How to correct opioid misinformation? Spend $285M on counter-marketing, expert says in J&J trial

fiercepharma | June 11, 2019

How to correct opioid misinformation? Spend $285M on counter-marketing, expert says in J&J trial
Countless lawsuits have sought to estimate the costs of fixing the U.S. opioid and addiction epidemic. Now, thanks to an expert in Oklahoma's ongoing trial against Johnson & Johnson, we have one dollar figure. Oklahoma would have to spend nearly $285 million to mount a counter-marketing campaign that would offset pharma’s influence over pain prescribing, Saxum Strategic Communications chairman and CEO Renzi Stone testified during the state’s trial against Johnson & Johnson on Monday. And that's just the cost of a campaign to spread awareness about the harms of opioids, Stone pointed out in testimony reported by the Oklahoman. It doesn't include the other costs of fixing the state's opioid crisis.

Spotlight

Katherine Bakshian Chiappinelli, Ph.D., joined the GW Department of Microbiology, Immunology and Tropical Medicine University in 2017 as an Assistant Professor.Dr. Chiappinelli graduated with a B.S. in Biology and Music from Haverford College in 2007 and received her Ph.D. in Developmental, Regenerative, and Stem Cell Biology from Washington University in St. Louis under the supervision of Dr. Paul Goodfellow in 2012. Dr. Chiappinelli pursued postdoctoral studies at Johns Hopkins University with Dr. Stephen Baylin investigating the epigenetic control of immune signaling in cancer cells. Her research focuses on how epigenetic therapies can be used against cancers, specifically in the context of arming the host immune system to fight cancer cells.


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PHARMACY MARKET

Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System

Envista Holdings Corporation | December 28, 2021

Envista Holdings Corporation announced that the U.S. Food and Drug Administration has cleared the Nobel Biocare N1™ implant system. Boasting a biologically driven design of components and forward-thinking treatment protocols, the N1™ implant system represents a significant step forward in patient-centric implant solutions. More than an implant, N1 is a comprehensive system of dedicated instruments, prosthetic components, and surgical protocols. New features of the system include an implant designed for immediate placement and predictable insertion torques, a trioval conical connection for the abutment to slide into place, and an emergence profile designed for soft tissue maintenance. Innovative site preparation for greater patient comfort The Nobel Biocare N1™ system includes the novel feature of the OsseoShaper™, an instrument that redefines site preparation and is set to reshape implantology with optimized workflows, greater patient comfort and faster treatment times. By gently 'shaping' the osteotomy at low speed and without irrigation, the OsseoShaper™ reduces noise and vibration compared to conventional drilling protocols. This leads to improved patient comfort and has been shown in pre-clinical studies to preserve vital bone. Embracing surface chemistry and digital workflows Fully embracing the new Mucointegration™ concept, the Nobel Biocare N1™ features the Xeal™ and TiUltra™ surface treatments. With their specially tailored surface chemistry and topography, TiUltra implants and Xeal abutments can benefit from this design to optimize tissue integration at every level. Nobel Biocare N1™ will be further integrated into the digital workflow with the DTX Studio™ suite, giving dental professionals more opportunities to provide patients with shorter time to teeth. "For over 50 years, Nobel Biocare has been a pioneering force behind implantology. The demand for high quality patient-centric solutions is higher than ever, and the Nobel Biocare N1™ system enables clinicians to set a new standard in personalizing, digitizing, and democratizing the implant treatment experience they can offer patients." Amir Aghdaei, Chief Executive Officer, Envista Patrik Eriksson, President Nobel Biocare, explained, "Drilling protocols have hardly changed over the past 50 years. However, the OsseoShaper™ provides a completely new approach designed for patient comfort, streamlined workflow, and improved predictability; while at the same time, respects biology to achieve fast osseointegration. We are excited to partner with clinicians to bring the N1 system to US-based patients." About Nobel Biocare Nobel Biocare is a world leader in the field of innovative implant-based dental restorations. The company's portfolio offers solutions from single tooth to fully edentulous indications with dental implant systems (including key brands NobelActive® and NobelParallel™ and ceramic implant NobelPearl™*) a comprehensive range of high-precision individualized prosthetics and CAD/CAM systems (NobelProcera®), digital solutions for treatment planning and guided surgery (NobelClinician® and DTX Studio™ suite) as well as biomaterials. Nobel Biocare supports its customers through all phases of professional development, offering world-class training and education along with practice support and patient information materials. The company is headquartered in Zurich, Switzerland. Production takes place at five sites located in the United States, Sweden, and Germany. Products and services are available in over 80 countries through subsidiaries and distributors. *Distributed by Nobel Biocare. Manufactured by Dentalpoint AG About Envista Envista is a global family of more than 30 trusted dental brands, including KaVo, Kerr, Nobel Biocare, and Ormco, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. With a foundation comprised of the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, Envista is well equipped to meet the end-to-end needs of dental professionals worldwide. Envista is one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry.

