Emcure injected schizophrenia drug recalled after contamination detected

fiercepharma | May 28, 2019

Two injected drugs manufactured by an Indian company with a history of sterility problems are being recalled because of microbial contamination. The drugs were both manufactured by Emcure Pharmaceuticals but are distributed in the U.S. by Heritage Pharmaceuticals.East Brunswick, New Jersey-based Heritage Saturday issued the voluntary recall to the consumer level for sublots of infection fighter amikacin sulfate injection and schizophrenia drug prochlorperazine edisylate after microbial growth was found in unreleased supplies of the products.The company warned that patients injected with either of the drugs could get site-specific or even systemic infections that could lead to hospitalization and death. The company said no adverse reactions have been reported so far.Amikacin sulfate injection is for the short-term treatment of serious infections from a variety of species of gram-negative bacteria. Prochlorperazine edisylate injection is indicated to control severe nausea and vomiting and for the treatment of schizophrenia.The recall does not say which Emcure facility manufactured the products. In 2015, the FDA bannednearly all products coming out of Emcure's sterile manufacturing plant in Hinjawadi, India, and then followed up with a warning letter for the facility. The agency whipped the drugmaker for routinely using "fraudulent" test data to move drugs through the manufacturing process.The agency then patted the company on the back for turning to consultants to help it solve its problems and changing some procedures and retraining employees. However, the FDA pointed out the facility should have known better because it had been previously warned about practices that could lead to drug contamination.

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Watch Jon Sutch, PhD, Senior Manager, Formulation Development and Sanjay Konagurthu, PhD, Senior Director, PDS Global Science & Technology, both with Patheon, as they evaluate how spray drying techniques can be leveraged to address low solubility challenges in drug development.


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Long Island University Extends Partnership with Dassault Systèmes to Innovation and Research in Life Sciences

Long Island University | March 23, 2022

Long Island University announced a new research and innovation partnership with Dassault Systèmes in life sciences. The partnership will focus on research with high societal impact to advance the fields of pharmaceutical sciences, precision medicine and health care in the digital age. Research includes precision medicine using "Virtual Twins," or exact digital models of human anatomy being developed by LIU and Dassault Systèmes; pandemic preparedness and the digitization of healthcare; innovation in medical devices; and telemedicine through the "Internet of Things," or the exchange and analysis of data between physical objects that are connected digitally. In addition, the partnership aims to provide a platform for technology transfer, or the sharing and transformation of inventions and scientific outcomes into commercialized products or services that benefit society. "Long Island University is at the forefront of revolutionizing health care training and research in higher education with our ongoing partnership with Dassault Systèmes. We are investing in opportunities and technology to ensure our students become future leaders and innovators in emerging industries." President Kimberly R. Cline As part of this commitment to students, LIU has also been designated as a Dassault Systèmes 3DEXPERIENCE Edu Center of Excellence. Dassault Systèmes created the global 3DEXPERIENCE Edu Centers of Excellence program in October 2021. The program is aimed at providing students, professionals, learners, businesses and governments with a network of centers dedicated to experiential, lifelong learning with its 3DEXPERIENCE platform that enables the current and future workforce to accelerate the digital transformation of industry. "At Dassault Systèmes, we have the profound belief that the virtual world extends and improves the real world helping to address today's social and environmental challenges," said Rama Kondru, Ph.D. co-CEO of Medidata, a Dassault Systèmes company. "This strategic initiative with LIU brings enormous opportunities since it is helping to prepare the next generation of life science experts to innovate in tomorrow's more sustainable economy, transform healthcare, and solve some of the biggest medical challenges in areas such as cancer and Alzheimer's disease." LIU is the second Center of Excellence in the U.S. in addition to Purdue University, which opened as a Center of Excellence in Advanced Composites in 2020. Additional centers have been established in France, Mexico, Germany, Switzerland, Brazil and India, and focus on various industry sectors. "Earning the distinction of being named a 3DEXPERIENCE Edu Center of Excellence is a testament to Long Island University's standing as a preeminent academic institution," said LIU Board of Trustees Chair Eric Krasnoff. "We are proud to partner with Dassault Systèmes to create an ecosystem where students, faculty and industry partners can collaborate on real-world, impactful learning." The University's extended and ongoing partnership with Dassault Systèmes, world leader in 3D design and engineering software, is in line with its vision to advance academic excellence through innovation, provide extraordinary and distinctive experiences to students, and create solutions for a sustainable global future. Forged in 2019, the partnership provides LIU students with hands-on experience using cutting-edge artificial intelligence and digital engineering technologies, and to collaborate on multidisciplinary research in the life sciences. "The LIU-Dassault Systèmes research partnership is centered on solving real-world problems through an integrated approach to education while simultaneously developing the future workforce for precision medicine, healthcare and pharmacy," said Dr. Randy Burd, senior vice president for academic affairs at LIU. "We look forward to using Dassault Systèmes' incredible technology to expand and enhance life sciences, liberal arts, humanities and performing arts degree programs throughout the University." In 2021, the University opened a state-of-the-art simulation laboratory that allows students to use Dassault Systèmes' patented 3D, augmented reality and virtual reality software to conduct experiential research, education and training. The laboratory is used in several areas of study, including artificial intelligence, robotics, virtual reality gaming, cybersecurity, data analytics, and drug discovery and development. LIU also employs Dassault Systèmes' cloud-based 3DEXPERIENCE platform in classrooms across the University. "LIU has entered a truly transformative niche in higher education by aligning with a digital healthcare industry that is on the rise," said Dr. Mohammed Cherkaoui, vice president for academic affairs at LIU. "We are honored to work with Dassault Systèmes, combining its content expertise and research tools to become a global leader in the innovation of healthcare." About Long Island University Long Island University, founded in 1926, continues to redefine higher education, providing high quality academic instruction by world-class faculty. Recognized by Forbes for its emphasis on experiential learning and by

