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Owkin enters collaboration agreement with MSD to develop AI-powered diagnostics for cancer

  • Owkin to collaborate with MSD to develop and commercialize AI-powered digital pathology Microsatellite Instability High (MSI-H) diagnostics for four types of cancer.
  • The aim is to pre-screen patients for the MSI-H biomarker, which is found in a broad range of solid tumor types and is a strong predictor of PD1/PDL-1 inhibitor efficacy in cancer.

 

 

PARIS — (BUSINESS WIRE) — Owkin, a French-American biotechnology company that applies artificial intelligence (AI) to drug discovery, development, and diagnostics, on Monday announced that it has entered into a collaboration agreement with MSD, the trade name of Merck & Co Inc., Rahway N.J. U.S.A. to develop and commercialize AI-powered digital pathology diagnostics for the E.U. market.

 

Clinical trials have shown that the MSI-H tumor phenotype has potential prognostic and therapeutic importance, especially with the increased application of immune checkpoint inhibitor (ICI) therapies.1,2,3,4 As such, MSI-H has become an important genomic biomarker with applications across several types of cancer. As a result, testing for MSI-H is now recommended by consensus guidelines internationally.5,6,7,8

 

Meriem Sefta, Chief Diagnostics Officer, said, “This strategic alliance with MSD is focused on improving the way patients are diagnosed and receive treatment, advancing our shared mission of supporting healthcare providers in their adoption of innovative digital diagnostics. It is clear that there is a need for AI diagnostics that can both ease bottlenecks and resource pressures while also ramping up biomarker testing to match patients with optimal treatments.”

 

This collaboration seeks to develop a pre-screening procedure to improve testing rates for MSI-H in endometrial, gastric, small intestinal, and biliary cancers. In these cancer types, MSI-H prevalence is low and MSI-H screening is not routinely performed. The collaboration will initially be focused in the European Union.

 

“The application of AI technologies holds tremendous potential in the screening of patients and the diagnosis of disease,” said Scott K. Pruitt, associate vice president and head, Translational Oncology, MSD Research Laboratories. “We look forward to working with the Owkin team toward harnessing this opportunity to identify more patients with MSI-H cancers who may benefit from ICI therapy.”

 

Owkin, which currently has the only MSI digital pathology diagnostic CE-marked in colorectal cancer, will extend the development of its MSI-H AI diagnostics into four new cancer types, leveraging multimodal patient data from multiple academic centers and hospitals.

 

About Owkin

Owkin is a biotechnology company that combines the best of human and artificial intelligence to ensure every patient gets the right treatment. By understanding complex biology through AI, we identify new treatments, de-risk and accelerate clinical trials and develop AI diagnostics. Owkin uses privacy-enhancing federation to access up-to-date multimodal patient data that unlocks AI’s potential to power precision medicine.

 

Owkin is working to deliver AI diagnostics that integrate seamlessly into the digital pathology workflow to support accurate diagnosis at a fraction of the time and cost of existing tests. Our solutions help improve pathology workflows, pre-screen for biomarkers, and predict outcomes— giving healthcare providers a fuller picture of a patient’s disease. This means more patients can benefit from targeted therapies, making precision medicine more accessible to more patients at an earlier stage of their disease.

 

Owkin has raised over $300 million through investments from leading biopharma companies (Sanofi and BMS) and venture funds (Fidelity, GV and BPI, among others).

 

MSIntuit CRC

MSIntuit CRC is a CE-marked AI diagnostic that optimizes testing for microsatellite instability (MSI), a critical biomarker for CRC patients that represents a defect in a cell’s ability to correct mistakes that occur when DNA is replicated. Testing is now recommended by consensus guidelines, such as European Society for Medical Oncology (ESMO) in Europe and College of American Pathologists (CAP) in the US. MSI phenotyping is also essential to both the management of hereditary colorectal cancers and prognosis evaluation.

 

MSIntuit CRC is used for pre-screening and applies machine learning to digitized pathology slides to help pathologists and oncologists in their objective to facilitate better access to immunotherapy for all CRC patients.

 

MSIntuit CRC aims to have a significant impact on doctors and patients by decreasing workload and turnaround time, optimizing costs, and preserving tissue material and consumables. By using AI, this innovative tool may also support reproducibility through addressing inter-observer variability, with the end goal of optimizing quality and efficiency for critical tests.

