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 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
Vertex Announces Long-Term Access Agreement in Sweden for Cystic Fibrosis Medicine ORKAMBI® (lumacaftor/ivacaftor)18.6.2018 14:00 | Tiedote
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that ORKAMBI® (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people with two copies of the F508del mutation, ages six and older, will be reimbursed in Sweden after concluding the three-party negotiations with TLV and the county councils. Reimbursement is effective from July 1. The innovative, long-term access agreement also provides a framework for the assessment and access of our future CF medicines. “We are delighted that people with CF in Sweden will join the thousands of others around the world who are already benefitting from our CF medicines,” said Simon Bedson, International General Manager at Vertex. “We commend the Swedish authorities for partnering with us on an innovative, long-term access agreement. In countries where Vertex remains actively involved in reimbursement discussions, we encourage these health authorities and governments to match the commitment
LG Chem Hosts Global Innovation Contest 2018 (GIC 2018)"Finding Innovations to Change the World"18.6.2018 14:00 | Tiedote
LG Chem (KRX: 051910) is exploring innovative technologies that will change the world. LG Chem announced that it would hold a Global Innovation Contest (GIC) for leading universities and research institutions around the world. This is the first time that a Korean chemical company is conducting technology contests for the entire world. From June 18th to September 30th, 2018, LG Chem will accept innovative technology ideas in five promising business areas: Energy, Environment, Functional materials, Bio technology and Platform technology. Global scholars and researchers who are interested in developing the next generation’s innovative technology and industry-academia collaboration research are welcomed to participate and submit the technical proposal through the official website (www.rnd.lgchem.com/global/gic). LG Chem will select internal experts and selection committees to evaluate the proposals considering technology innovation, marketability, and price competitiveness. Selected assign
Octapharma announces approval of new Nuwiq® product strengths in Europe, increasing dosing flexibility for patients with haemophilia A18.6.2018 10:06 | Tiedote
Octapharma announced today that the European Medicines Agency (EMA) has approved an extension of marketing authorisation for its human cell line-derived recombinant factor VIII (rFVIII) product, Nuwiq®. New single dose vial strengths of 2500, 3000 and 4000 International Units (IU) will be available in Europe, in addition to the current strengths of 250, 500, 1000 and 2000 IU. The new Nuwiq® vial strengths have been available in the US since September last year, following approval by the FDA. Nuwiq® is indicated in adults and children of all ages for on-demand treatment and prophylaxis, including during surgery, to prevent and control bleeding episodes in patients with haemophilia A. This expanded array of vial strengths has the potential to increase treatment options for patients with haemophilia A by improving dosing flexibility. Patients who previously required more than one vial per infusion may be able to reduce the number of vials needed. Nuwiq® is the only rFVIII available in an
STATS and SpokeHub Partner to Power Deeper, More Meaningful Conversations Around the 2018 FIFA World Cup18.6.2018 10:00 | Tiedote
Today, STATS, the worldwide leader in sports data and intelligence, and SpokeHub announced a new partnership to bring STATS Insights to SpokeHub’s social engagement platform, connecting worldwide World Cup football (soccer) fans with content that is more impactful. Download the app today to see the match scores, player insights, and engage with World Cup fans everywhere! STATS Insights leverages more than 37 years of research experience to deliver deep historical and comparative statistical insights, play-by-play descriptions and in-game trends based on events as they happen in the match. Before, during and after each match, SpokeHub will harness STATS Insights to amplify conversations among World Cup football communities. During the game, live Insights will deliver trends on players and teams based on in-game events, statistics and milestones. “No sporting event gets global attention like the World Cup, and every fan is looking for deeper analysis around their favorite teams and playe
Celltrion Completes Resubmission to FDA for Proposed Trastuzumab Biosimilar18.6.2018 05:53 | Tiedote
Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab). Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last year, respectively. However, it received CRLs (complete response letters) from the FDA related to the warning letter issued by the FDA in January 2018, related to the manufacturing facility in Incheon, South Korea. Celltrion had completed the resubmission for the approval of CT-P10, a proposed biosimilar to Rituxan® (rituximab) last month. In accordance with FDA regulations, the approval procedure will be usually finalized within six months from the resubmission, so Celltrion expects the approval for the U.S. market of the two proposed biosimilars within this calendar year. FDA has notified Celltrion of its re-inspection schedule regarding regular audit results, and
CES Asia: Innovation at the Speed of 5G15.6.2018 17:59 | Tiedote
CES Asia® 2018 wrapped today with the rapid pace of global innovation front and center over the show’s three day duration. The next stage of technology advancements were showcased across vehicle tech, robotics, artificial intelligence (AI), virtual and augmented reality, digital health and more. The event, 24 percent larger than last year in terms of footprint, cemented itself as the place to fully experience how the pace of technology is accelerating globally. CES Asia, the premier event for tech innovation in the Asian marketplace, will return to Shanghai, China, June 11-13, 2019. “5G and AI are igniting growth across the entire tech ecosystem changing the way we interact with technology and the world around us,” said Gary Shapiro, president and CEO, Consumer Technology Association (CTA)™. “It’s incredible to see technology refining and reinventing itself at such a fast pace. Just six months ago we were at CES with life-altering tech all around us. This week, I saw that technology re
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