Ground-breaking collaboration to offer new heart disease drug to NHS patients

Pharmacy Business | January 14, 2020

The government on Monday announced a collaboration with Novartis to launch a clinical trial for ‘yet to be approved’ drug inclisiran. The drug could benefit thousands of patients at risk of heart disease in coming years. The ground-breaking collaboration includes Novartis, NHS England and the National Institute for Health Research (NIHR) and Oxford University. The Department of Health and Social Care (DHSC) expects this to position the UK as a world-leading destination to develop cutting-edge treatments. Inclisiran, a treatment to lower cholesterol, will be studied in UK patients as part of the large-scale NHS clinical trial expected to start later this year. According to DHSC, early clinical trial results suggest that the drug could help prevent 55,000 heart attacks and strokes if it is given to 300,000 patients annually.

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PHARMACY MARKET, PHARMA TECH

MTTI Obtains FDA Allowance of Investigational New Drug (IND) for Hürthle Cell Thyroid Cancer

Molecular Targeting Technologies, Inc | December 09, 2022

Molecular Targeting Technologies, Inc. a clinical stage radiopharmaceutical therapy company focused on therapies for rare diseases, announced today the allowance of an Investigational New Drug application by the U.S. Food and Drug Administration. It is now waiting for Institutional Review Board approval. Once approved by IRB, it will enable a Phase I/II clinical study of the Safety, Dosimetry and Efficacy of EBTATE in adult patients with metastatic, radioactive iodine non-responsive Hürthle cell thyroid cancer.” EBTATE is a new generation of peptide receptor radiotherapeutic drug that has demonstrated potential clinical superiority over standard of care. It selectively binds to somatostatin receptor 2 on neuroendocrine and other tumors, which are then killed by the radionuclide. EvaThera platform products were designed to bind to serum albumin, due to the Evans blue moiety, extending in vivo residence time, enabling lower, less frequent dosing of the radiopharmaceutical and reducing risk of renal injury vs. the current standard of care. Dr. Joanna Klubo-Gwiezdzinska, MD, Ph.D, MHSc, acting section chief of Thyroid Tumors and Functional Thyroid Disorders in the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH) and study author commented: “Hürthle cell thyroid cancer, which currently lacks effective treatment options, is characterized by a particularly high expression of SSTR2*. With this phase I/II clinical trial, we hope to implement individualized dosimetry-based dosing for each patient with Hürthle cell thyroid cancer that spread outside of the thyroid gland and analyze how much of an active agent is being accumulated in the tumor tissue to establish a threshold associated with the best efficacy and safety.” “The clearance of our IND is an important milestone for MTTI. Having solidified our clinical trial preparedness and manufacturing readiness, we are well-positioned to advance EBTATE to target Hürthle cell thyroid cancer.” Dr. Chris Pak, President & CEO of MTTI About Molecular Targeting Technologies, Inc. (MTTI) Molecular Targeting Technologies, Inc., is a privately held, rapidly growing, well financed, clinical-stage biotech company developing next-generation targeted radiotherapeutics and diagnostics for rare cancers. Evathera platform technology product has shown application for glioblastoma multiforme (GBM) cancer patients overexpressing integrin. MTTI is committed to building value by acquiring and translating innovative imaging, radiopharmaceutical and theranostics assets to improve human health, reduce healthcare costs and reward stakeholders. MTTI expects to be orchestrating multiple clinical trials in 2023. The content in this release is the sole responsibility of the authors and does not necessarily represent the official views or imply endorsement of the National Institutes of Health.

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PHARMA TECH

Three iA Employees Honored with Top Women in Health Awards

iA | November 18, 2022

iA, a provider of software-enabled pharmacy fulfillment and automation solutions, celebrated three of its employees being recognized at Drug Store News’ Fourth Annual Top Women in Health, Wellness & Beauty Awards held in Chicago, Illinois. Rachael Clark, Vice President of Commercial Sales, received a Rising Star award. As Vice President of Commercial Sales, Rachael works with large-scale retail chain grocery stores, mainstream pharmacies, and digital pharmacies, as well as independent mom-and-pop operations. Rachael is responsible for a team of account executives that work to promote iA’s technology across North America and globally by developing long-term strategies, while also organizing and maintaining sales operations. Bobbi Jamriska, Senior Vice President, Product Management, received an award for Business Excellence. Bobbi leads the Product Management team at iA that is responsible for the iA portfolio of solutions, where she manages the strategy, development, and go-to-market planning. She has been a pharmacy tech for 12 years, and has led global product management initiatives as well as new product development experiences. Stacey Weber, Senior Director of Customer Operations, received an award for Business Excellence. Stacey oversees the customer support division, where she manages a team of 35 remote technicians who assist customers in using iA’s Rx fulfillment solutions, which include automated prescription filling robots and innovative warehouse management systems. In addition to ensuring customers receive timely and helpful assistance, she also oversees standardization and process improvement for iA’s call center and for the customers that use iA solutions. “We are incredibly proud of our team members. Rachael, Bobbi, and Stacey all represent the best of iA, and we are very lucky to be able to work with them every day.” Tom Utech, President and Chief Operating Officer About iA iA is a leading-edge provider of software-enabled pharmacy fulfillment solutions. With over 30 years in pharmacy fulfillment, iA has invented and developed a suite of software-driven pharmacy automation solutions. From NEXiA software to automated modular hardware and sophisticated counting and collation devices, iA pharmacy automation solutions and technology empower pharmacists. iA can run the prescription fulfillment process from end to end, helping pharmacies manage fulfillment and inventory to help lower costs, improve efficiency and provide comprehensive Rx tracking and real-time support.