 

1 KEYNOTE-177 (Pembrolizumab in Microsatellite-Instability–High Advanced Colorectal Cancer) https://www.nejm.org/doi/10.1056/NEJMoa2017699

2 CheckMate 142 (Nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Five-year follow-up from CheckMate 142) https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.3510

3 KEYNOTE-158 (Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study) https://pubmed.ncbi.nlm.nih.gov/35680043/

4 Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer https://pubmed.ncbi.nlm.nih.gov/36972026/

5 ESMO recommendation, Annals of Oncology 30: 1232–1243, 2019

6 NICE [Accessed June 2023]

7 Cancer Ind. Évaluation du statut MMR tumoral / synthèse. 2021; [Accessed June 2023]

8 National Comprehensive Cancer Network Genetic/Familial High-Risk Assessment: Colorectal (Version 1 2018).

Contacts

Stephanie Libous

Director of PR & Comms

stephanie.libous@owkin.com

Edward Farmer

PR Consultant

edward.farmer-ext@owkin.com

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Donor Network West, MTF Biologics and family of U.S. Marine and organ donor hero gather for rose dedication memorial ceremony

Special event unveiled a floragraph honoring 25-year-old Matthew Messina that will be featured in the 2024 Rose Parade®

 


EDISON, N.J. — (BUSINESS WIRE) — Donor Network West, an organization that saves and heals lives by facilitating organ and tissue recovery for transplantation and research, and MTF Biologics, a global non-profit organization that saves and heals lives by honoring donated gifts, hosted a memorial event honoring organ and tissue donor and U.S. Marine, Matthew Messina at MTF Biologics Tuesday, Dec. 12, 2023.

 

The event gathered the organ and tissue donation community and Messina’s family and featured a rose dedication to the family as well as the presentation of a floragraph featuring Messina that will travel across the country to be a part of the OneLegacy Donate Life Rose Parade® Float on Jan. 1, 2024.

 

“In a time when my family could see only darkness, the miracle of organ and tissue donation let us see that Matt’s life had done so much good for so many who needed help,” his mother Jan Messina explained. “It’s given us hope. And slowly but surely, we’re living our lives again.”

 

Messina dedicated his young life to service. As a U.S. Marine and big brother to two sisters, he is described as someone who put others before himself. His dreams of continuing to help others through work with young children was cut short when he was seriously injured when a drunk driver struck him in a hit-and-run crash in June 2023. Through organ and tissue donation, Messina was able to provide one last act of kindness in service to others. The donation of his kidneys, pancreas, and liver saved the lives of three others. As a tissue donor, he was able to help more than 100 people regain mobility and enjoy a better quality of life. In total, his organs and tissues helped people living in more than 25 states.

 

“Organ and tissue donor heroes like Matthew save lives and their legacies live on in recipients who have been given a second chance at life,” said Janice Whaley, President and CEO, Donor Network West. “It’s a privilege for Donor Network West to honor donors like Matthew and their families.”

 

Donor Network West and MTF Biologics are sponsors of the 2024 Donate Life Rose Parade® float, which will feature organ donors represented by floragraphs as well as individuals from across the U.S. who are transplant recipients and living donors. The 2024 Donate Life parade float, titled “Woven Together: The Dance of Life,” aims to inspire viewers to say yes to joining the registry as organ donors and to give hope to the 100,000 people who are on the national transplant wait list. The 2024 Donate Life float aims to repeat its success and recognition following the 2023 Donate Life float design which received the Tournament of Roses Sweepstakes Award, the highest Tournament of Roses honor.

 

“We remember donors like Matthew Messina as heroes. We’re grateful to be able to shine light on his life-saving gifts and honor him with a ‘floragraph’ as part of the OneLegacy Donate Life Rose Parade. Matthew’s story highlights the important work of MTF Biologics and Donor Network West, saving and healing lives,” said Joe Yaccarino, President, and CEO, MTF Biologics.

 

For more than 35 years, MTF Biologics has been processing tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. To date, MTF Biologics has recovered tissue from over 165,000 donors. Since its inception, they have provided over 10 million allografts to clinical partners.

 

About Donor Network West

Donor Network West saves and heals lives by facilitating organ and tissue recovery for transplantation and research. The organization was established in 1987 and is an official Donate Life organization accredited by the Association of Organ Procurement Organizations (AOPO) and the American Association of Tissue Banks (AATB). Federally designated to serve 45 counties in northern Nevada and northern California, Donor Network West has headquarters in northern Nevada and California and partners with the Department of Motor Vehicles and the state-authorized donor registries. For information, visit DonorNetworkWest.org and follow us on social media: @mydnwest.

 

About MTF Biologics:

MTF Biologics is a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients, and advancing science. They provide unmatched service, resources, and expertise to donors and their loved ones who give the gift of donation, people who depend on tissue and organ transplants, healthcare providers, and clinicians and scientists.