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BUSINESS INSIGHTS

Dermaliq Therapeutics Signs USD 15 Million Series A Round to Advance Three Transformative Drug Therapies into Clinical Trials

Dermaliq Therapeutics | January 18, 2022

Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd. today announced the establishment of Dermaliq Therapeutics, Inc (Dermaliq), a newly formed Delaware-based pharmaceutical development company, and the signing of a USD 15 million Series A financing round. 3E Bioventures Capital, a leading international life science investor, led the round and was joined by Beijing Whale Technology Corporation Ltd. Dermaliq's existing shareholder Novaliq has transferred, and licensed Intellectual Property (IP) related to the field of dermatology to Dermaliq. Skin diseases are the fourth leading cause of non-fatal disease burden worldwide, underscoring the role of dermatology in the growing field of global health. Skin conditions have significant impact on patients' well-being, mental health, and social participation. Although topical and local delivery of active ingredients to diseased skin is the preferred treatment route for the majority of patients, current therapies often lack satisfactory skin penetration and patient compliance. Dermaliq is developing the next generation of skin care therapies to enhance targeted penetration into skin tissues and to reduce unwanted side effects for millions of patients. The unique and proprietary technology now owned by Dermaliq, called hyliQ™, is designed to allow cutaneous drug delivery with unmatched bioavailability. The technology enables the development of superior, highly effective liquid drug products with exceptional cosmetic properties. The proceeds will be used to conduct three Phase 1/2a clinical dermatology programs with the goal to demonstrate safety and efficacy and to advance this novel skin care drug category to market to improve the lives of millions of patients: DLQ01 is a liquid drug candidate for the topical treatment of female and male androgenetic alopecia, targeting the prostamide E2 (PGE2) receptor in hair bulbs through specific follicular drug delivery. DLQ02 is a novel and liquid topical calcineurin inhibitor drug therapy for plaque psoriasis, particularly in difficult to treat areas. DLQ03 is a broad-spectrum liquid antibiotic drug candidate that targets topical treatment of bacterial skin and soft tissue infections, including the reduction of antibiotic-resistant strains. The Company has demonstrated proof-of-principle for enhanced topical drug delivery using hyliQ™ in nonclinical models for all three applications. "We are excited that 3E Bioventures Capital and Beijing Whale Technology Corporation have committed to support Dermaliq as new investors in the Series A round. Our spin-off from Novaliq and successful raising of significant funds provides us with the opportunity to build a leading specialty pharmaceutical company and expand the application of Novaliq's transformative drug delivery technology into dermatology." Dr. Frank Löscher, Chief Executive Officer of Dermaliq "3E is committed to investing in global leading life sciences and biomedical companies and help them grow with access to globalized resources and capabilities," said Karen Liu, Managing Director 3E Bioventures Capital. "Dermaliq is using a unique, and scientifically sound technology to achieve high efficiency drug delivery across