China-US feud forces PatientsLikeMe to find new investor – press

PharmaPhorum | April 05, 2019

Increasingly fraught Sino-American relations are beginning to have a real impact on the health sector, after it emerged that the health networking startup PatientsLikeMe is being forced to find a buyer after the Trump administration ordered its Chinese majority owner to divest its stake. According to CNBC, the divestiture is happening following a review by the Committee on Foreign Investment in the United States (CFIUS), which is aggressively cracking down on Chinese investment in the country. In 2017 the company raised $100m towards its technology allowing patients to link up with people with the same disease and find clinical trials, selling a majority stake to Shenzhen-based iCarbonX, which is in turn by the giant Chinese firm Tencent. Citing several anonymous sources CNBC said it started receiving notifications from the committee last year to try and force a divestiture.

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IAMA Therapeutics Announces Initiation of Preclinical Development Studies in Drug-resistant Epilepsy Under a Service Agreement with Psychogenics

IAMA Therapeutics | July 26, 2022

IAMA Therapeutics, 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, and PsychoGenics Inc., a leader in AI-enabled phenotypic drug discovery and preclinical CRO services, today announced that the companies have entered into a service agreement to identify the efficacy of novel drug candidates in drug-resistant epilepsy. Under the terms of the agreement, PsychoGenics will evaluate the preclinical anti-seizure efficacy of first-in-class selective-NKCC1 inhibitors, which aims to reduce intracellular chloride concentration and restore the physiological hyperpolarizing and inhibitory GABAergic transmission in an animal model of refractory epilepsy. "PsychoGenics is a leader in preclinical behavioral neurobiology with a successful track record of anti-epilepsy drug testing through translational EEG approaches, including electrographic and behavioral identification of seizure. We look forward to leveraging our collective expertise in neuroscience drug development to identify and evaluate the anti-seizure efficacy of new drug candidates, to enhance further and complement our pipeline of differentiated therapeutic opportunities for epilepsy, neurodevelopmental and cognitive disorders." Andrea P. Malizia, Ph.D., MBA, Chief Executive Officer of IAMA Therapeutics “We are excited to embark of these studies with IAMA Therapeutics” said Stephen Morairty, Ph.D., Vice President of Translational Neuroscience at PsychoGenics. “Using our pre-clinical MTLE model, will carefully evaluate the efficacy of these first-in-class selective-NKCC1 inhibitors.” About IAMA Therapeutics IAMA Therapeutics is a preclinical-stage pharmaceutical company focused on discovering, developing, and commercializing novel medicines to make a difference in the lives of children and adults suffering from epilepsy, neurodevelopmental and cognitive disorders. IAMA Therapeutics couples emerging advances in drug discovery and neurobiology to build a leading, next-generation neuroscience pipeline to selectively inhibit the sodium-potassium chloride cotransporter and other therapeutic targets relevant to brain disorders characterized by neuronal imbalance. The company's preclinical pipeline consists of the lead candidate IAMA-6 for the treatment of idiopathic autism, IAMA-097 for the treatment of secondary and rare forms of autism, and other compounds for treating refractory epilepsy and other brain disorders. About PsychoGenics Inc. PsychoGenics is a leader in vivo phenotypic drug discovery. The company applies its proprietary technology platforms in partnership with pharmaceutical and biotechnology companies to discover the next generation of drugs for neuropsychiatric disorders. PsychoGenics' capabilities include standard behavioral testing, electrophysiology, translational EEG, molecular biology, and state-of-the-art microdialysis. In addition, the company offers a variety of in-licensed transgenic mouse models that support research in areas such as Huntington's disease, Autism spectrum disorders, psychosis/schizophrenia, Alzheimer's disease, Parkinson's disease, sleep, and Spinal Muscular Atrophy muscular dystrophy and other muscle disorders.