 

The International Institute for the Advancement of Medicine (IIAM), a Division of MTF Biologics, honors donors of non-transplantable organs by providing their gifts to the medical research community to combat and cure diseases. Statline, also a Division of MTF Biologics, provides specialized communications and technology expertise to organ, tissue, and eye procurement organizations, as well as the hospitals and patients that they serve. Its sister organization, Deutsches Institute for Zell-und Gewebeersatz – DIZG (The German Institute for Cell and Tissue Transplantation) expands its reach to patients across the globe. For more information, visit www.mtfbiologics.org.

Contacts

Nicole Smith

MTFBiologics@finnpartners.com

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DaleBoot partners with Aetrex to offer custom ski boots based on 3D foot scans

Partnership marks the first use of 3D foot scanning technology in custom ski gear

 

TEANECK, N.J. — (BUSINESS WIRE) — Aetrex, Inc., a global market leader in foot scanning technology and data-driven orthotics and comfort footwear, on Tuesday announced its partnership with custom ski boot manufacturer DaleBoot.

 

Leveraging Aetrex’s Albert 2 Pro foot scanning technology, DaleBoot will transition from manually measuring customer’s feet to using automated 3D foot scan data to design custom ski boots, improving fit accuracy and customer satisfaction and reducing refitting rates during a compact winter retail season.


After years of testing several foot scanning technologies, DaleBoot selected Aetrex technology for its accuracy and ease of use. Aetrex’s scanners use a pure computer vision model to create the most accurate 3D reconstruction of the foot available on the market. DaleBoot customers will complete a 20 second foot scan on the Albert 2 Pro and answer questions on ski experience, previous discomfort with ski boots and preferred snow conditions. DaleBoot will then use the 3D foot scan data and customer-reported information to develop a pair of custom ski boots with a personalized-fit shell, a fully custom liner and in-boot and on-ski stance balance and alignment, in under a week.

 

“Most skiiers consider wearing uncomfortable ski boots an unavoidable experience when hitting the slopes. But any footwear, including ski boots, designed to fit your feet should never be painful. Our partnership with DaleBoot aims to make that a reality by bringing detailed, accurate 3D measurements and data-driven insights to the ski boot development process,” said Larry Schwartz, CEO of Aetrex.

 

As of August 2023, Aetrex scanners are currently in use at 8 DaleBoot stores, including Salt Lake City, UT, and Kitzbuehel, Austria locations. The company plans to bring Aetrex foot scanners to all 60 points of distribution in ski shops around the world.

 

“Our commitment to continuous innovation has made DaleBoot the custom boot manufacturer of choice for the industry since 1969. Our customers know they can always count on us for the latest and greatest in ski boot technology,” said Rob Graham, CEO of DaleBoot. “Partnering with Aetrex during this next phase of our evolution makes our boots more personalized and data-driven than ever before.”

 

To learn more, visit www.aetrex.com/technology or contact Aetrex National Accounts Manager Justin Dyszelski at jdyszelski@aetrex.com to discuss leveraging Aetrex technology for developing snow sports gear.

 

About Aetrex

Aetrex, Inc. is widely recognized as a global leader in foot scanning technology and data-driven orthotics and comfort footwear. Aetrex has developed state-of-the-art foot scanning devices, including Albert, Albert 2 Pro and Albert 3DFit (2022 and 2023 CES Innovation Award Honorees), Albert Pressure and iStep, designed to accurately measure feet and determine foot type and pressure points. Since 2002, Aetrex has placed over 12,000 scanners worldwide that have performed more than 50 million unique customer foot scans, currently averaging more than 2.5 million scans a year.

 

The company is renowned for its over-the-counter orthotics – the worlds #1 premium foot orthotic. With fashion, function and quality at the forefront, Aetrex also designs and manufactures stylish, performance footwear. Based in New Jersey, Aetrex is consistently named one of New Jersey’s Top 100 Privately Held Companies and was also included in NJBIZ’s Top 30 Manufacturing Companies. It has remained privately owned by the Schwartz family for three generations. For additional information, visit www.aetrex.com.

 

About DaleBoot

Since its inception in 1969, DaleBoot has been highly focused on designing and manufacturing fully custom, high performance ski boots. With its factory and North American Headquarters based in Salt Lake City, and their European HQ located in the heart of the Alps in Kitzbuehel, Austria, DaleBoot provides worldwide coverage through its exclusive retail partner network. With 14 patents issued in its name, the company has chartered a course to address real customer issues, facing 85% of the skiing population, who experience problems, from large to small, with their ski boots. The DaleBoot process includes a complete athletic and bio-mechanic assessment, a series of 3D measurements, shell and liner customization, in-boot stance balance and alignment, and true on-ski cant correction. The result is a high performance ski boot that fits comfortably and is exciting to ski.