the skin. The technology is already proven in ophthalmology and holds great promise for dermatology. We will be excited to explore additional drug pipelines in China and synergize with Dermaliq on both pre-clinical and clinical development." "Whale Technology values the solid science foundation of Dermaliq's proprietary hyliQ™ technology platform," said Ming Gao, founder and Chief Executive Officer of Whale Technology Co. Ltd. "Dermaliq's founding team demonstrates a great combination of science, clinical experience and commercialization strength. We see great potential of Dermaliq's pipeline in the field of dermatology after Novaliq's proven clinical and commercial success in ophthalmology." "Dermatology is the logical next step into using Novaliq's proprietary technology platform outside eye care," said Dr. Christian Roesky, Chief Executive Officer Novaliq. "The spin-off into an independent company allows Dermaliq to greatly benefit from our experience in ophthalmology while being fully committed to the multiple product development activities in dermatology, and likely to further broaden its pipeline to other skin conditions." To reflect the new shareholder structure, Karen Liu of 3E Bioventures Capital will join Dermaliq's Board of Directors. Dr. Löscher has also transitioned from his role as Chief Technology Officer at Novaliq to lead Dermaliq as its CEO & President. About Dermaliq Dermaliq Therapeutics, Inc. is a private company founded in 2021 through a spin off from Novaliq to reimagine topical dermatology. The Company is incorporated in Wilmington (DE), USA under Delaware law. The company has signed a USD 15 million series A round to advance three transformative skin care drug therapies through clinical trials. Key shareholders are Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd. About 3E Bioventures Capital 3E Bioventures Capital is a healthcare venture capital firm, dedicated to investing in cutting-edge life sciences and biomedical technologies, with a focus on breakthrough first-in-class therapies and disruptive cross-disciplinary innovations in medical devices and diagnostics. 3E Bioventures takes on a science-driven, entrepreneur-friendly investment philosophy by working closely with companies and research institutions to develop drugs or products that have strong unmet medical needs. With offices in Beijing, Shanghai, and the San Francisco Bay Area, 3E Bioventures leverages its experience, capabilities, and network to help companies tap into markets and resources across the Pacific and advance with greater speed and capital efficiency. The motto of 3E Bioventures Capital is captured in its name 3E: Expertise, Efficiency, Execution. About Beijing Whale Technology Corporation Ltd Beijing Whale Technology Corporation Ltd. is a China-based pharmaceutical group committed to the long-term sustainable development in the fields of chemistry, pharmaceuticals and aesthetics. With more than 20 years of history, Whale Tech. has developed two core business units. On one hand, Whale Pharmaceutical Co. Ltd., Whale Chemistry Co. Ltd. and Whale Pharmatech Co. Ltd. are grouped as pharmaceutical and chemistry business unit. On the other hand, Whale Biotech is a research stage biotech company with the focus of developing aesthetics products. About Novaliq Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free eyedrop technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies.

