Astellas, CytomX form T-cell engaging cancer antibodies partnership

PharmaTimes | March 26, 2020

Astellas has entered into a new partnership with CytomX Therapeutics, in order to develop T-cell engaging bispecific antibodies targeting CD3 and tumour cell surface antigens for the treatment of cancer. The companies have revealed that the deal, which is potentially worth more than $1.6 billion, will focus on several initial programmes, with CytomX leading research and discovery activities, up to clinical candidate selection, which will be funded by Astellas. As part of the deal, Astellas has confirmed that it will make an upfront cash payment of $80 million to CytomX, with the latter eligible to receive future milestones of over $1.6 billion

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Every product that goes out the door should work as intended, every time.Tom McLean, VP Development Engineering says that the Scottsdale, AZ, crew accepts this challenge and takes it very seriously. In the second installment of our video tour of the plant, Scottsdale colleagues discuss how they work together to achieve these important goals while manufacturing products


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BUSINESS INSIGHTS

Daewoong Pharmaceutical and HanAll Biopharma Invest in Turn Biotechnologies to Expand Growth Initiative

Daewoong Pharmaceutical and HanAll Biopharma | April 12, 2022

Daewoong Pharmaceutical and HanAll Biopharma announced expansion of their open collaboration strategy by investing in Turn Biotechnologies, a Silicon Valley based company focused on developing novel mRNA medicines. The companies are supporting Turn Bio's continued development of a high-potential platform and are considering future long-term collaborations. Turn Bio is a pre-clinical-stage biopharmaceutical company focused on cellular repair via epigenetic reprogramming of cells. The technological foundation for Turn Bio's proprietary Epigenetic Reprogramming of Age (ERA™) methodology was developed by Turn Bio's co-founders in the Sebastiano Lab, Institute for Stem Cell Biology and Regenerative Medicine, Stanford School of Medicine. The technology has since been patented and Turn Bio is currently using it to complete pre-clinical research on therapies targeting indications in dermatology and immunology, as well as developing therapies for ophthalmology, osteoarthritis and the muscular system. "Many age-related diseases have long been significant areas of patients' unmet need. Turn Bio's innovative platform may bring a pivotal transformation to a wide array of therapeutic areas. HanAll is committing support and investment to help realize the full potential of this pioneering technology as Turn Bio advances to a new phase of growth." Dr. Almira Chabi, chief medical officer and chief development officer at HanAll Pharmaceutical International "The support of Daewoong Pharmaceutical and HanAll Biopharma validates our approach to cellular rejuvenation and enables Turn to expand its efforts in multiple therapeutic indications," said Anja Krammer, the company's CEO. "We are thrilled that a company as well known for its innovation, has taken interest in our promise to transform the way medicine treats diseases of aging and we look forward to further collaborations to help change quality of life and healthcare economics globally." The proceeds from this round of financing will support Turn Bio's advancement towards a phase 1 trial of its mRNA therapy candidate TRN-001, which targets indications in dermatology. About HanAll Biopharma Co., Ltd. HanAll Biopharma is a global biopharmaceutical company founded in 1973, with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful therapies to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas ranging from endocrine, circulatory, and urologic diseases for more than 48 years. HanAll has also expanded its focus to ophthalmology, immunology, oncology and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. A leading pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody drug, is in Phase 3 and Phase 2 trials across the world for the treatment of rare autoimmune disorders including myasthenia gravis, thyroid eye disease, warm autoimmune hymolytic anemia, neuromyelitis optica, and immune thrombocytopenia. Another main asset, HL036 (INN: tanfanercept), an anti-TNF alpha protein drug, is in Phase 3 clinical trials in the US and China for the treatment of dry eye disease. About Daewoong Pharmaceutical. Co., Ltd. Established in 1945, Daewoong Pharmaceutical Co., Ltd. is a leading South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both domestic and international markets. With a strong and innovative in-house R&D and advanced manufacturing facilities, Daewoong provides a total healthcare solution to customers across the globe. Continuing on its course of building a strong global healthcare company, Daewoong has broadened international operations by establishing branch offices and research centers throughout Asia and the United States. Daewoong has also expanded strategic partnerships in more than 100 countries worldwide. About Turn Biotechnologies Turn Bio is a pre-clinical-stage company focused on repairing tissue at the cellular level. The company's proprietary mRNA platform technology, ERA™, restores optimal gene expression by combatting the effects of aging in the epigenome. This restores the cells' ability to prevent or treat disease, and heal or regenerate tissue and will help to fight incurable chronic diseases.