 

Founded by Mel Dalebout, an alternate for the 1952 U.S. Olympic Ski Team, and Intermountain Ski Hall of Fame inductee, the company was purchased by Rob Graham, a former U.S. freestyler, in 2007. Graham’s passion for the sport and deep business and orthopaedic acumen has propelled the company forward in terms of ski boot design and development, while establishing a new line of business dedicated to the design and manufacturing of devices used for orthopaedic surgeries. The company remains independently owned and operated. For more information on DaleBoot, please visit www.daleboot.com.

Contacts

Simone Migliori

Matter Communications

aetrex@matternow.com

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Best’s Review looks ahead to 2024 key issues

OLDWICK, N.J. — (BUSINESS WIRE) — In a new article, Best’s Review speaks to experts about what they see as the insurance industry’s top issues in the coming year.

 

Hot topics include natural catastrophes and climate risk, generative artificial intelligence, cyber risk, litigation and nuclear verdicts, as well as the U.S. presidential election.

 

The insurance workforce is also in the spotlight as layoff announcements have accelerated. Read the full story in “Insurers Look Ahead to 2024 and Key Issues: Catastrophes, Inflation, Layoffs, AI and More.”

 

Best’s Review is AM Best’s monthly insurance magazine, covering emerging issues and trends and evaluating their impact on the marketplace. The complete content of Best’s Review is available here.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Patricia Vowinkel
Executive Editor, Best’s Review®
+1 908 882 1771
patricia.vowinkel@ambest.com

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MATTER opens applications for accelerator focused on reducing maternal mortality in the US

Health Care Service Corporation, Laerdal Million Lives Fund, BayCare, Parkview Health, University of Chicago Medicine, Organon and Stryker to support cohort of women’s health startups; including $125,000 of investment for each selected company

CHICAGO — (BUSINESS WIRE) — MATTER, the premier healthcare incubator and innovation hub, has opened applications for the second 51 Labs, an accelerator focused on women’s health.

 

This year’s program focuses on preventing maternal mortality in the U.S. before, during and after birth and receives support from Health Care Service Corporation, Laerdal Million Lives Fund, BayCare, Parkview Health, University of Chicago Medicine, Organon and Stryker.

 

Earlier this year, the Centers for Disease Control and Prevention published a report showing that the maternal mortality rate in the U.S. worsened by 40 percent from 2020 to 2021.1 The maternal mortality rate is now the highest in the U.S. since 1965 and is far worse than other industrialized nations.

 

While all ages and races saw an increase in maternal mortality in 2021, many inequities still exist due to a variety of factors, including but not limited to access to quality care, socioeconomic status, race and education level. For example, Black women are three times as likely to die from pregnancy or pregnancy-related causes as white women in the U.S.2

 

“51 Labs is designed to address gaps in investment and innovation in women’s health,” said Steven Collens, CEO of MATTER. “We are pleased to partner with seven key industry stakeholders to help a cohort of startups advance solutions to help address the maternal mortality crisis in the U.S.”

 

The Laerdal Million Lives Fund, a global venture capital fund dedicated to transformative technologies that can help save lives, will serve as a capital partner for this cohort of 51 Labs companies. “Many maternal deaths are preventable. By investing in enabling technologies and digital solutions that can drive early interventions with high life saving potential and quality improvement initiatives, we can help scale companies working in this critical area,” said Becca Shmukler, principal of Laerdal Million Lives Fund.

 

The second cohort of the 51 Labs accelerator will address the question:

 

How can we prevent maternal mortality in the U.S. before, during and after birth?

The program will have three tracks: 1) supporting access to regular prenatal care to identify and mitigate potential risk factors earlier; 2) lowering the incidence of maternal health complications; and 3) supporting mothers during the 12 months after giving birth.

 

“It’s critically important to support innovative solutions to help moms and babies thrive,” said Dr. Monica Berner, chief clinical officer for Health Care Service Corporation. “Earlier this year, HCSC launched an expanded maternal and infant health initiative to improve health outcomes by increasing access to care, reducing care gaps, and educating and engaging residents on a community level. This 51 Labs program is another way we can help support other innovators who are seeking to tackle this critical issue.”

 

Applications for the 12-week accelerator are now open. Participating startups will benefit from one-on-one mentoring with industry experts, workshops, interactive roundtable discussions, forums and more. Additionally, each of the selected companies will receive an investment of $125,000, including $100,000 cash from the Laerdal Million Lives Fund and $25,000 of services from MATTER.

 

The program will culminate with a final showcase in May 2024.

 

For more information, email 51labs@matter.health.

 

About MATTER

At MATTER, we believe collaboration is the best way to improve healthcare. The MATTER collaborative includes more than 800 current and alumni startups from around the world, working together with dozens of hospitals and health systems, universities and industry-leading companies to build the future of healthcare. Together we are accelerating innovation, advancing care and improving lives. For more information, visit matter.health and follow @MATTERhealth.