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BUSINESS INSIGHTS

Omnicell Completes Acquisition of ReCept

Omnicell, Inc. | December 30, 2021

Omnicell, Inc. a leading provider of medication management solutions and adherence tools for health systems and pharmacies, has completed the previously announced acquisition of ReCept Holdings, Inc. The addition of ReCept’s specialty pharmacy management services for health systems, provider groups, and federally qualified health centers expands Omnicell’s Advanced Services portfolio to address the growing and complex specialty pharmacy market. ReCept provides implementation and managed services for health systems and other provider organizations to optimize their specialty pharmacy programs and the related pharmaceutical aspects of patient care. This total solution supports on-site management, including payor contracting, staffing, licensing, quality assurance, 340B administration, and preferred pricing agreements designed to improve margin and profitability, while keeping the patient at the center of care. “ReCept’s specialty pharmacy management services capabilities naturally complement Omnicell’s intelligent infrastructure, giving us deeper expertise to address the growing market need for managing complex specialty medications as part of a broader, more comprehensive medication management strategy,” Randall Lipps, chairman, president, CEO, and founder of Omnicell Under the terms of the purchase agreement, the acquisition price was $100 million, subject to customary adjustments, as provided for in the agreement and plan of merger. The ReCept business that is being acquired recorded annual recurring revenue of $24 million (unaudited) for the 12 months ended September 30, 2021, and is expected to accelerate Omnicell’s Advanced Services revenue growth. Omnicell used cash on its balance sheet to fund the transaction, which is expected to be accretive to Omnicell’s non-GAAP EBITDA beginning in the first quarter of 2023. About Omnicell Since 1992, Omnicell has been committed to transforming the pharmacy care delivery model to dramatically improve outcomes and lower costs. Through the vision of the autonomous pharmacy, a combination of automation, intelligence, and technology-enabled services, powered by a cloud data platform, Omnicell supports more efficient ways to manage medications across all care settings. Over 7,000 facilities worldwide use Omnicell automation and analytics solutions to help increase operational efficiency, reduce medication errors, deliver actionable intelligence, and improve patient safety. More than 60,000 institutional and retail pharmacies across North America and the United Kingdom leverage Omnicell's innovative medication adherence and population health solutions to improve patient engagement and adherence to prescriptions, helping to reduce costly hospital readmissions.

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PHARMACY MARKET

KromaTiD Announces Launch of KromaTiD Pinpoint FISH TP53/CEP17 Kit for Synthetic Oligonucleotide-Based FISH Assay

KromaTiD Inc | January 14, 2022

KromaTiD is excited to announce early access to our KromaTiD Pinpoint FISH TP53/CEP17 Kit, our new product designed to supply the highest resolution, lowest background, and lowest limit of detection available. KromaTiD's Pinpoint FISH™ Kit, allows for better hybridization conditions and eliminating strand degradation steps. Pinpoint FISH™ allows researchers to expand beyond the capabilities of conventional FISH probes to detect smaller targets and design ultra-high specificity tests. Our technology is fully compatible with your standard FISH equipment/conditions and BAC probes and works with your established samples, workflow, and imaging system. "Single-cell genomic measurements from KromaTiD have unique capabilities to analyze and understand the underlying genomic drivers of human disease. Pinpoint FISH has an unmatched resolution, extraordinary ease of use, consistency from analysis to analysis, and an unprecedented ability to distinguish fine genomic structural variation" Dr. Tompkins continues, "While this is the first catalog product from KromaTiD, we have a ten-year history of building a custom assay for Pharma and Biotech companies based on the PPF and dGH platforms. As we begin to build out a comprehensive line of blood cancer measurement kits, we are delighted to bring Pinpoint FISH to a worldwide market". Pinpoint FISH™ is available now from KromaTiD for researchers' use in oligonucleotide-based FISH assays. Christopher Tompkins, KromaTiD's Chief Technology Officer About KromaTiD, Inc. KromaTiD is transforming the fields of genome engineering through the discovery and characterization of genomic structural changes that help leading gene editing and pharmaceutical companies advance therapies to market. KromaTiD offers a powerful suite of products and services for studying genomic rearrangements, custom assay development services and preclinical research support. KromaTiD's proprietary Pinpoint FISH™ and directional Genomic Hybridization platforms (dGHTM) have applications throughout genomics, supplying direct, definitive data on structural variations that no other technologies can provide. We provide the essential genomic structural context to sequence.

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Spotlight

Katherine Bakshian Chiappinelli, Ph.D., joined the GW Department of Microbiology, Immunology and Tropical Medicine University in 2017 as an Assistant Professor.Dr. Chiappinelli graduated with a B.S. in Biology and Music from Haverford College in 2007 and received her Ph.D. in Developmental, Regenerative, and Stem Cell Biology from Washington University in St. Louis under the supervision of Dr. Paul Goodfellow in 2012. Dr. Chiappinelli pursued postdoctoral studies at Johns Hopkins University with Dr. Stephen Baylin investigating the epigenetic control of immune signaling in cancer cells. Her research focuses on how epigenetic therapies can be used against cancers, specifically in the context of arming the host immune system to fight cancer cells.

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