Animal Health, known as Merck Animal Health in the United States and Canada, is the global animal health business unit of MSD. Through its commitment to the Science of Healthier Animals™, MSD Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. MSD Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. MSD Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.msd-animal-health.com or connect with us on LinkedIn and Twitter.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2017 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Gail S. Thornton, + 1 973-937-5453
Marco Gassen, +49 89 456 14202
Pam Eisele, +1 267-305-3558
Michael DeCarbo, + 1 908-740-1807
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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Bridgestone Europe To Acquire TomTom Telematics For €910 Million Cash Consideration22.1.2019 09:58 | Tiedote
Bridgestone Europe NV/SA (“Bridgestone”), a subsidiary of Bridgestone Corporation in EMEA, has entered into an agreement with TomTom to acquire its telematics business, for a cash consideration of €910 million. The transaction will bring together the world’s largest tyre and rubber company with the number one provider of digital fleet solutions in Europe, creating a leading data platform for connected vehicles. TomTom Telematics will accelerate Bridgestone on its journey to becoming a mobility solutions leader in the region, and the combination of both companies’ offerings will allow Bridgestone to cross-sell tyres and solutions to a larger customer base. Furthermore, the data access will enhance Bridgestone’s virtual tyre development and testing as well as connected tyre innovation benefiting all customers including OEMs. New social, economic and technological megatrends are pushing the pace of change in the automotive industry and the future of vehicles is connected, autonomous, shar
GA Telesis Board Appoints Norman Liu as an Independent Director22.1.2019 09:00 | Tiedote
GA Telesis, LLC, a leading global commercial aviation integrated services provider, announces that its Board of Directors will appoint Norman C.T. Liu as an Independent Board Member effective February 1, 2019. Norm brings over 35 years of experience in aviation financing, infrastructure investing and investment banking. He is the former Chairman, President and CEO of GE Capital Aviation Services (“GECAS"), a world leader in commercial aircraft leasing and financing. He retired from GE at the end of 2016 after 30 years of service and is currently a senior advisor to various companies in the infrastructure and aviation sectors. He was an Advanced Leadership Fellow at Harvard in 2017 and also serves as an Adjunct Professor at University College Dublin in Ireland. He received his bachelor’s degree from Yale University and his MBA from Harvard Business School. “We are pleased that Norm will be joining our Board to participate in the explosive growth of our franchise,” said Abdol Moabery, Pr
Ferring, Rebiotix and Karolinska Institutet Extend Collaboration to Research Next Generation of Microbiome Treatments22.1.2019 09:00 | Tiedote
Ferring Pharmaceuticals and Karolinska Institutet announced today a five-year extension of their collaboration to explore the potential of the human microbiome in reproductive medicine and women’s health and gastroenterology. The collaboration brings together specialist expertise from Karolinska Institutet in early stage research, Rebiotix Inc. (acquired by Ferring in 2018), a late-stage clinical microbiome company, and Ferring’s therapeutic area and commercialisation capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190121005428/en/ The extension includes six reproductive health clinical studies of approximately 6,000 women and babies and four gastroenterology studies of approximately 3,000 adults and children, to further investigate the role of the microbiome in areas of high unmet need including recurrent pregnancy loss, preterm birth and inflammatory bowel disease. “The extension of this partnership presents a
Updated Analysis of Pivotal Study Reveals: Proactive, High Dosage of Venofer® Significantly Reduces Risk of Death or Major Cardiovascular Events in Haemodialysis Patients22.1.2019 09:00 | Tiedote
Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190121005426/en/ Further to the announcement on 29 October 2018, Vifor Pharma provides an update to the results of the Proactive IV irOn Therapy in haemodiALysis patients (PIVOTAL) trial. This update was necessitated by identification of a programming error in the original analysis by the investigators. The re-analysis of the data revealed a statistically significant improvement in the treatment effects of a higher dose of Venofer® (i.v. iron sucrose) compared with a lower dose. These results supersede those presented at the High-Impact Clinical Trial session at ASN Kidney Week 2018 and published on The New England Journal of Medicine website, NEJM.org, on 26 October 2018. The updated results can be viewed on: www.NEJM.org (DOI: 10.1056/NEJMoa1810742). In the updated results, the primary endpoint ‒ which was the composite of nonfatal myocardial infarction, nonfa
Logitech Delivers Record Q3 Sales, Raises Full-Year Profit Outlook22.1.2019 05:00 | Tiedote
Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the third quarter of Fiscal Year 2019. Q3 sales were $864 million, up 6 percent in US dollars and 8 percent in constant currency, compared to Q3 of the prior year. Q3 GAAP operating income reached $123 million, compared to $100 million in the same quarter a year ago. Q3 GAAP earnings per share (EPS) grew 40 percent to $0.67, compared to $0.48 in the same quarter a year ago. Q3 non-GAAP operating income grew 22 percent to $143 million, compared to $117 million in the same quarter a year ago. Q3 non-GAAP EPS grew 22 percent to $0.79, compared to $0.65 in the same quarter a year ago. Year-to-date cash flow from operations was $273 million, compared to $256 million in the same period a year ago. “We delivered record sales and profits in our biggest quarter of the year,” said Bracken Darrell, Logitech president and chief executive officer. “Our innovative, diverse portfolio drove double-digit growth acro
IFF Named to CDP’s A List for Climate Change and Water Security, Confirming Global Leadership for Sustainability22.1.2019 03:05 | Tiedote
Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), was recognized on CDP’s A List for Climate Change for the fourth consecutive year and received an “A” for Water Security for the first time, naming IFF a global leader in environmental responsibility. CDP, an international not-for-profit, assesses companies on the comprehensiveness of their disclosure, their awareness and management of environmental risks and their demonstration of best practices associated with environmental leadership, such as setting ambitious and meaningful targets. “We are delighted to be among an elite group of companies committed to environmental action,” said Andreas Fibig, IFF Chairman and CEO. “Inclusion in CDP’s A List for Water Security reflects the tremendous effort put into developing our next generation of environmental goals, EcoEffective+.” Mr. Fibig continued, “The recognition by CDP confirms that we are on the right path.” In 2018, the Company esta
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