 

About HCSC

Health Care Service Corporation is the country’s largest customer-owned health insurer, serving more than 18.6 million members in its health plans in Illinois, Montana, New Mexico, Oklahoma and Texas. A Mutual Legal Reserve Company, HCSC is an independent licensee of the Blue Cross and Blue Shield Association.

 

About Laerdal Million Lives Fund

The Million Lives Fund invests in entrepreneurs who are developing and deploying new, emerging technologies capable of saving lives and enhancing healthcare quality and outcomes regardless of demographics or geography. The $100 million fund targets digital health and technology companies whose solutions can improve mortality rates and help reach its goal of helping to save 1 million lives annually by 2030. Investments span across medical education innovations to early interventions, therapeutics and tech-enabled care models. For more information, visit www.laerdalmillionlives.com.

 

About BayCare

BayCare is a leading not-for-profit healthcare system that connects individuals and families to a wide range of services at 16 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. The system is West Central Florida’s largest provider of behavioral health and pediatric services and its provider group, BayCare Medical Group, is one of the largest in the region. BayCare’s diverse network of ambulatory services includes laboratories, imaging, surgical centers, BayCare Urgent Care locations, wellness centers and one of Florida’s largest home care agencies, BayCare HomeCare. Its Medicare Advantage insurance, BayCarePlus, is among the region’s few 5-star-rated plans and the system is ranked in the top 20 percent of large health systems in the country by FORUTNE/Merative™. BayCare’s mission is to improve the health of all it serves through community-owned, health care services that set the standard for high-quality, compassionate care.

 

About Parkview Health

Parkview Health is a not-for-profit, community-based health system serving a northeast Indiana and northwest Ohio population of more than 1.3 million. Parkview Health’s mission is to improve health and inspire well-being in the communities it serves. With more than 16,000 co-workers, it is the region’s largest employer. Parkview Health includes 13 hospitals and an extensive network of primary care and specialty care physicians. The flagship Parkview Regional Medical Center campus includes services such as the Parkview Packnett Family Cancer Institute, Parkview Heart Institute, Samaritan flight and ground transport program, Parkview Ortho Hospital, a certified stroke center, verified adult and pediatric trauma centers, Women’s & Children’s Hospital and an outpatient services center. Parkview has been named one of America’s Best-In-State Employers by Forbes and made Newsweek’s list of Top 100 Most Loved Workplaces.

 

About University of Chicago Medicine

The University of Chicago Medicine, with a history dating back to 1927, is one of the nation’s leading academic medical institutions. UChicago Medicine comprises the University of Chicago Medical Center, which offers a full range of primary and specialty care for adults and children through more than 40 institutes and centers; Ingalls Memorial, a community-based hospital and outpatient facility; a micro-hospital in northwest Indiana, a network of outpatient clinics and physician practices throughout Chicagoland and Northwest Indiana; the Pritzker School of Medicine, one of the top medical schools in the nation; and the University of Chicago Biological Sciences Division, with an affiliated 12 Nobel Prize winners in physiology or medicine.

 

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

 

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

 

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, Twitter and Facebook.

 

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.

_____________

1 “Maternal Mortality Rates in the United States, 2021,” Centers for Disease Control and Prevention, 2023.

2 “U.S. Maternal Mortality Hits Highest Level Since 1965,” The Wall Street Journal, 2023.

Contacts

Julia Cremin

jcremin@pcipr.com
331-333-2928

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Business Culture Economics Healthcare International & World Lifestyle News Now! Science

Merck Animal Health receives positive CVMP opinion for an injectable formulation of BRAVECTO® (Fluralaner) for use in dogs

RAHWAY, N.J. — (BUSINESS WIRE) — Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) issued a positive opinion for BRAVECTO® (fluralaner) 150 mg/ml powder and solvent for suspension for injection for dogs.

 

The CVMP recommends the product for approval for the treatment and persistent killing of fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, Ixodes hexagonus, and Dermacentor reticulatus) for 12 months. If the European Commission (EC) adopts the recommendation, this injectable formulation of BRAVECTO can be used by or under the supervision of a veterinarian and for administration to dogs and puppies six months of age and older.

 

“Since our initial launch of BRAVECTO nearly a decade ago, Merck Animal Health has been committed to bringing innovations to our customers that protect pets longer from flea and tick infestations and the associated health risks,” said Rick DeLuca, executive vice president and president, Merck Animal Health. “With today’s positive opinion of this injectable formulation of BRAVECTO, the first and only once-yearly injectable flea and tick medication, pet owners are one step closer to a new, convenient option to help ensure year-round comprehensive protection from fleas and ticks without the need for administering multiple doses of medication.”