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Model N and Pfizer Innovate Drug Price Transparency Reporting

Model N, Inc. | August 04, 2022

Model N, Inc. the leader in revenue optimization and compliance, announced the launch of Transparency Talks, a new, three-part education series for pharmaceutical companies that tackles the topic of price transparency regulations for prescription drugs. Transparency Talks will bring together leaders from Model N, Pfizer and Global Pricing Innovations (GPI) to explore state drug pricing laws and regulations, as well as facilitate a discussion on trends, best practices and innovative approaches that help pharmaceutical companies meet regulatory compliance goals. First-Ever SaaS Solution for State Price Transparency Mandates Model N has pioneered a technology-driven approach to state price transparency regulations. Its new State Price Transparency Management (SPTM) solution for the Model N Revenue Cloud is the first-ever SaaS solution built specifically to assist pharmaceutical and biotech companies in operationalizing the complete, end-to-end process for meeting State Price Transparency mandates. “Life sciences companies must find an effective way to prepare and respond to fast-moving changes in state price transparency regulations, and we are excited to deliver innovative solutions to help them avoid costly mistakes. t’s been an honor to partner with Pfizer on State Price Transparency Management, creating an innovative solution that helps navigate the fluid state drug price reporting landscape.” Kyle Forcier, Senior Director of Life Sciences Product Marketing at Model N Pfizer and GPI on SPTM The SPTM solution was developed with the collaboration of Pfizer, the world’s largest pharmaceutical company. “Our collaboration with Model N has delivered a tool that helps us better manage complex state reporting requirements,” said Laura Topal, Senior Director, Strategic Pricing, Pfizer. “We’re proud of what we have achieved together, and we’re excited about sharing our learnings with the larger pharma community.” Rachel Jao, Head of Commercial Strategy from GPI, a market leader in innovative solutions for biopharma and market access, will also join Transparency Talks to share the latest in industry best practices. “More than 20 states have drug pricing transparency laws on the books today, and there can be severe financial consequences for non-compliance,” Jao said. “Transparency Talks from Model N is a valuable way for pharma business leaders to learn more about the current regulatory environment and to explore solutions that will help them address this significant challenge.” About Model N Model N is the leader in revenue optimization and compliance for pharmaceutical, medtech and high-tech innovators. Our intelligent platform powers your digital transformation with integrated technology, data, analytics, and expert services that deliver deep insight and control. Our integrated cloud solution is proven to automate pricing, incentive and contract decisions to scale business profitably and grow revenue. Model N is trusted across more than 120 countries by the world’s leading pharmaceutical, medical technology, semiconductor, and high-tech companies, including Johnson & Johnson, AstraZeneca, Stryker, Seagate Technology, Broadcom, and Microchip Technology.

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Aculys Pharma and SUSMED Have Entered into a Contract to Conduct the World's First Clinical Trial Utilizing Blockchain Technology