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Treatment to Expand Global Library of Medicine with Dermatologic Diseases

Treatment.com International Inc. | January 05, 2022

Treatment.com International Inc. a healthcare AI technology company, has entered into a research project agreement with the University of Minnesota to add more than 220 dermatologic diseases to their proprietary, responsive AI engine known as the Global Library of Medicine (GLM). The addition of these diagnoses will bring another level of accuracy and specificity to the GLM, enhancing soon-to-be-released products such as the Treatment Mobile app, which is set for release this month. Kevin A. Peterson, MD, MPH, FRCS(Ed), FAAFP and Chief Medical Officer of Treatment, says, “Engaging in research with the University of Minnesota Dermatology department brings extensive academic medical expertise that enhances our ability to provide richly detailed descriptions of dermatologic concerns. The rich experience of the University of Minnesota Medical School will help the GLM provide more accurate descriptions of complex presentations of skin diseases. Combining our advanced AI infrastructure with the rich clinical and research expertise of the Medical School will substantially enhance our AI platform’s ability to provide better access to high quality information and directly supports the mission of the GLM to enhance health outcomes for individuals around the world.” “We are proud that the University of Minnesota is participating with us on this latest research project, which is in addition to other mutually beneficial agreements we’ve entered into with the University. The Global Library of Medicine is one way we are realizing Treatment’s plan to provide the most accurate and reliable data about health concerns, made available to clinicians, organizations, and patients alike.” John Fraser, Treatment’s CEO The Global Library of Medicine is the foundation of Treatment’s Clinical solutions, which offer unique ways to bring healthcare into the digital age by providing better access to up-to-the-minute healthcare information and promoting better health outcomes around the world. Treatment Mobile and the intelligent digital assistant will be released in select North American clinics in 2022. About Treatment.com Treatment.com is a disruptive healthcare technology company that is harnessing the power of AI to help global citizens improve their health through personalized recommendations and insights. Based in Vancouver with a US subsidiary, the company spent the last five years working with a team of world-class doctors, engineers, mathematicians, and AI specialists to develop a complex AI engine that leverages the most robust, personalized data to generate highly predictive and accurate insights. Treatment.com is the parent company of Treatment Mobile, and an intelligent digital health assistant which will empower people to take control of their health through an innovative mobile app, powered by Treatment’s exclusive AI engine.