 

Certain ticks can transmit serious infections in dogs. Many ticks can live in both warm and cold temperatures and are known to feed on dogs,1 making continuous year-round protection of utmost importance for pets and people.

 

“Though people often think of flea and tick season during the summer months, studies have shown that while fleas and ticks are most active from early spring through the fall, they can be a threat year-round,” said Holger Lehmann, vice president, Pharmaceutical Research & Development, Merck Animal Health. “If approved, a once-yearly dosing of BRAVECTO injectable can provide a long duration of protection, simplifying care for both pet owners and veterinarians. This promotes compliance and helps ensure continuous protection.”

 

Based on the CVMP’s recommendation, the EC is expected to issue a decision for marketing authorization in the European Union (EU) during the first quarter of 2024.

 

About BRAVECTO® (fluralaner)

Since its introduction in 2014, BRAVECTO has provided longer-lasting flea and tick protection, with more than 300 million doses distributed in more than 100 countries. BRAVECTO is available in a variety of formulations, including products for both dogs and cats.

 

The flea and tick life cycles can also last for months and missed doses of monthly treatments may leave gaps in protection.

 

Providing pets with continuous flea and tick protection is essential – whether the pet goes outside or not. Contrary to popular belief among pet parents, fleas and ticks are not only active in the spring and summer months, but they are a year-round risk.

 

Fleas and ticks can easily infest dogs and cats. They also can bite and pose health risks to human family members whether at home or outdoors. Ticks can spread serious diseases including rickettsiosis, anaplasmosis and borreliosis (Lyme disease), while fleas are the most common external parasite found on pets and can transmit bartonellosis (Cat Scratch disease) and tapeworms.

 

About Merck Animal Health

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of Merck. Through its commitment to The Science of Healthier Animals®, Merck Animal Health offers veterinarians, farmers, producers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn, Facebook, X (Formerly Twitter) and Instagram.

 

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, 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 candidates that the candidates 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 the global outbreak of novel coronavirus disease (COVID-19); 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 Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

References

[1] Probst J, Springer A, Topp AK, Bröker M, Williams H, Dautel H, Kahl O, Strube C. Winter activity of questing ticks (Ixodes ricinus and Dermacentor reticulatus) in Germany− Evidence from quasi-natural tick plots, field studies and a tick submission study. Ticks and Tick-borne Diseases. 2023 Nov 1;14(6):102225.

Contacts

Media:

Kim Gorode

(973) 255-8904

Kim.Gorode@merck.com

Investor:

Peter Dannenbaum

(732) 594-1579

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Non-GMO now considered higher priority for tea consumers than Fair Trade by industry professionals

Firsd Tea’s new report suggests industry experts view Non-GMO certification as more important to consumers than Fair Trade.

 

“Importantly, Organic certification is still the predominant priority standard for consumers in the eyes of industry professionals.”

— Jason Walker, Marketing Director, Firsd Tea

SECAUCUS, N.J. — According to a new report from Firsd Tea, the largest importer of Chinese tea in the U.S., most professionals in tea and related industries say Non-GMO certification is now more important than Fair Trade for their consumers—a trend change from last year’s findings.

 

Specifically, most respondents in 2023 viewed Non-GMO certification (81%) as the second-most important standard and Fair Trade (68%) as the third-most important standard to consumers—a reversal from 2022’s survey findings.

 

“Though it’s unsurprising that Non-GMO certification has grown in perceived importance for consumers with our survey-takers, it was interesting to see it leap past Fair Trade certification this year,” Firsd Tea marketing director, Jason Walker, explains. He adds, “Importantly, Organic certification is still the predominant priority standard for consumers in the eyes of industry professionals.”

 

Along with revealing the Non-GMO certification’s increasing importance, the study also found:

  • Most survey-takers remain worried about the effects of climate change on their business operations (80% in 2022 vs. 75% in 2023).

 

  • Tea is still considered the most sensitive industry to the effects of climate change by most professionals in tea and related industries (93% in 2022 vs. 95% in 2023).

 

  • Most respondents in tea and related industries still agree Organic Certification is the most important standard to consumers (84% in 2022 vs. 88% in 2023).

 

  • Compared with Firsd Tea’s 2022 study, Vietnam (+37%), Kenya (+33%), China (+26%), and Sri Lanka (+26%) saw outstanding perceived sustainability improvements in 2023.

 

  • Most respondents in tea and related industries report improved outlooks on progress made in sustainability from 10 years ago, the current state of sustainability in tea, and the trajectory for the next 10 years.

 

“We look forward to this critical study providing important information to stakeholders across tea and related industries, hopefully helping their decision-making and giving them a more accurate pulse on their industry peers,” explains Firsd Tea executive director, Shengyuan Chen.

