North America trade pact deals rare setback to Big Pharma

ABC News | December 20, 2019

A revamped North American trade deal nearing passage in Congress gives both the White House and Democrats a chance to claim victory and offers farmers and businesses clearer rules governing the vast flow of goods among the United States, Canada and Mexico. But the pact leaves at least one surprising loser: the pharmaceutical industry, a near-invincible lobbying powerhouse in Washington. To satisfy House Democrats, the Trump administration removed a provision that would have given the makers of ultra-expensive biologic drugs 10 years of protection from less expensive knockoffs. Democrats opposed what they called a giveaway to the industry that could have locked in inflated prices by stifling competition. Top examples of the injected drugs made from living cells include medications to fight cancer and immune disorders such as rheumatoid arthritis.

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IAMA Therapeutics Partners with the Italian Institute of Technology to Embark on Landmark Research on Neuroscience Drug Discovery

IAMA Therapeutics | March 31, 2022

IAMA Therapeutics, a Series 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, today announced a strategic collaboration with the IIT-Istituto Italiano di Tecnologia where they will design and profile new classes of compounds targeting cation cotransporters in the CNS area. This partnership consolidates a scientific collaboration between IAMA Therapeutics and IIT, which signed, together with the Telethon Foundation earlier in 2021, a license agreement, granting IAMA therapeutics an exclusive, worldwide license to research, develop, manufacture, and commercialize a novel class of modulators of intracellular chloride concentration. "We are pleased with and excited by this partnering opportunity with IAMA Therapeutics, a clear example of IIT technology transfer approach. We are setting the Italian way of producing science and tech-based innovation, where the collaboration among brilliant researchers, important founding agencies like Fondazione Telethon, and investors creates the right ecosystem enabling new businesses to emerge." Dr. Matteo Bonfanti, Director of Technology Transfer at Istituto Italiano di Tecnologia "We are very happy for the partnership between IAMA Therapeutics and IIT," said Francesca Pasinelli, General Manager of Fondazione Telethon. "This collaboration is based on innovative science, which was selected and nurtured earlier on by Fondazione Telethon. As part of our focus on fostering development, we funded the project and supported researchers through the technology transfer process together with IIT. Now, this promising research avenue is accessing the resources and competencies necessary to take and accelerate the long and expensive path to patients. It shows what can be accomplished through a timely and coordinated effort to maximize research impact". About IAMA Therapeutics IAMA Therapeutics is a pharmaceutical company that couples emerging advances in drug discovery and neurobiology to build a leading, next-generation neuroscience pipeline. We have developed a platform to identify and advance diverse classes of small molecules to selectively inhibit the sodium potassium chloride cotransporter and other therapeutic targets relevant to treating central nervous system disorders characterized by neuronal imbalance, including primary and secondary autism, epilepsy, and movement disorders. About Istituto Italiano di Tecnologia Istituto Italiano di Tecnologia is a foundation established jointly by the Italian Ministry of Education, Universities, Research, and the Ministry of Economic and Finance to promote excellence in basic and applied research and contribute to Italy's economic development. The primary goals of the IIT are the creation and dissemination of scientific knowledge and the strengthening of Italy's technological competitiveness. To achieve these two goals, the IIT cooperates with academic institutions and private organizations, fostering scientific development, technological advances, and training in high technology. About Fondazione Telethon Fondazione Telethon is a major biomedical charity in Italy whose mission is to advance biomedical research to cure rare genetic diseases. Throughout its 32 years of activity, Fondazione Telethon has invested almost €600 million in funding over 2,700 projects to study 580 diseases, involving more than 1,600 researchers in Italy. As part of its goal to foster development and maximize the therapeutic impact of research, Fondazione Telethon further pursues cooperation with academia, industry, and venture capital through the creation of partnerships and start-ups.

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BUSINESS INSIGHTS

AIkido Pharma Announces Strategic Investment in Social Communications Platform Provider Discord, Inc

AIkido Pharma Inc. | May 05, 2022

AIkido Pharma Inc. announced that the Company has secured an early equity interest in privately-held Discord, Inc. a social communications platform provider that is particularly popular with gamers. Bloomberg Technology reported on March 14, 2022, that Discord "is interviewing bankers about going public as soon as this year." According to the Bloomberg report, "Discord, last valued by private investors at about $15 billion, is especially popular with gamers and young people. Its success caught the attention of potential suitors, including Microsoft Corp., which was rebuffed after offering $12 billion for it last year." According to The Straits Times, Discord has also held discussions with Epic Games and Amazon.com in the past. "This investment fits well into our strategy to maximize opportunity for liquidity and monetization events for our shareholders. We believe the offer by Microsoft to buy the company bodes well for this investment, as does a potential near-term IPO." Anthony Hayes, CEO of AIkido About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV MERS-CoV, Ebolavirus and Marburg virus.