Aculys Pharma, Inc. | July 13, 2022

Aculys Pharma, Inc. a company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, has entered into a contract with SUSMED, Inc., a company that promotes digital medicine to conduct the world's first1 corporate-sponsored clinical trial using blockchain technology. The clinical trial utilizing this blockchain technology, provided by SUSMED, will be conducted in collaboration with CMIC Co., Ltd., a pioneer in drug development support (CRO), with the cooperation of several medical institutions. With the sophistication of research and development and the increasing cost of new drug development, improving the efficiency of clinical trials is one of the challenges in the pharmaceutical industry that requires addressing. In such an environment, efficient use of resources and pursuit of efficiency are required. And improving productivity and quality of new drug development is also extremely important for society as a whole. Under these circumstances, Aculys Pharma is working to improve productivity and quality of clinical trials by utilizing AI and digital technologies for the development and commercialization of new drugs. The clinical trial system developed by SUSMED enables the reduction of data entry work and monitoring work2 by medical institutions by using the SUSMED-patented technology that binds e-worksheets and eCRF using blockchain technology. In addition to publishing multiple medical papers3, the clinical research that SUSMED conducted with the National Cancer Center has been approved by the Cabinet Office regulatory sandbox4. The result of the verification test conducted by the regulatory sandbox was published in the International Medical Journal in June 20205. With this outcome, The Ministry of Health, Labor and Welfare issued a notice on December 4, 2020 that source data verification (SDV: Source Data Verification) using blockchain technology is permitted as an alternative method under the GCP ministerial ordinance. CMIC will promote these efforts for attaining an efficient clinical trial by 1) supporting the operation of the system at the medical institution, 2) cooperating with development of the e-worksheet and eCRF, and 3) complementing the functions outside the scope of the system. This clinical trial which utilizes blockchain technology significantly reduces the number of processes around data entry at medical institutions and SDV compared to conventional methods, and also contributes to reducing the number of required CRA visits to the medical institutions. In addition, by taking advantage of blockchain technology, it is expected to have the effect of increasing the reliability of the clinical trial data itself. Through these methods, we aim to improve the efficiency of the clinical trial-related work-streams necessary for new drug development, and to optimize new drug development costs without compromising reliability. "We are delighted to be able to conduct a clinical trial utilizing blockchain technology in collaboration with SUSMED and CMIC as Aculys Pharma strives for providing new therapeutic modalities by making full use of the latest in digital technology. We expect this pioneering effort of three companies, which aim to improve the quality and efficiency of clinical trials, will realize digital transformation of clinical trial monitoring work and contribute to the optimization of new drug development costs. We will continue to actively introduce new technologies not bound by a conventional framework and aim to solve social issues surrounding Japanese healthcare by collaborating and partnering with external partners." Kazunari Tsunaba, President and CEO of Aculys Pharma, Inc Taro Ueno, President and CEO of SUSMED, Inc., stated as follows. "In the clinical trials conducted in the development of new medical technology, prevention of data tampering and cost efficiency have been issues. While developing therapeutic apps in the healthcare field, we have come to focus on the possibility of using blockchain technology in clinical development and continued research and development. This time, we are delighted to be able to collaborate with CMIC to conduct the world’s first clinical trials using blockchain technology in a corporate-sponsored clinical trial of Aculys Pharma, a company that focuses on the development and commercialization of new innovative drugs. We believe that utilization of blockchain technology enables us to realize efficient and reliable clinical development and we also can contribute for optimization and sustainability of future social security.” "CMIC was established in 1992 as Japan's first CRO and has supported a number of clinical trials of drug development. This time we are participating in the corporate-sponsored clinical trial of Aculys Pharma with SUSMED. While digitalization will furthermore drive acceleration of process efficiency, we will continue to pursue further improvement of quality and efficiency of clinical trials in monitoring work by utilizing CMIC's know-how based on numerous clinical trial experiences over the past 30 years." About Aculys Pharma, Inc. Aculys Pharma is a biopharmaceutical company focused on the development and commercialization of innovations in the fields of neurology and psychiatry. Its corporate name was created from the philosophy of "Catalyst to Access." Aimed to act as a bridge for innovative medical care in the field of neuropsychiatry, Aculys Pharma develops and commercializes novel pharmaceuticals and provides innovations for better medical care to patients, their families, healthcare professionals, and society.

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Love Pharmas Investment in US Biotech Offers Strategic Industry Advantages and Enhanced Shareholder Value