 

Firsd Tea Sustainability Perspectives 2023 is the second annual survey that continues a first-of-its-kind global 2022 study to gauge opinions of tea sustainability among associated experts.

 

“In this post-pandemic era, consumers remain focused on healthy lifestyles and recognize the importance of protecting the environment. The significance of organic certification with growing numbers of tea consumers echoes the mindset of many coffee consumers as well, specifically, that organic certification hits two touch points: it is good for the body and it is good for the planet,” says Vanessa L. Facenda, editor, Tea & Coffee Trade Journal.

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Kirby McInerney LLP announces the filing of a securities class action on behalf of Outlook Therapeutics, Inc. (OTLK) investors

NEW YORK — (BUSINESS WIRE) — $OTLK #classactionlawsuit — The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of those who acquired Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) securities during the period from Dec. 29, 2022 through Aug. 29, 2023, inclusive (the “Class Period”). Investors have until Jan. 2, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

 

Outlook is a late clinical-stage biopharmaceutical company that focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications. The Company’s lead product candidate is ONS-5010, an ophthalmic formulation of the antibody bevacizumab for the treatment of wet age-related macular degeneration (“wet AMD”) and other retina diseases.

 

In August 2021, Outlook announced the topline readout of data from its pivotal Phase 3 NORSE TWO trial of ONS-5010 for the treatment of wet AMD. According to the Company, this data, among other things, “demonstrated clinically relevant and highly statistically significant results” that supported the submission of a biologics license application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for ONS-5010 for the treatment of wet AMD, which the Company planned to submit to the FDA in the first quarter of 2022. In March 2022, Outlook announced that it had submitted the ONS-5010 BLA to the FDA.

 

In May 2022, the Company voluntarily withdrew the ONS-5010 BLA to provide additional information requested by the FDA. Following receipt of further correspondence from the FDA, the Company purportedly confirmed the additional information necessary to re-submit the BLA for ONS-5010 and resubmitted the BLA in August 2022.

 

On August 30, 2023, Outlook announced that the FDA had issued a complete response letter to the ONS-5010 BLA. The Company advised that the FDA could not approve the BLA during this review cycle due to several issues. On this news, the price of Outlook shares declined by $1.141 per share, or approximately 80.92%, from $1.41 per share to close at $0.269 on August 30, 2023.

 

The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose that: (i) there was a lack of substantial evidence supporting ONS-5010 as a treatment for wet AMD; (ii) Outlook and/or its manufacturing partner had deficient chemistry manufacturing and controls and other manufacturing issues for ONS-5010, which remained unresolved at the time the ONS-5010 BLA was re-submitted to the FDA; (iii) as a result of all the foregoing, the FDA was unlikely to approve the ONS-5010 BLA in its present form; and (iv) accordingly, ONS-5010’s regulatory and commercial prospects were overstated.

 

If you purchased or otherwise acquired Outlook securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.

 

Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website: https://www.kmllp.com.

 

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Contacts

Kirby McInerney LLP

Thomas W. Elrod, Esq.

212-699-1180

https://www.kmllp.com
investigations@kmllp.com

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Area Park Naturalist explains: Tap, tap, tap! Woodpeckers at work

Many of us recognize that tapping sound as belonging to a woodpecker. But do you know why they are tapping? One reason may be that they are looking for their next meal.

A woodpecker’s diet consists of a variety of wood-boring insects, such as larvae, carpenter ants, termites, and carpenter bees. These insects are readily found in dead or diseased trees and the tapping means the woodpeckers are drilling a hole to get to the insects.

However, the Yellow-bellied Sapsucker, a migratory woodpecker, will tap holes into trees to lick up some tasty sap along with the insects that are also attracted to the sap.

A second reason you may hear tapping is when woodpeckers are creating cavities to nest in. They will choose dying trees, as those are easier to dig out a cavity.

You may see wood shavings at the bottom of the tree, or if you witness them excavating, you may notice wood shavings getting tossed out and floating down to the ground. Each species will create a cavity that is deep enough for their eggs and a bird to sit in.  Our smallest woodpecker, the Downy, creates an entrance hole that is only 1 ½ inches in diameter, while the largest woodpecker, the Pileated, creates an oblong cavity that is 3 ½ inches wide and 4 ¾ inches tall and takes almost 6 weeks to build.

Woodpeckers also use drumming on trees to communicate to other woodpeckers. They are alerting others that this is their territory, and also trying to attract a mate. But what does it mean when a woodpecker drums on your metal chimney? Well, this drumming sound is much louder than on a tree, like using cymbals in an orchestra, and therefore sends across a much stronger louder message.

Unfortunately, if you hear a woodpecker drumming on your siding, or see evidence of holes, it’s time to call an exterminator, because this probably means that your siding has some of those yummy insects’ woodpeckers enjoy.

