Rinvoq bags FDA green light

PharmaTimes | August 19, 2019

AbbVie has announced the US Food and Drug Administration FDA approval of Rinvoq upadacitinib for moderate to severe active rheumatoid arthritis RA. In the SELECT programme, the oral JAK inhibitor met all primary and ranked secondary endpoints across a variety of patients with moderately to severely active rheumatoid arthritis, and significantly inhibited radiographic progression even without methotrexate. The study was one of the largest registrational Phase III programs in RA with approximately 4,400 patients evaluated across all treatment arms in five studies, which included assessments of efficacy, safety and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naive or inadequate responders to methotrexate. Rinvoq is not indicated for methotrexate-naive patients. "Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity—the primary treatment goals for rheumatoid arthritis," said Roy M. Fleischmann, primary investigator for SELECT.

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Gregory Willocq, years, news anchor and former editor of RTL Info, joined the communications team pharma.be, the umbrella organization of the innovative pharmaceutical industry in Belgium.


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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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Verizon Business Selected to Transform Astellas Pharma’s Global Network Infrastructure

Verizon Sourcing LLC | August 10, 2022

Verizon Business has been selected to manage Astellas Pharma Inc’s global network infrastructure. The network transformation will enable Astellas to harness advanced technologies to help reduce drug development timelines, healthcare costs and drive new revenue opportunities for the Japanese pharmaceutical multinational. Headquartered in Tokyo, Japan, Astellas is a global pharmaceutical company involved in the research, development, manufacture, and marketing of innovative new drugs under the vision of “Stand on the forefront of healthcare change to turn innovative science into VALUE for patients”. The company employs 14,000 employees worldwide. The company has identified digital transformation as a key driver of its business growth and began the search for a global partner to transform all aspects of its global technology infrastructure including building, designing and executing a next-generation secure network. In particular, Astellas was looking for a scalable and predictable platform that could seamlessly manage tens of thousands of devices and endpoints across Astellas’ 70+ global locations across a virtualized multi-sourced environment. Verizon’s relationship with Astellas stretches back more than a decade. In 2016, Astellas successfully deployed Verizon’s Secure Cloud Interconnect solution to provide a high-bandwidth secure connection to its Amazon Web Services and Microsoft Azure cloud services. Verizon’s current remit includes the build and deployment of Astellas’ global integrated network with a full suite of managed services, including Managed Wide Area Network, Local Area Network, Managed Security Services Secure Gateway, Zero Trust Network Access and Unified Communications and Collaboration as a Service. “From R&D to sales, we are seeing enormous amounts of data and intelligence flow through our business, across our 70 locations around the world. We want to ensure that we have a future-proof network in order to utilize cutting-edge technologies such as Artificial Intelligence, machine learning and robotics to make data-driven decisions to deliver better value for our patients. Our network transformation will underpin the next phase of our growth.” Shinya Suda, Senior Vice President, Information Systems, Astellas “The network is transformative in its ability to enable innovation and growth and Astellas is changing the way they are using the tools at their disposal to completely revolutionize their business. This is truly a watershed moment for the pharmaceutical industry as companies grapple with the pressures of reducing time and costs for the development of drugs while improving patient care and value. We’re proud to have been a part of Astellas’ growth journey for more than a decade,” said Robert Le Busque, Regional Vice-President, Verizon Business Group, Asia Pacific. Today’s announcement builds on the company’s network-as-a-service foundation and supports its private networks, mobile edge compute and business solutions vectors of growth. Verizon Communications Inc. was formed on June 30, 2000 and is one of the world’s leading providers of technology and communications services. Headquartered in New York City and with a presence around the world, Verizon generated revenues of $133.6 billion in 2021. The company offers data, video and voice services and solutions on its award-winning networks and platforms, delivering on customers’ demand for mobility, reliable network connectivity, security and control. VERIZON’S ONLINE MEDIA CENTER News releases, stories, media contacts and other resources are available at verizon.com/news. News releases are also available through an RSS feed.

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Glaukos Licenses Iveena’s Investigational Keratoconus Therapy

iVeena and Glaukos | August 25, 2022

iVeena Delivery Systems Inc. a clinical stage biopharmaceutical company with developmental products in keratoconus and pediatric myopia, has entered into a strategic licensing agreement with Glaukos Corporation that grants Glaukos an exclusive global license to develop and commercialize IVMED-80, a pharmacologic treatment for keratoconus. Keratoconus, a rare corneal disorder, is the leading cause of primary full-thickness corneal transplantation in the United States. IVMED-80 is a proprietary disease modifying topical eye drop with orphan drug designation that upregulates lysyl oxidase and induces pharmacologic corneal crosslinking to strengthen the cornea and treat keratoconus. In a 6-month phase 1/2a clinical study, IVMED-80 met its primary endpoint of a statistically significant reduction in baseline-adjusted Kmax of 1.0 D relative to placebo. “We are pleased to complete this agreement with Glaukos. This deal validates the technology we have developed at iVeena to induce corneal crosslinking pharmacologically via eyedrops. Glaukos is a strong partner to complete development of this product where, if approved, patients will have an additional keratoconus treatment option.” iVeena CEO Jerry Simmons As part of the agreement Glaukos paid $10 Million upfront and will assume all costs associated with development and regulatory activities on IVMED-80. In addition, deal terms include the potential for both development and sales milestone payments as well as royalties on sales to iVeena. About iVeena iVeena Delivery Systems, Inc. is a privately held, clinical stage ophthalmology company developing disease-modifying pharmacologic innovations for refractive diseases. iVeena has licensed its lead asset to Glaukos Corporation, IVMED-80, an Orphan Drug Designated eye drop for keratoconus. iVeena is developing IVMED-85, a first in class, investigational eyedrop formulation for pediatric myopia where it plans to initiate a first in human clinical trial early 2023. About Glaukos Glaukos is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and has since developed a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.

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Gregory Willocq, years, news anchor and former editor of RTL Info, joined the communications team pharma.be, the umbrella organization of the innovative pharmaceutical industry in Belgium.

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