EMA’s PRAC to review Xeljanz and recommends fenspiride withdrawl

pharmatimes | May 20, 2019

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has announced its latest meeting highlights, including a restriction of the use of Xeljanz (tofacitinib), and a call for withdrawal of marketing authorisations for fenspiride medicines. The Xeljanz restriction comes as the organisation has started a new review of the drug, and has recommended, as a temporary measure during the review, that doctors must not prescribe the 10 mg twice-daily dose of this medicine in patients who are at high risk of blood clots in the lungs. The Pfizer oral JAK inhibitor is currently authorised for the treatment of rheumatoid arthritis, psoriatic arthritis and severe ulcerative colitis. The PRAC stated that these include patients who have heart failure, cancer, inherited blood clotting disorders or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement therapy or are undergoing major surgery.

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Adalvo Partners With SK Pharma to Create Arphio, a New Business Entity Dedicated Solely to Orphan and Rare Disease Medicines

Adalvo | March 01, 2022

Adalvo, the leading global B2B pharmaceutical company, is thrilled to announce the recent establishment of a new entity ArphioTM a venture initiated in close collaboration with SK Pharma. Together with our new partner, we are developing a powerhouse, solely dedicated to orphan drugs with the intention of improving accessibility of vital treatments, to patients suffering from rare diseases and unmet medical needs. ArphioTM will operate as an independent entity, focusing on rare disease detection, market access and supply of orphan drugs, targeting the EU and ROW regions. ArphioTM has a unique understanding on orphan products and their epidemiology data and unique characteristics. The aim of this venture is to expand access to vital treatments and continue to develop technological capabilities and expertise, while maintaining a patient-centric approach with the possibility of relying on state-of-the art novel technology including worldwide data, artificial intelligence, and machine learning. Arphio is founded by pharmaceutical professionals with expertise covering all major therapeutic areas and pharmaceutical forms in various parts of the globe. The company is focused on rare disease detection, market access and the supply of orphan drugs internationally. Arphio is powered by DrugsIntel (DI), a data science powerhouse focusing on the aggregation, unleashing, processing, unification and deployment of pharmaceutical data covering over 75 countries, and over 6,000 sources. This intelligence tools ensure the successful launch of orphan drugs in the market of operation, based on DI’s unique methodology of these Six factors and Pillars. This stand-alone market player will cover all services and functions ranging from medical, market access, regulatory, direct sales, and marketing activities. ArphioTM proudly boasts of strictly following ethics, compliance, accessibility, and corporate governance. There are over 300 million people living with one or more of over 7,000 identified rare diseases around the world, each supported by family, friends, and caregivers. Currently, only about 5% of orphan disorders can be managed with an approved treatment. It is estimated that it takes about seven years and visits to 10 different doctors for a patient to receive a proper diagnostic of an orphan condition. At ArphioTM, fueled by our passion to improve people’s lives, we will apply innovative technologies to provide effective treatments for people with orphan diseases. Anil Okay, General Manager at Adalvo comments: “We are thrilled to be partnering with SK Pharma on this exciting new journey. We welcome this opportunity to work in the domain of Orphan drugs, and we are eager to make a valuable contribution to patients across the globe who are living with Rare diseases”. “I’m captivated to have Adalvo as our partner with the important endeavor of helping neglected orphan patients and their caregivers with their unmet medical needs. I’m bullish on the synergistical power that could outcome from this collaboration for the benefit of rare disease patients". Dr. Shlomo Sadoun, CEO at SK Pharma About Adalvo Adalvo is a global pharmaceutical company, and one of the leading B2B pharmaceutical companies in Europe, with commercial partnerships in more than 70 countries and for over 90 commercial partners globally. The company’s declared purpose is to make a difference for patients all over the world, driven by our smart collaboration network and commitment to delivering highest quality differentiated products and services to our partners. With headquarters in Malta, the company has additional offices in more than 15 countries such as Switzerland, UK, Netherlands, Spain, Iceland, Austria, Romania, Hungary, Bulgaria, Portugal, Czech Republic, and India. At Adalvo, we know that our partners like to be bigger, better, and smarter in the dynamic pharmaceutical sector. That’s why our approach is unique, customized to our partners, and is designed to challenge the status quo: together, this helps our partners achieve their business goals. We take pride in our ability to help its partners reach their goals – be those increasing revenues or pushing into new markets. While partners are a high priority, Adalvo is also committed to its purpose and mission to accelerate the growth and development of employees and local communities. Adalvo tirelessly strives for excellence in all of its endeavors, driven by a deep-rooted passion to making a difference for partners. The company’s purpose driven culture is committed to improving the lives of patients around the world. Our dynamic leadership team brings significant experience and industry know-how to Adalvo, which has helped to establish the company as a reliable global partner. About SK Pharma SK-Pharma is a global pharmaceutical company focusing on making drugs accessible to patients in needs. The vison of the company lay in utilizing cutting edge technologies to support smart business decisions that will lead to better healthcare solutions. Taking patient centric approach, the company holistically follow the patient’s journey and understand better their unmet needs. Mimicking the patient journey allow us to come with viable solutions that change the patient treatment paradigm and make it more suitable to their lifestyle and their unique needs. The group is divided to three divisions: First to launch and the introduction of complex hybrid generic products. The second division is focusing on providing technological solutions to enhance smart business decisions. The third division is specialized in orphan drugs market access and distribution worldwide.

