Teva expands blood pressure drug recall in the US amid cancer fears

Pharmaphorum | June 14, 2019

Teva has expanded a recall of losartan potassium tablets after tests revealed a potential human carcinogen in the blood pressure drug. The Israeli pharma earlier this week recalled six lots of the drug containing unacceptable levels of a nitrosamine impurity. This builds on a decision in April when Teva withdrew 35 lots after detecting the same impurity known as NMBA (N-Nitroso-N-methyl-4-aminobutyric acid). According to a recall notice shared by the FDA, Teva had sold bulk lots of the drug to California-based Golden State Medical Supply. The bottles were in sizes containing 30, 90 or 100 tablets. People affected by the recall should continue taking their drugs and ask a doctor or pharmacist about alternatives or replacements, the FDA said. This is because stopping the medication without replacement could cause more harm than continuing with the treatment course. Teva needs to maximise its revenues to pay off huge debts it incurred when it acquired Allergan’s generics business in 2016 for $40.5 billion. The company posted a loss for the first quarter of the year of $97 million, compared with a $1.1 billion profit in the first quarter of 2018.

Spotlight

The following situation is typical for many production plants: After a routine quality check, the production process is stopped or an already produced batch is suspended because the analysis results were not within the relevant critical values. But does the tested product really deviate from the specifications? The quality control managers are convinced of this because modern analysis instruments provide results with very low tolerances. The sample in question was tested several times and the result was confirmed. The question is why the product does not match the specifications although the production parameters have not been changed in any way.


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PHARMACY MARKET

Vivera Partners with NINDS of NIH to Identify Potential Stuttering Treatments

Vivera Pharmaceuticals, Inc. | May 18, 2022

Vivera Biosciences, a division of Vivera Pharmaceuticals dedicated to the research and development of innovative medical technologies and pharmaceutical therapies, is pleased to announce its collaborative progress on a Cooperative Research and Development Agreement with the National Institute of Neurological Disorders and Stroke an Institute within the National Institutes of Health that aims to foster and advance cutting-edge neuroscience research to reduce the burden of neurological disease. The collaboration aims to identify therapeutic agents for the potential treatment of stuttering disorders, estimated to affect approximately 70 million people worldwide. Stuttering, also referred to as childhood-onset fluency disorder, is a neurological condition characterized by speech disfluencies, which can be disabling to patients affected. While there are currently no FDA-approved therapies for stuttering, in recent years, much has been discovered to understand the underlying neurological basis for the disorder. Scientists at Vivera and NINDS have discovered differences in the structure and function of the areas of the brain that regulate the timing and initiation of speech related to stuttering. These neurological revelations and the potential to develop related therapeutics inspired the partnership between Vivera and NINDS. The initiative is unique because of the individuals it will be led by: Vivera Biosciences' Investigator, Gerald A. Maguire, M.D., D.F.A.P.A., and NINDS' Principal Investigator, Shahriar SheikhBahaei, Ph.D. Both are persons who stutter and doctors who have dedicated their careers to understanding the disorder they share with millions of others and one they are working to develop novel treatments for. "I am grateful to the NIH, NINDS, and Vivera Biosciences for supporting this translational collaborative research with my friend and colleague, Dr. SheikhBahaei, as we potentially develop therapeutics to assist our stuttering community," said Dr. Maguire. Dr. Maguire is a world-renowned clinical researcher. He has over three decades of experience as an academic psychiatrist and has served as principal investigator for numerous studies involving investigational medications for various neuropsychiatric disorders, specializing in stuttering. "This collaboration may be an initial step toward developing novel and personalized therapeutic approaches for changing the course of the disorder for people who stutter," Dr. SheikhBahaei. Dr. SheikhBahaei's graduate studies focused on how astrocytic networks control activities of respiratory motor circuits within the brainstem. He currently leads the Neuron-Glia Signaling and Circuits Unit at NINDS, whose goal is to understand how different glial and neural cell types in the brain contribute to the neural circuits controlling voluntary speech production to enhance the ability to intervene in motor control disorders like stuttering. "Vivera is confident in our choice in partnership with NIH," said Vivera's Chief Medical Officer, Stephen J. McColgan, M.D., M.B.A. "Since day one, Vivera has been dedicated to the research and development of patient-centric treatments," said Paul Edalat, CEO of Vivera. "This partnership with NIH and NINDS is about bettering the lives of people who stutter, further solidifying the Company's commitment to our mission." About Vivera Pharmaceuticals Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH®, a smart dose-controlled electronic medical device. The Company has also received a Notice of Allowance for its portable telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.