Next time you go out into a forested area, listen for a tap, tap, tap, and then look carefully for woodpeckers pecking into decaying trees. Better yet, join us for a Woodpecker Walk on Friday, February 23 where we will be looking for evidence of woodpeckers and the seven different species found in Mercer County parks. Use this link to register.

— Alexandria Kosowski, Park Naturalist

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Business Culture Lifestyle Science

Rotunda Capital Partners invests in Door Pro America

Partnership supports growth of market leader in the direct-to-consumer residential install, repair and replacement garage door services industry.

 

BETHESDA, Md. & EVANSTON, Ill. — (BUSINESS WIRE) — Rotunda Capital Partners “(Rotunda)” has invested in Door Pro America “(Door Pro” or the “Company),” a leading direct-to-consumer installer and service provider of residential garage doors with eight strategic locations throughout the United States.

 

Headquartered in Gainesville, Virginia, Door Pro has expanded rapidly through organic growth since its founding in 1998.

 

Currently, Door Pro is one of the largest and most reputable residential garage door service providers in the country, serving customers throughout the U.S. with facilities in Virginia, Maryland, Illinois, Washington, Oregon, New York, New Jersey, and Colorado. Fueled by their market leading reputation, Door Pro is a leading installer of Amarr Garage Doors & Commercial Doors and LiftMaster garage doors and openers and is quickly becoming a premier provider of 24/7 maintenance services, serving the residential repair, replacement and new installation markets.

 

The Company will continue to be led by Co-Presidents Larry Notto and Chris Traxler, who will also maintain an ownership stake alongside Rotunda Capital Partners Fund III. As part of the transaction, the Company has partnered with Jeff Mick, the former President of Amarr Garage Doors & Commercial Doors. Mr. Mick serves as a strategic advisor and member of the Board of Directors.

 

Dan Lipson, a Rotunda Managing Partner, said, “Door Pro is one of the premier national platforms in the residential garage door services industry. The Company has grown rapidly by adding new branch locations throughout the country, all the while maintaining their leading reputation of excellent customer service. We are excited to partner with Larry, Chris and the team to continue to build on the Company’s track record of growth and success.”

 

“Leveraging our significant experience in the residential services space, including our investments in Storm Smart, Canter Power Systems and U.S. Waterproofing, we quickly recognized Door Pro’s growth potential and position as the acquiror of choice for residential garage door service providers looking for growth investments,” added John Fruehwirth, a Managing Partner at Rotunda.

 

Mr. Notto commented, “From my first meeting with the Rotunda team, I knew they would be the best partner to help us take Door Pro to the next level. Their expertise and track record in residential services is extremely impressive, and their expertise in growing founder-owned businesses, especially in the residential services arena, is well recognized. Both Chris and I look forward to partnering with Rotunda and leveraging their experience and resources to grow our company faster than we could have on our own.”

 

Ryan Aprill, Rotunda Principal, added, “Door Pro is another successful example of Rotunda’s differentiated and thematic sourcing approach to partnering with family and founder-owned companies. We have been working with Jeff for some time to identify the right platform in the residential garage door service industry and we believe we have found it in Door Pro. Rotunda is excited to continue scaling the business, both organically and through acquisitions.”

 

The Door Pro investment represents the third platform in Rotunda’s latest fund, Rotunda Capital Partners Fund III, L.P. The Rotunda team included Dan Lipson, John Fruehwirth, Ryan Aprill, Cara Hauan and Karthik Munugala. Benesch Friedlander Coplan & Aronoff LLP served as legal counsel to Rotunda.

 

About Door Pro America

Door Pro America is a leading provider of residential install, repair and replacement garage door services across the U.S. Founded in 1998, Door Pro America has established a reputation for providing the highest quality customer service available in its eight markets, including Virgnia, Maryland, Illinois, Washington, Oregon, New York, New Jersey and Colorado. Door Pro America holds Double Diamond and Premier dealer status with Amarr Garage Doors & Commercial Doors and LiftMaster. More information about Door Pro can be found at www.doorproamerica.com.

 

About Rotunda Capital Partners

Rotunda Capital Partners is an operationally oriented private equity firm focused on transforming family-founder owned companies into dynamic, data-driven platforms able to achieve and manage significant growth. Since its founding in 2009, Rotunda has partnered with management teams to build great businesses within three primary sectors: value-added distribution, asset-light logistics and industrial, business, and residential services. Rotunda strives to achieve replicable results by implementing its Rotunda Performance System to create strategic alignment, develop lean processes and create robust, data-driven infrastructures. For more information, visit www.rotundacapital.com.

Contacts

Margaux Valle

Head of Business Development

Rotunda Capital Partners

(240) 2962-1707

PR@rotundacapital.com