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Ultivue Announces Co-Marketing Agreement with Aignostics for Unique Spatial AI-Powered Imaging Solutions for Translational Medicine

Ultivue, Inc., | March 10, 2022

Ultivue, Inc., an industry leader in multiplexing tools and novel image analysis solutions for tissue biomarker studies, and Aignostics GmbH, a global leader in Artificial Intelligence (AI) powered precision diagnostics focused on pathology to assist with research, clinical trials and CDx development, announced a partnership to collaborate on the co-development of AI-powered spatial multiplexed immunophenotype solutions for translational research groups and Biopharma. The companies have already been working together since early 2021 to adapt Aignostics’ client platform to support visualization and analysis for some of Ultivue’s products and services, as well as provisioning of results and corresponding reports. The resulting co-developed platform will now be made available to joint clients. Additionally, proof of concept work conducted on the Ultivue 12-plex Immunophenotyping biomarker panel in over 1,000 clinical NSCLC cases has demonstrated encouraging results for the capacity of AI-based analysis of multiplexed images for more consistent and reproducible readouts at scale. These results will be published later this year and respective AI models made available via the platform. The companies are now expanding their relationship under a co-marketing agreement to offer the multiplex immunofluorescence (mIF) platform to their respective biotech and pharma clients, initially for research use, with a GCP-compliant version to follow later this year. Moreover, Ultivue and Aignostics will offer AI-powered image analysis services within the platform via Aignostics “Explainable AI” approach for the consistent and precise analysis of mIF cohorts at scale, for both translational research and clinical trial research services in Ultivue’s CLIA accredited clinical research laboratory. “We are excited to extend our workflow offering to include mIF AI for highly automated image analysis by partnering with Aignostics,” says Florian Leiss, VP Digital Health at Ultivue. “Improved viewing capabilities enable us to interactively explore the interplay of mIF-labeled cell populations in the histological context of same-slide H&E.” “We believe that development of Ultivue’s assays with our AI-powered image analysis will create insights from data at scale that are unprecedented in spatial biology today. We are excited to start offering this approach to our clients for translational science and clinical trials,” Viktor Matyas, CEO of Aignostics Besides offering research and development services to its clients, Ultivue and Aignostics will also develop products for standardized analysis of certain Ultivue products, paving the way for more widespread use of these technologies in both clinical trials and clinical routine. About Ultivue Ultivue provides researchers and scientists in translational medicine with multiplex biomarker assays for tissue phenotyping and digital pathology. Its proprietary InSituPlex® technology enables advanced exploration and interrogation of tissue samples for precision medicine research. These highly customizable solutions coupled with our scientific consultative approach strengthen and accelerate biomarker discovery and drug development programs. About Aignostics Aignostics, a Berlin based company with offices in the US, is a digital pathology company dedicated to novel precision diagnostics through the use of a proprietary “Explainable AI” platform in pre-clinical and translational research and clinical trials. The use of such technology is expected to be crucial to implementation of AI-powered algorithms in routine diagnostics in order to verify (explain) the model’s decision outputs. Additionally, through its close alignment to Charité and TU Berlin amongst other collaborators, only Aignostics offers the combination of data access, sample testing and pathology expertise to develop digital pathology algorithms spanning multi-modal biomarker assay detection systems such as H&E, IHC and mIF, amongst others.