LOVE Pharma | September 09, 2022

Love Pharma Inc. an international mental health and sexual wellness company, remains extremely active in shaping itself into a real competitor in the biotech/pharmaceutical space. The company’s growth and development plan took a major leap forward this week with the announcement that Love Pharma is establishing a “strategic alliance” with Starton Therapeutics a leading clinical-stage biotechnology company in the United States. It’s a relationship that finds Starton ideally aligned with Love Pharma’s mission of improving “quality of life” for its customers. And the benefit to Love Pharma is that Starton is well on its way to transforming standard of care therapies with its proprietary dermal drug delivery technology that allows cancer patients to receive continuous treatment so they can live better, longer. Love Pharma’s investment in Starton Therapeutics is primarily based upon “the company’s interest in innovative drug delivery technology, such as transdermal patches that can reduce side effects, transforming patient outcomes with established, approved medicines allowing for streamlined market entry with long-term IP protections.” A partnership with Starton offers a host of advantages to Love Pharma and its shareholders, including a wealth of experience from industry leaders, proven clinical trials using its proprietary technology, and a “continuous drug delivery” platform that Love Pharma could exploit in the development of its own clinical portfolio—especially in the “addiction” space. The company’s strategic investment certainly makes a lot of sense for the future of this young global brand. “This investment provides our shareholders with exposure to a rapidly developing therapeutics business, which just reported positive data from a phase 1 clinical trial evaluating the pharmacokinetics and safety of the company’s continuous delivery lenalidomide program. Starton is also entering a phase 2 trial, which the U.S. Food and Drug Administration has already cleared an Investigational New Drug application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV). Love Pharma’s Chief Executive Officer (CEO), Zachary Stadnyk, said of the relationship “With this investment in Starton, we are building our relationship, forming an alliance, and look to Starton’s expert management team to reduce risk in our own portfolio of clinical pursuits and focus more on the addiction space.” So, what made Starton Therapeutics an attractive investment now? Well, earlier this year, Love Pharma partnered with researchers at Johns Hopkins University. This research initiative aligns with key principles in Love Pharma’s strategy as it aims to develop innovative products that establish new consumer applications based upon science and efficacy. And to further its meticulous plan, the company likely sees a much smoother path forward by expanding its development strategy to include guidance from a vast selection of industry and clinical experts and a highly de-risked avenue into the clinic by way of this strategic alliance with Starton. It's no secret that Love Pharma wants to develop its own clinical portfolio, and specifically, has its eye on developing therapeutic treatments for addiction. Pharmaceutical applications for addiction and recovery treatment are an unmet need and represent a growing market, including in the cannabis space where the Johns Hopkins research initiative is focused. With Starton’s mission of delivering meaningful patient outcomes by leveraging the untapped potential of continuous delivery and dermal technology, it’s obvious that Love Pharma sees this platform technology and its endless opportunities for expansion, as an ideal platform on which it can develop its own therapeutic treatment(s) for addiction. The benefit to partnering with Starton and having access to its platform technology is that the “proof of concept” is complete, and the technology has proven it can address unmet medical needs using already FDA-approved drugs to transform patient outcomes. For Love Pharma and its shareholders, this means much of the hard work is already done. Starton’s proprietary continuous delivery technology can increase efficacy of approved drugs, make them more tolerable, and expand their potential use. Starton uses three different delivery technologies to provide continuous, low-dose delivery as part of its strategic platform that provides a controlled, sustained release over multiple days. Starton uses proven transdermal and subcutaneous technologies to transform approved medicines–establishing superiority or new indications. It is the potential to establish a new indication/use for already approved drugs using the delivery technology, namely in the addiction space that is enticing to Love Pharma. And Love Pharma isn’t stopping there. The company announced that “to further accelerate its planned strategic alliance with Starton, and to bolster the company’s own biotech initiatives in the area, Love Pharma is in discussions with TRPL Laboratory, the lab that develops and supports Starton’s transdermal drug delivery programs and is a global leader in transdermal delivery systems.” Investors in Love Pharma couldn’t ask for a better way to reduce the risk associated with the company developing its own clinical portfolio than by surrounding itself with a plethora of industry and clinical leaders. That expertise begins with Pedro Lichtinger, the CEO and Chairman of the Board at Starton. Lichtinger has spent almost 40-years in the biotechnology arena, including 16 years at Pfizer as President of Global Primary Care and as Pfizer’s President of Europe. Additionally, Love Pharma can draw from the experiences of the former Global Lead, Multiple Myeloma at Celgene, world-renowned scientific leaders in their field leading each program at Dana Farber/Harvard, Mayo Clinic, and Moffitt Cancer Center, and a breadth of operational expertise in regulatory, clinical development, manufacturing, and intellectual property. The company stated that it is currently identifying and assessing disruptive opportunities within the transdermal biotechnology field, which it believes can be a superior delivery system in many cases for new and existing pharmaceutical therapeutic drugs. With its initial investment in Starton, the company believes it can leverage their expertise and proven success to credibly evaluate potential acquisitions in the transdermal field of advanced drug delivery systems. This news should be seen as extremely encouraging by the company’s investors as it could dramatically accelerate Love Pharma’s path to the clinic and the development of its own clinical portfolio. After all, it is these relationships in the biopharma industry that can lead to promising results and real shareholder value. About Love Pharma Inc. With a focus on the global sexual Health and Wellness markets, Love Pharma Inc. was founded in 2020, with a mission to bring to market innovative products that enhance sexual health and wellness while providing an improved quality of life. Love Pharma holds exclusive licenses to produce, market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the United Kingdom, and North America. About Starton Therapeutics A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary dermal technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use. About Stock Market Media Group Stock Market Media Group is a News and Media content development IR firm offering a platform for corporate stories to unfold in the media with press releases, feature news articles, research reports, corporate videos, and radio-style CEO interviews.

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With headquarters in France, Sanofi is one of the largest pharmaceutical companies in the world. A global leader in healthcare, Sanofi is committed to preventing and treating diseases and supporting people around the world.

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