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PHARMA TECH

ILC Dover Announces North America Expansion to Meet Growing Demand

ILC Dover | March 11, 2022

ILC Dover LP specializing in innovative single-use and chemical workflow solutions for biotherapeutics and pharmaceutical processing, announced plans to significantly expand production capabilities in its Juarez, Mexico facility. This expansion is in response to the Company’s unprecedented growth in its life sciences business and entry into sterile liquid handling and chemicals content market. This investment will generate additional production capacity for its single-use powder storage, single-use fluid storage, and fluid transfer solutions and is scheduled to come online later this year. It also dovetails with recent acquisitions of critical sterile liquid production to provide broader workflow solutions for the Company’s growing customer base. The expansion in Juarez will complement the current global manufacturing footprint in Frederica DE, Durham NC, Stockport UK, Rossens Switzerland, and Blarney Ireland for its pharma and biotherapeutics customers. “Expansion in Juarez is an investment in our customers’ success and the next step in ILC Dover’s global growth journey. It strengthens our partnership with key pharmaceutical and biotherapeutics customers around the world — solidifying our ability to expand our presence in critical products for life-saving therapies, improve lead times, and securing our customers’ supply chain in North America. Most importantly, this expansion strengthens our position as a valuable and vertically integrated partner for our life science customers — supporting customers to continue to improve and optimize their workflows.” Corey Walker, CEO of ILC Dover Operational in Mexico since 2013, the addition of 20,000 sq ft of new Class 6 and 7 clean room space will support multi-site production of solutions for the biotherapeutic, cell & gene therapy, and pharmaceutical markets. ILC Dover’s Juarez site will use the same processes, raw materials, and equipment as other sites in the global network to provide redundant supply and reduced lead times for customers — consistent with the Company’s global quality system. This most recent expansion showcases ILC Dover’s commitment to growing its life science solutions for its global customer base. The Company acquired two strategic businesses this past year to accelerate its trajectory in critical life science applications: sterile solutions manufacturer KSE Scientific and medical contract design and manufacturing company Flexan. The proven capabilities and synergies offered with the addition of both companies enable ILC Dover to link single-use solutions and chemical solutions across its customers’ workflows. About ILC Dover ILC Dover is a world-leader in the innovative design and production of solutions for biopharmaceutical, pharmaceutical, medical device markets as well as a leading supplier for the (aero)space industries. Our customers will attest to our relentless dedication to high value products, advanced technology, and responsive service, as our visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947. About New Mountain Capital New Mountain Capital is a New York-based investment firm that emphasizes business building and growth, rather than debt, as it pursues long-term capital appreciation. The firm currently manages private equity, public equity, and credit funds with over $35 billion in assets under management. New Mountain seeks out what it believes to be the highest quality growth leaders in carefully selected industry sectors and then works intensively with management to build the value of these companies.

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BUSINESS INSIGHTS

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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PHARMACY MARKET

MediPharm Labs Enters United States Pharmaceutical Market with Submission of FDA DMF

MediPharm Labs Corp. | February 24, 2022

MediPharm Labs Corp. a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has completed a US FDA DMF for pure natural CBD API. The DMF will enable MediPharm to supply approved API to pharmaceutical companies currently conducting late-stage research. The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025, and there are over 20 strong novel cannabinoid-based drugs currently in the late-stage research process. These projects will all require pharmaceutical approved API if commercialized. MediPharm has already shipped good manufacturing practice ("GMP") CBD for development purposes to multiple established pharmaceutical companies. "The filing of a US DMF further advances MediPharm toward its ultimate objective of becoming a dominant supplier of API to pharmaceutical companies. This is a high value, high margin opportunity, and with the only purpose-built facility in North America to receive a domestic GMP licence specifically for the extraction of natural cannabinoids, MediPharm is positioned to capture share in this growing market. In the short to medium term, the DMF unlocks new sales channels and will enable us to further leverage the investments made to date on our high-quality pharmaceutical manufacturing platform. Over the longer-term, it ensures the Company is positioned as the go-to cannabinoid partner for pharmaceutical companies around the world." Bryan Howcroft, CEO, MediPharm About MediPharm Labs Founded in 2015, MediPharm specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, API and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets.

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Spotlight

Every product that goes out the door should work as intended, every time.Tom McLean, VP Development Engineering says that the Scottsdale, AZ, crew accepts this challenge and takes it very seriously. In the second installment of our video tour of the plant, Scottsdale colleagues discuss how they work together to achieve these important goals while manufacturing products

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