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BUSINESS INSIGHTS

Jazz Pharmaceuticals Announces Agreement to Divest Sunosi® (solriamfetol) to Axsome Therapeutics

Jazz Pharmaceuticals plc | March 28, 2022

Jazz Pharmaceuticals plc announced that it has entered into a definitive agreement to divest Sunosi® a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea to Axsome Therapeutics. Under the terms of the agreement, Axsome will receive the rights to Sunosi in all of the existing territories available to Jazz. Jazz will receive attractive financial terms including an upfront payment of $53 million, a high single-digit royalty on Axsome's U.S. net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome's U.S. net sales of Sunosi in future indications. The divestiture of Sunosi to Axsome will enable Jazz to sharpen its focus on its highest strategic priorities designed to deliver sustainable growth and enhanced shareholder value. In assessing the positioning of Sunosi in the overall treatment landscape, Jazz determined Axsome would be well positioned to deliver access to this important medication and to maximize the value of Sunosi to Jazz through future growth. Sunosi's consistent positive feedback from patients, HCPs and providers is underscored by its well-established and clinically meaningful efficacy. Importantly, Jazz and Axsome are committed to ensuring that patients receive uninterrupted access to Sunosi throughout the transition. Wake-promoting agents are most often prescribed by psychiatrists, neurologists and general practitioners. Therefore, Jazz believes Axsome is well placed to leverage its commercial business, which will have highly complementary call points, to drive Sunosi as one of the lead products in their portfolio and ensure Sunosi can continue to reach those patients who may benefit from this important medicine. "This transaction advances our efforts to deliver sustainable growth, enhanced shareholder value and drive the transformation of Jazz to an innovative, global biopharmaceutical leader. Jazz will continue to be laser-focused on investing in our highest strategic priorities including our ongoing launches, advancing our pipeline, pursuing opportunistic corporate development and achieving margin expansion. Through our development and launch of Sunosi, the Jazz team has laid the foundation for Axsome to continue supporting people who may benefit from this much-needed treatment. As a leader in sleep medicine and rare epilepsies, with a growing oncology franchise, Jazz remains committed to developing new, innovative therapies in neuroscience and oncology for patients and delivering on our recently announced Vision 2025." Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals "We are impressed by the clinically meaningful efficacy, unique mechanism of action, positive patient and physician feedback and growth potential of Sunosi, and are excited by the excellent strategic fit with the Axsome portfolio. The addition of Sunosi will augment and accelerate our commercial preparedness ahead of the potential near-term launches of our two existing lead assets and allows us to fully leverage our first-in-class Digital Centric Commercialization™ platform with three complimentary assets," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. Sunosi is a dopamine and norepinephrine reuptake inhibitor indicated for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) in adult patients. Sunosi is the first DNRI approved to treat EDS in adults living with narcolepsy or OSA. About Sunosi® Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). Sunosi received U.S. Food and Drug Administration approval on March 20, 2019, to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the U.S. Drug Enforcement Agency on June 17, 2019. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States. About Jazz Pharmaceuticals Jazz Pharmaceuticals plc is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries.

