New prostate cancer test could diagnose five years earlier

Pharmatimes | June 27, 2019

New prostate cancer test could diagnose five years earlier
Researchers at the University of East Anglia and the Norfolk and Norwich University Hospital have developed a urine test, dubbed PUR (Prostate Urine Risk), to diagnose aggressive prostate cancer and predict whether patients will require treatment up to five years earlier than standard clinical methods. The revolutionary test also identifies men who are up to eight times less likely to need treatment within five years of diagnosis. The University says that it hopes the breakthrough “could help large numbers of men avoid an unnecessary initial biopsy and repeated invasive follow-ups for 'low risk' patients on active surveillance.” Previous urine biomarker tests have been designed specifically for single purposes such as the detection of prostate cancer on re-biopsy (PCA3 test). But, this new test uses four PUR signatures to provide a simultaneous assessment of non-cancerous tissue and risk groups (low, intermediate and high-risk) to show how aggressive the cancer is. Lead author Shea Connell from UEA’s Norwich Medical School, explained that “Prostate cancer is more commonly a disease men die with rather than from. Unfortunately, we currently lack the ability to tell which men diagnosed with prostate cancer will need radical treatment and which men will not. “Current practice assesses a patient’s disease using a PSA blood test, prostate biopsy and MRI. But up to 75% of men with a raised PSA level are negative for prostate cancer on biopsy. Meanwhile 15% of patients who do not have a raised PSA are found to have prostate cancer – with a further 15% of these cancers being aggressive.

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PHARMA TECH

Milestone Scientific Names Andau Medical as an Additional Distributor for the STA Single Tooth Anesthesia System® in North America

Milestone Scientific, Inc. | December 24, 2021

Milestone Scientific Inc. a leading developer of computerized drug delivery instruments, that provide painless and precise injections, announced it has entered into an agreement with Andau Medical to distribute the STA Single Tooth Anesthesia System® in the United States and Canada. Arjan Haverhals, CEO of Milestone Scientific, stated, “We are pleased to announce the addition of Andau Medical to our growing roster of distributors for the STA Single Tooth Anesthesia System in the United States and Canada. We initially began our collaboration with Andau around our CompuFlo® Epidural Instrument in Canada. In addition to medical devices, they have a strong track record introducing dental instruments to the market, which we believe will help further fuel the strong momentum we’re experiencing within our dental division.” “We are excited to expand our existing partnership with Milestone Scientific by introducing the STA Single Tooth Anesthesia System through our broad network of dentists and hygienists across North America. The STA offers significant benefits to both patients and clinicians through painless injections, shorter wait times for anesthesia, fewer complications, and reduced patient cancellations. This enables dentists to grow their businesses while improving the patient experience.” Sandi Wright, Founder and CEO of Andau Medical About Andau Medical Andau Medical is a Medical Device and Dental Device company focused on providing U.S. and Canadian markets with quality technologies that improve patient outcomes and enhance the clinical experience in delivering exceptional patient care. Andau has expertise in sales, marketing, regulatory and distribution, thereby enabling quick market uptake of both existing and new technologies. About Milestone Scientific Inc. Milestone Scientific Inc. a technology focused medical research and development company that patents, designs and develops innovative injection technologies and instruments for medical, dental and cosmetic applications. Milestone Scientific’s computer-controlled systems are designed to make injections precise, efficient and increase the overall patient comfort and safety. Their proprietary DPS Dynamic Pressure Sensing Technology® instruments is the platform to advance the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions of subcutaneous drug delivery, including local anesthetic.

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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

Arrowhead Initiates Project to Build New Manufacturing and Lab Facilities

Arrowhead Pharmaceuticals | December 21, 2021

Arrowhead Pharmaceuticals, Inc. announced that it has completed a transaction to purchase 13 acres of land in the Verona Technology Park in Verona, WI, which is planned to be the site of an approximately 140,000 square foot drug manufacturing facility and an approximately 115,000 square foot laboratory and office facility to support process development and analytical activities. Arrowhead intends to invest between $200 million and $250 million into the buildout of the facilities. The Company expects that the new facilities will result in the creation of approximately 250 new jobs in the local area. Construction is scheduled to begin in the first quarter of 2022. Arrowhead will continue to operate additional research and development facilities in Madison, WI, and San Diego, CA. “For more than a decade, Arrowhead has been a dedicated member of the biotech community in the greater Madison, Wisconsin, area. We have built strong local relationships and are pleased to continue our growth with the new Arrowhead campus that will include a new GMP manufacturing facility and associated lab and office facility. This investment reaffirms our commitment to the Wisconsin biotech ecosystem, and we would like to thank the local agencies, who have been a pleasure to work with. Arrowhead’s pipeline of what we believe are industry leading investigational RNAi medicines continues to expand rapidly. The new Arrowhead campus will allow us to support our growing pipeline and positions us well to advance the manufacturing process, including at commercial scale, of our TRiM™-enabled drug candidates. We view this as a strong competitive advantage as we approach potential commercialization of our rapidly progressing clinical candidates.” Christopher Anzalone, Ph.D., Arrowhead’s president and CEO Major project team members include Eppstein Uhen Architects, DPS Group, D’Onofrio Kottke & Associates, Smocke & Associates, Cresa Madison, and Vogel Brothers Building Company. John Chapman, Vice President and Design Principal at EUA, said, “We are privileged to be collaborating again with Arrowhead on an inventive building design which will enable their employees to treat some of the most challenging diseases.” Completion of the lab and office space is anticipated in the first quarter of 2023 and completion of the manufacturing facility is expected in the fourth quarter of 2023. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

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RESEARCH

DisperSol Technologies Announces Collaboration with Ajax Therapeutics to Develop Enhanced KinetiSol Drug Formulations

DisperSol Technologies | December 18, 2021

DisperSol Technologies LLC announced that it is has entered into a research collaboration with Ajax Therapeutics, Inc. to apply its KinetiSol technology to enhance the bioavailability of an Ajax drug candidate in development for the treatment of hematologic malignancies. “Ajax is taking an innovative approach to developing a pipeline of selectively targeted small molecules and we look forward to applying our proprietary KinetiSol technology to help enhance the bioavailability of one of these promising drug candidates. This collaboration is another example of our partnering strategy with our KinetiSol technology platform to help improve the bioavailability of next generation targeted therapies to provide new treatments for patients in need.” Dr. Edward Rudnic, CEO of DisperSol Technologies About DisperSol Technologies DisperSol is a clinical-stage drug development company focused on developing new treatments for patients utilizing its proprietary KinetiSol® technology platform. KinetiSol has proven capable of creating novel therapeutics from poorly bioavailable drugs to deliver unique clinical benefits to patients. The platform enables a drug development path forward to patients when other options fail to make a difference. DisperSol’s active programs include, DST-0509 about to enter Phase 3 for iron overload disorder and DST-2970 in Phase 2 for refractory metastatic prostate cancer. Additional earlier-stage programs include DST-5407 for non-squamous non-small cell lung cancer. About Ajax Therapeutics Ajax Therapeutics, Inc. is pursuing uniquely selective approaches to develop novel therapies targeting key cytokine signaling pathways that drive hematologic malignancies. By combining the deep cancer and structural biology insights of our founding scientists with the industry’s most advanced computational drug discovery and protein structure platforms from our founding partner, Schrödinger, Inc., we aim to discover and develop more precisely designed therapies to address significant unmet needs for patients with hematologic malignancies.

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