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PHARMACY MARKET

IAMA Therapeutics Partners with the Italian Institute of Technology to Embark on Landmark Research on Neuroscience Drug Discovery

IAMA Therapeutics | March 31, 2022

IAMA Therapeutics, a Series A preclinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel medicines to make a difference in the lives of individuals suffering from brain disorders, today announced a strategic collaboration with the IIT-Istituto Italiano di Tecnologia where they will design and profile new classes of compounds targeting cation cotransporters in the CNS area. This partnership consolidates a scientific collaboration between IAMA Therapeutics and IIT, which signed, together with the Telethon Foundation earlier in 2021, a license agreement, granting IAMA therapeutics an exclusive, worldwide license to research, develop, manufacture, and commercialize a novel class of modulators of intracellular chloride concentration. "We are pleased with and excited by this partnering opportunity with IAMA Therapeutics, a clear example of IIT technology transfer approach. We are setting the Italian way of producing science and tech-based innovation, where the collaboration among brilliant researchers, important founding agencies like Fondazione Telethon, and investors creates the right ecosystem enabling new businesses to emerge." Dr. Matteo Bonfanti, Director of Technology Transfer at Istituto Italiano di Tecnologia "We are very happy for the partnership between IAMA Therapeutics and IIT," said Francesca Pasinelli, General Manager of Fondazione Telethon. "This collaboration is based on innovative science, which was selected and nurtured earlier on by Fondazione Telethon. As part of our focus on fostering development, we funded the project and supported researchers through the technology transfer process together with IIT. Now, this promising research avenue is accessing the resources and competencies necessary to take and accelerate the long and expensive path to patients. It shows what can be accomplished through a timely and coordinated effort to maximize research impact". About IAMA Therapeutics IAMA Therapeutics is a pharmaceutical company that couples emerging advances in drug discovery and neurobiology to build a leading, next-generation neuroscience pipeline. We have developed a platform to identify and advance diverse classes of small molecules to selectively inhibit the sodium potassium chloride cotransporter and other therapeutic targets relevant to treating central nervous system disorders characterized by neuronal imbalance, including primary and secondary autism, epilepsy, and movement disorders. About Istituto Italiano di Tecnologia Istituto Italiano di Tecnologia is a foundation established jointly by the Italian Ministry of Education, Universities, Research, and the Ministry of Economic and Finance to promote excellence in basic and applied research and contribute to Italy's economic development. The primary goals of the IIT are the creation and dissemination of scientific knowledge and the strengthening of Italy's technological competitiveness. To achieve these two goals, the IIT cooperates with academic institutions and private organizations, fostering scientific development, technological advances, and training in high technology. About Fondazione Telethon Fondazione Telethon is a major biomedical charity in Italy whose mission is to advance biomedical research to cure rare genetic diseases. Throughout its 32 years of activity, Fondazione Telethon has invested almost €600 million in funding over 2,700 projects to study 580 diseases, involving more than 1,600 researchers in Italy. As part of its goal to foster development and maximize the therapeutic impact of research, Fondazione Telethon further pursues cooperation with academia, industry, and venture capital through the creation of partnerships and start-ups.

