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
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Brightree Acquires Mobile Delivery Provider Apacheta to Streamline HME Delivery17.12.2018 14:05 | Pressemelding
Brightree, a leading provider of cloud-based software helping out-of-hospital providers improve business performance and patient outcomes, today announced it has acquired privately held mobile delivery and cloud-based software-as-a-service (SaaS) provider Apacheta Corporation, further expanding the SaaS portfolio of Brightree’s owner, ResMed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181217005121/en/ The terms of the transaction were not disclosed. Apacheta offers mobile applications that empower companies to automate and streamline business processes in route sales, field marketing, pick-up and delivery, transportation and field services. Apacheta and its Media, PA-based employees will join Brightree, whose platform it has been integrated with since 2015. A secure mobile delivery module for ordering and tracking medical equipment was the number one feature request of HMEs in a recent customer satisfaction survey. Brigh
Transphorm’s High Voltage GaN FETs Amp Up Marotta Controls’ Military Grade High Frequency Power Supply17.12.2018 14:00 | Pressemelding
Transphorm Inc.—the leader in the design and manufacturing of the highest reliability and first JEDEC- and AEC-Q101 qualified gallium nitride (GaN) semiconductors—today announced with Marotta Controls that the Aerospace and Defense supplier’s upcoming power supply unit (PSU) replaces incumbent Silicon (Si) MOSFETs with high voltage GaN PQFN devices to offer advanced benefits. Marotta’s latest design operates at high frequency in a conduction-cooled mechanically constrained envelope. The supply’s topology features hard switching and an automatic transformer RESET capability where transistor voltage stresses are clamped to the input voltage. The GaN devices increase the PSU’s efficiency dramatically and alleviate a complex thermal design in the small form factor package. “The demand on our power supplies and expectation of performance is high,” explained Mike Scruggs, Principal Engineer, Marotta Controls. “This particular complex PSU needed to reliably convert and distribute power in a s
New Phase 3 data demonstrate superiority of TREMFYA®▼ (guselkumab) vs Cosentyx® (secukinumab) in delivering PASI 90 responses in the treatment of moderate to severe plaque psoriasis at week 4817.12.2018 12:56 | Pressemelding
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the ECLIPSE study demonstrating that TREMFYA® (guselkumab) was superior to Cosentyx® (secukinumab)* in treating adults with moderate to severe plaque psoriasis for the primary endpoint assessed at week 48. Data from the multicentre, randomised, double-blind head-to-head Phase 3 study demonstrated that 84.5 percent of patients treated with guselkumab achieved at least 90 percent improvement in their baseline Psoriasis Area Severity Index (PASI) score at week 48, compared with 70.0 percent of patients treated with secukinumab (p<0.001).1 These data, presented at the 3rd Inflammatory Skin Disease Summit (ISDS) in Vienna, 12–15 December, mark the first-ever results from a head-to-head study comparing an interleukin (IL)-23-targeted biologic therapy (guselkumab) with an IL-17 inhibitor (secukinumab). ECLIPSE is Janssen’s fourth Phase 3 study for guselkumab in plaque psoriasis2-4 and is part of a comprehen
Celgene Corporation Announces Celgene Cancer Care Links™ Program Grant Recipients17.12.2018 12:30 | Pressemelding
Celgene Corporation (NASDAQ:CELG) today announced ten programs selected for funding under its Celgene Cancer Care Links™ program, an initiative designed to support cancer healthcare capacity building in resource-constrained countries around the world. The programs selected are expected to support established institutions partnering with in-country medical centers that provide essential cancer care services including awareness and education, prevention, diagnosis and care. The Celgene Cancer Care Links program is an initiative of Celgene Global Health, which focuses on healthcare challenges facing patients in developing parts of the world. “Celgene Cancer Care Links is another program we have created to make a meaningful impact for patients and healthcare systems around the world,” said Mark J. Alles, Chairman and Chief Executive Officer of Celgene. “We are excited to announce the first round of grants through this initiative and wish these world-renowned organizations and institutions
Ras Al Khaimah Marks New Year’s Eve with Amazing Fireworks and New Guinness World Record Bid17.12.2018 11:14 | Pressemelding
This New Year’s Eve, Ras Al Khaimah is the place to be as the Emirate readies to host the most spectacular celebration with a 12-minute fireworks display - the bid for a new Guinness World Record display - and an array of family-oriented activities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181217005309/en/ Marjan, Ras Al Khaimah’s master-developer of freehold projects, will manage the show to mark 2019 with a glittering array of activities that will entertain all at its flagship development, Al Marjan Island. With three additional viewing areas around Al Marjan Island, New Year’s Eve in Ras Al Khaimah has fun and thrills in store for local and international visitors. Abdulla Al Abdouli, Managing Director & CEO of Marjan, said: “This year, we are offering exciting family activities that will delight all in the run-up to the amazing fireworks display that aims to set a new Guinness World Record. The event will position t
Mobidiag Announces Joint Venture with Autobio Diagnostics and €10m Equity Investment17.12.2018 09:52 | Pressemelding
Mobidiag Ltd., a commercial stage molecular diagnostics company addressing the spread of antimicrobial resistance, today announces that it has entered into a joint venture (‘JV’) agreement with Autobio Diagnostics (‘Autobio’), one of the leading clinical diagnostics companies in China, to commercialise the Novodiag® platform in China. In addition, Mobidiag announces that it has secured a separate €10m equity investment from Autobio. Lynx Financial (HK) Ltd, served as the exclusive financial advisor to Mobidiag in this transaction. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181217005272/en/ Mobidiag and Autobio will jointly invest €12.3m to establish a joint venture company in China. Autobio will invest €8m in cash to hold 65%, and Mobidiag will invest €4.3m to hold 35%. Mobidiag will grant to the JV an exclusive license for human infectious disease assays (except for sepsis) for China. Initial activities of the JV will i