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BUSINESS INSIGHTS, PHARMACY MARKET

Annogen Announces Research Project with Pfizer to Test Non-coding Genetic Sequences

Annogen | December 14, 2022

Annogen, the Amsterdam based biotech company behind the SuRE™ technology for the functional annotation of the non-coding part of the genome, today announced it has begun a research project with Pfizer to functionally test tens of thousands of disease-related non-coding sequence variants for their effect on gene regulation. The results may contribute to drug discovery by identifying functionally relevant non-coding variants that play a central role in diseases. More than 95 percent of disease- and trait-related variants are found in the non-coding genome. However, identifying the important causal variants amongst the thousands of non-functional ones is a major challenge, as non-coding variant functionality cannot be deduced from sequence alone. Using its SuRE™ methodology, Annogen can obtain a functional read-out for up to millions of non-coding variants in parallel. “We are very proud of this research project with Pfizer. We believe the non-coding part of the genome represents a huge opportunity for drug discovery that has been largely overlooked. We are now working with several top-tier biopharma companies on a broad array of projects, which demonstrates the interest in the SuRE™ platform and the AIM™ service for gene & cell therapy, drug discovery, and recombinant protein production”. Joris van Arensbergen, Annogen’s founder and CEO, is pleased to establish another project in this field About Annogen At Annogen we use our SuRE™ technology to identify regulatory DNA elements to be used for controlled gene expression valuable for gene & cell therapy, as well as for recombinant protein production. In addition, we offer the AIM™ service to identify favorable gene insertions and their expression levels for more than 100,000 integrations in parallel. These approaches enable researchers to qualitatively interpret the non-coding genome in humans, animals and plants.

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BUSINESS INSIGHTS

Cambrex to Acquire Snapdragon Chemistry, a Leader in Continuous Flow API Development Services

Cambrex | November 22, 2022

Cambrex, a leading global contract development and manufacturing organization providing drug substance, drug product, and analytical services across the entire drug lifecycle, today announced that it has entered into a definitive agreement to acquire Snapdragon Chemistry, a leading US-based provider of chemical process development services to a broad range of emerging and established biopharma customers. Snapdragon specializes in active pharmaceutical ingredient batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges. The team of scientists and engineers apply deep process understanding afforded by data-rich experimentation to design and rapidly execute efficient GMP and non-GMP manufacturing processes. With R&D and manufacturing headquartered in Waltham, Massachusetts, Snapdragon's 74 employees come with strong ties to the local scientific community, with 31 PhD scientists on staff. "The acquisition of Snapdragon will accelerate our growth in the area of continuous flow process development and manufacturing, complementing our recent organic investments in our High Point, North Carolina facility. With R&D and manufacturing capabilities in the heart of Boston's biopharma hub, Snapdragon will continue to focus on solving their customers' most difficult process development challenges." Tom Loewald, CEO of Cambrex "We are excited to be joining Cambrex, a company with over 40 years of drug substance development and manufacturing expertise," said Matt Bio, CEO of Snapdragon. "Partnering our best-in-class process development capabilities with Cambrex's larger scale manufacturing facilities in North America and Europe is a natural fit, both for our employees and our customers." Snapdragon recently opened its second facility, a new 51,000-square-foot facility to manufacture experimental pharmaceutical products for human clinical trials. The new facility expanded the company's capacity for supplying clinical intermediates and drug substances. The transaction is expected to close following the completion of customary regulatory approvals. This will be Cambrex's second acquisition within a year along with Q1 Scientific, consistent with its strategy to expand its portfolio of specialized solutions for pharmaceutical development and manufacturing. About Cambrex Cambrex is a leading global contract development and manufacturing organization that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,300 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing. Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.

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