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BUSINESS INSIGHTS

AbCellera and Empirico Expand Strategic Multi-Target Antibody Discovery Collaboration

AbCellera | May 04, 2022

AbCellera and Empirico Inc. announced today that they have expanded their strategic multi-target discovery collaboration, which leverages Empirico’s Precision Insights PlatformTM to discover genetically validated drug targets and AbCellera’s technology to identify lead candidate antibodies against those targets. Following the rapid progress of their first collaborative program, which identified a lead candidate against an undisclosed G protein-coupled receptor target in less than 12 months, the companies have expanded their partnership to include seven targets. In addition, under the expanded agreement, AbCellera has a co-development option on a program-by-program basis. Empirico’s platform is designed to uncover causal relationships between genes, proteins, and clinical outcomes by integrating genetic data and health information from millions of individuals together with experimental validation. AbCellera integrates leading technologies to solve all steps in the antibody discovery process and delivers to partners diverse and developable lead candidates against drug targets. “We have been impressed by Empirico’s ability to discover and validate new drug targets and believe the combination of our respective technologies has great potential to bring new first-in-class treatments to patients. We are pleased to build on our productive collaboration with Empirico by expanding the number of targets and maximizing the opportunity for mutual success by having an option to co-invest on a program-by-program basis.” Carl Hansen, Ph.D., CEO and President of AbCellera “AbCellera’s technology enables us to extend our competitive advantage in target discovery and validation with best-in-class antibodies to rapidly advance our programs towards the clinic,” said Omri Gottesman, M.D., CEO and President of Empirico. “We are excited to expand our relationship with AbCellera and to translate many more genetically validated targets into potential new antibody-based therapies together.” Under the terms of the expanded agreement, Empirico will have the right to develop and commercialize therapeutic antibodies resulting from the collaboration, and AbCellera has the option to co-develop each therapeutic program to maintain up to a 50 percent ownership stake. Financial terms were not disclosed. About Empirico Inc. Empirico is a next-generation therapeutics company founded on utilizing human genetics, data science, and programmable biology to power novel target discovery and development. Empirico’s Precision Insights PlatformTM, a proprietary human genetics-focused discovery platform, leverages a world-leading dataset, hyperscale infrastructure and algorithmic approaches that encode and enhance human intuition to identify and prioritize therapeutic targets. All potential therapeutic targets are subjected to rigorous in vitro and in vivo experimental validation to elucidate the mechanism by which genetic variation impacts disease risk and provide insights about which therapeutic modality could be ‘programmed’ to mimic or interfere with that mechanism. Empirico is advancing multiple programs across a broad range of indications and therapeutic modalities, both independently and in collaboration with industry partners. Empirico is headquartered in San Diego, California with laboratories in Madison, Wisconsin. About AbCellera Biologics Inc. AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.

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BUSINESS INSIGHTS

LexisNexis® Reed Tech™ and Schlafender Hase® Alliance Provides Mutual Customer Benefits for Pharmaceutical and Medical Device Companies

LexisNexis Reed Tech | April 27, 2022

Reed Technology and Information Services Inc. a leading provider of data management and analytics solutions for the life sciences industry, announced an alliance with Schlafender Hase®, the market leader for intelligent, automated proofreading software and services for regulated industries. Current and prospective customers of both companies can leverage exclusive benefits as part of this new alliance ecosystem. Pharmaceutical labelers who have regulatory deadlines for US FDA can benefit from the expert conversion and submission services offered by Reed Tech while ensuring reduced risk and greater accuracy in the proofreading process for drug labels and related documentation with Schlafender Hase's TVT®, the Text Verification Tool®. "Schlafender Hase is already a trusted ally as part of our pharmaceutical SPL conversion process. By offering our UDI and pharma customers the benefits of TVT, we continue advancing our mission of providing innovation for the unique workflows of these specialty manufacturers. Ensuring the accuracy of labels, barcodes, graphics and IFU language is essential. With TVT®, regulatory team members around the world benefit from superior, automated proofreading in order to reduce risk and meet the compliance requirements of local health authorities," Arshad Rahman, General Manager of the Reed Tech Life Sciences division "Schlafender Hase is pleased to recognize Reed Tech as an industry-leading, core SPL conversion service provider. It will be productive for our customers to have access to their deep understanding of regulatory submission requirements for drug manufacturers and distributors," said Peter Muller, Sales Director, North America at Schlafender Hase. Those manufacturers bringing new products to market or maintaining existing portfolios will benefit from the subject-matter expertise offered by Reed Tech." Both the pharmaceutical and medical device industries are continually upgrading processes and preparing for multiple global health authority requirements. The complementary solutions and services between Reed Tech and Schlafender Hase offer critical efficiency gains in managing the product life cycle. About LexisNexis Legal & Professional LexisNexis® Legal & Professional provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 10,500 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. Reed Tech serves manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles by delivering better outcomes for the collection, transformation, submission and analysis of regulatory data. Our solutions support the innovation ecosystem and enable you to achieve regulatory compliance and improved product data management contributing to impactful innovations to our world. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis® company. About Schlafender Hase Schlafender Hase leads the way in intelligent, automated text and graphic proofreading solutions. With its flagship product, TVT®, the Text Verification Tool®, users can quickly compare source content with output formats, detecting changes and deviations prior to publication. Schlafender Hase serves regulated industries across the globe. Clients include the world's leading pharmaceutical and medical device companies, as well as healthcare regulatory bodies. The continued success of Schlafender Hase is based on delivering quality products and a strong understanding of customer pain points. Easy to use, our products reduce proofreading workloads, assure the quality of printed and online materials, and mitigate the risk of costly errors.

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Discover what strategies healthcare organizations are undertaking to address the top issues that face them: addressing cost pressures resulting from declining reimbursements and improving the patient experience. Learn about the steps necessary to address these issues and become an intelligent enterprise.

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