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Bruker Acquires Optimal Companies for Pharma PAT Software and Biopharma Manufacturing Automation Expertise and Technologies

Bruker Corporation | April 06, 2022

Bruker Corporation announced the acquisition of Optimal Industrial Automation and Technologies, a leader in pharma and biopharma process analytical technology pharma manufacturing automation and Quality Assurance (QA) software and systems integration, based in the United Kingdom. The Optimal biopharma tools acquisition strengthens Bruker as a key software and solutions provider for small molecule, biologics and new drug modalities pharma companies. Financial details of the acquisition were not disclosed. Optimal’s 2022 revenue is expected to be approximately $10 million, and Optimal’s revenue growth rate and operating margins are projected to be accretive to Bruker in 2023 and beyond. The Optimal biopharma tools and automation capabilities complement Bruker’s innovative and differentiated high-value NMR, mass spectrometry, SPR, molecular spectroscopy and X-ray scientific instruments, and life-science solutions for biopharma drug discovery and development, as well as for PAT analytical and QA solutions. Together these biopharma tools enable Bruker’s global biopharma customers to bring efficacious and safe medicines to market more quickly. Optimal has a focus on the automation and optimization of batch and continuous processes in the biopharma industry – from R&D to manufacturing. As an integrated PAT solutions provider, Optimal offers development, testing, deployment and support of quality-centric pharmaceutical production systems. Optimal has more than 30 years of experience in successfully delivering regulatory-compliant biopharma solutions, ranging from the development of automated control systems for process control to the market-leading, vendor-agnostic PAT knowledge management software synTQ®. The synTQ PAT software can interface between multiple analytical instruments (spectral and univariate), multi-variate analysis (MVA) packages, manufacturing control systems and a range of adjacent software solutions to ensure quality in real-time. As a 2021 Pharma Innovation Award winner, synTQ is a proven enabler of quality-by-design (QbD) via PAT. For users of synTQ, this can significantly increase productivity and quality, while reducing waste, time-to-manufacture and time-to-market, with proven Optimal use cases tripling biopharma productivity. While remaining a vendor-agnostic biopharma solutions provider, Optimal can integrate bioanalytical technologies such as nuclear magnetic resonance (NMR), mass spectrometry (MS) and FTIR/NIR/Raman systems into innovative drug discovery, development, PAT and quality control workflows. Combining next-generation, high-performance technologies with Optimal solutions eases the transition from development to biopharma manufacturing, while remaining in regulatory compliance. “The acquisition of Optimal is a very exciting step for Bruker as it supports more comprehensive solutions for the biopharmaceutical industry, now adding the capabilities to integrate cutting-edge systems into biopharma manufacturing processes and workflows. We welcome the Optimal team with their strong PAT and automation expertise and, together, are eager to support biotech and pharmaceutical companies in increasing their manufacturing efficiency and flexibility – a global need highlighted by the response to the pandemic crisis.” Dr. Falko Busse, President of the Bruker BioSpin Group Mr. Martin Gadsby, the CEO and Co-Founder of Optimal Industrial Automation and Technologies, added: “We are delighted to become part of the Bruker family. Optimal and Bruker together are a perfect fit – we share the common ethos of innovation with integrity, together with our industry recognition as a high-quality solutions provider delivering tangible benefits to our customers. The whole Optimal team is excited by this new chapter in our history and looks forward to delivering benefits to even more biopharma customers and ultimately to patients around the world.” About Optimal Industrial Technologies and Automation A well-established system integrator with more than 30 years of experience, at Optimal we specialize in automating a client’s R&D or manufacturing system to ensure that their processes remain at the highest level of efficiency. The demands being placed on manufacturers in relation to production costs, product quality and business sustainability are ever increasing, and our primary aim within Optimal is to assist you in being the most competitive supplier of your product to the highest level of quality in the worldwide marketplace, and to ensure that you continue to maintain your lead in the years ahead. We have a rare and wide-ranging skill set covering a multitude of automation technologies, manufacturing processes and industry types, with very specific knowledge in highly regulated environments. In addition, we manufacture the world leading PAT Data Management software package - synTQ® and the widely used integrated Print and Inspect system - synTI®. The combination of our PAT implementation knowledge and synTQ® product together with our automation experience positions us with unique skills that can be leveraged to great advantage by our customers. About Bruker Corporation Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology.

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