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Angelini Pharma, a New Partner in Epilepsy

Angelini Pharma | March 26, 2022

On the occasion of Purple Day an annual international event aimed at raising awareness of epilepsy, Angelini Pharma, international Italian pharmaceutical company, is committed to provide patients and healthcare professionals with innovative solutions improving the care of patients with epilepsy. Epilepsy is a common neurological disorder that typically results in seizures of various types, with focal seizures being the most common one.1 The essential treatment goal of epilepsy therapy is seizure freedom.2 The global disease burden of epilepsy is high. 3,4 A diagnosis of epilepsy confers significant disability on the individual, including physical, psychological, and social issues that negatively impact self-esteem, family environment, relationships, leisure and working life. 3,5 Long-term outcomes for patients who have not responded to at least 2 antiepileptic drugs remain without significant improvement for more than 2 decades despite the availability of many new antiepileptic drugs. 6,7 Indeed, even today 40% of all patients with epilepsy do not achieve seizure freedom despite treatment with 2 different drugs.6,8 The probability of achieving the therapeutic goal of seizure freedom decreases significantly with each failed treatment. 6 Aware of the existence of an unmet medical need, Angelini Pharma is committed to make available a new anti-epileptic drug. The product received the Market Authorization from the European Medicines Agency in March 2021 and many Early Access Program authorization across European countries, including in France. The product is already marketed in Germany, Austria, United Kingdom, Sweden, and Denmark. About Angelini Pharma Angelini Pharma is an international pharmaceutical company, part of the Italian privately group owned Angelini Industries. Angelini Pharma is committed to helping patients in the therapeutic areas of Mental Health Rare Diseases and Consumer Healthcare. In particular, Angelini Pharma is committed to brain health working every day to reduce and mitigate neurological disorders, while restoring and protecting mental health and cognitive function.

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New Interactive App From rXperius Set to Provide Pharma Industry with Vital Patient Experience Insights

rXperius | February 16, 2022

Patients can now provide pharmaceutical manufacturers with real-time feedback on prescription medicines they are taking following the launch of a new app by rXperius, a Raleigh, NC-based company that specializes in the design of innovative technology platforms. The MedXer app, which can be downloaded from the Apple and Google app stores, is the first prescription survey app that allows patients to give feedback on their medications in real time, and over time. MedXer pays patients for their experiences. The insights collected by the app will support the pharmaceutical industry’s efforts to further improve patients’ lives by providing actionable data on patients’ individual experiences. MedXer is designed to complement other data analytics on consumer insights that drugmakers are already collecting. “We know how hard it can be for pharma to reach their true end users – patients. Pharmaceutical companies only receive direct feedback from a limited number of patients. Often, they have to rely on second- or third-hand information to gain any kind of understanding of patients’ medicines experiences. MedXer will bring the patients’ story to the manufacturer in a dynamic and actionable way,” Steve Castillo, Founder of rXperius Pharmaceutical companies will have access to an interactive dashboard that is updated daily to reflect the latest information collected through the app. All patient data is anonymized and aggregated before it is shared with third parties. The stakes for the pharmaceutical industry are high; manufacturers only have around five to seven years to recover the money they invest in bringing a medicine to market. A company will typically spend around $3.5 billion developing and launching a drug, but 40 percent of recent drug launches have failed to achieve a return on investment. Since the launch of MedXer on January 1, approximately eight percent of people who have viewed the app have downloaded it, above market trends of 1-2%. MedXer, which is currently available for migraine and depression medications, will be expanded to include medicines from other disease areas following completion of the initial launch phase. About rXperius rXperius is a data analytics startup that was established in 2019 by veterans of the pharmaceutical industry with a combined pharma experience of more than 100 years. rXperius was incorporated in Delaware in 2020 with HQ in Raleigh, NC.

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Spotlight

Watch Jon Sutch, PhD, Senior Manager, Formulation Development and Sanjay Konagurthu, PhD, Senior Director, PDS Global Science & Technology, both with Patheon, as they evaluate how spray drying techniques can be leveraged to address low solubility challenges in drug development.

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