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BUSINESS INSIGHTS

Vetsource Expands Its Solution Set to Include Data and Insights, Client Engagement

Vetsource | February 28, 2022

Vetsource®, a pet health company that provides innovative pharmacy, technology and business services designed to help customers provide products and services to those who care for pets, has added data and insights, and client engagement offerings to its portfolio of customer solutions. Previously focused primarily on the home delivery of prescription and nonprescription items on behalf of veterinary practices, Vetsource has expanded its services in order to build a world-class infrastructure to help its veterinary practice, industry and retail customers deliver a competitive and personalized experience for their clients. The portfolio expansion is the result of Vetsource's investment in two companies – VetSuccess and Vet2Pet – as part of a long-term strategy to continue to meet the needs of its customers, and ultimately pet owners. "As the veterinary market has evolved, we've recognized the need to expand our solution set to help our customers engage with their clients in meaningful ways and leverage data to improve compliance rates and revenue. These services are a natural complement to our prescription management solution," Kurt Green, Vetsource CEO As the industry's leading data experts, VetSuccess provides performance reports, dashboards, and data services to veterinary practices, as well as robust analytics and quantitative veterinary insights to industry partners. These intuitive and interactive solutions allow customers to gain a deeper understanding of business performance, uncover actionable insights and make confident decisions that improve day-to-day operations. "With our strong alignment on company culture and core values, VetSuccess is a natural fit to join forces with Vetsource," said Katie McClean, Managing Director of VetSuccess. "We're proud to apply our expertise to help Vetsource deliver a data-driven platform that simplifies workflows and fosters growth for veterinary practices, ultimately providing the solutions partners need to break barriers and build bridges that strengthen the human-animal bond." Vet2Pet offers veterinary medicine's only customizable, all-in-one client connection system and app. Features like appointment management, pharmacy refills, 2-way chatting and texting, reminders, and rewards programs make it easy for practices and pet owners to interact, increase practice revenue, and save staff an average of three hours of phone time each day. "Joining Vetsource will help us achieve the dream we've had for Vet2Pet since its inception. Veterinarians will now have access to sophisticated software that elevates the client experience, improves team efficiency, and helps practices retain their pharmacies. This is a win for everyone," said Dr. Stacee Santi, Managing Director of Vet2Pet. In addition to product development, Vetsource has made significant investments in its workforce, leadership, and pharmacy operations, including the addition of a new pharmacy on the East Coast in 2021. Over the last three years, Vetsource has focused on building the teams that will drive products forward by more than doubling its workforce, including a deep investment in engineering talent. Vetsource recently hired Chief Product Officer, Ami Murthy, who brings extensive experience in product management and consumer ecommerce from leadership roles at companies such as eBay and Amazon. "Our dedication to providing a powerful platform is demonstrated not only in the investments we have made in enhancing our products, but also in the expertise of our teams," added Green. "After more than a decade as a pioneer in this market we want to continue to lead the way and we're just getting started." About Vetsource Vetsource provides innovative pharmacy, technology and business services to the pet health industry. At Vetsource, we strive to be the most trusted advocate in a rapidly evolving world and constantly seek new ways to help our customers chart a course for a better, brighter future for pets and their caretakers. Our data-powered platform eliminates complexities and simplifies workflows to help veterinarians, retailers and others in the pet health industry foster engagement, loyalty and positive experiences that ensure strong relationships. Vetsource's solutions include prescription management, data and insights, and client engagement. Founded in 2008 to help veterinary practices compete in the online marketplace with a home delivery solution, Vetsource expanded with the acquisitions of VetSuccess and Vet2Pet. Comprising over 500 employees, Vetsource is headquartered in Portland, Ore., with additional offices in Colorado, Oklahoma, Pennsylvania and Toronto, as well as multiple pharmacy locations.

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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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Spotlight

The following situation is typical for many production plants: After a routine quality check, the production process is stopped or an already produced batch is suspended because the analysis results were not within the relevant critical values. But does the tested product really deviate from the specifications? The quality control managers are convinced of this because modern analysis instruments provide results with very low tolerances. The sample in question was tested several times and the result was confirmed. The question is why the product does not match the specifications although the production parameters have not been changed in any way.

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