Hi-Tech Responds to "Bullying Tactics" Issued by FDA Warning Letter on DMHA

biospace | April 17, 2019

Hi-Tech Pharmaceuticals once again states that FDA's attempt to quasi ban a product by warning letter rather than rulemaking is not the law. Hi-Tech is working on a response to the agency but wanted consumers to know Hi-Tech will not just roll over due to an ill informed warning letter. Hi-Tech Pharmaceuticals was forced to sue the FDA November 5th, 2013 in Federal Court because the agency bypassed standard rule-making procedures in favor of a bullying campaign to try to force companies to destroy their products containing DMAA. Now the agency has engaged in the exact same tactics with DMHA it resorted to with DMAA, that is now the center of a 5 year battle between Hi-Tech and FDA that is just waiting a ruling by the 11th Circuit Court of Appeals.2-amino-5-methylheptane, 2-amino-6-methylheptane, 2-heptanamine,5-methyl-, Octodrine is a stimulant compound naturally found in Walnut Bark extract, or the bark from the Juglans Regia tree. It is also found in the fruit in Kigelia africana Extracts and is often considered to exert its influence as a decongestant and bronchodilator. 2-amino-5-methylheptane shares functions such as the support of energy levels, acting as widening of the bronchi for more air flow, and constricting the blood vessels for decreased swelling (better ability to breathe).

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Exscientia Highlights "The Future of AI-enabled Drug Discovery" at SLAS Europe

Businesswire | May 23, 2023

Exscientia plc announced two abstracts for oral and poster presentation, as well as the closing keynote to be delivered at the Society for Laboratory Automation and Screening (SLAS) Europe Conference and Exhibition being held May 22-26, 2023, in Brussels, Belgium. These presentations highlight Exscientia’s recent advancements in technology, including the development of computer-aided biology (CAB) approaches, encompassing design of experiments (DoE) and automation for biochemical assay optimisation. The SLAS Conference is Europe’s premiere venue for industry, government and academic researchers, developers and providers of laboratory automation technology innovation. “At Exscientia, our mission is to encode and automate drug discovery. We believe that within this decade the design of all new drug candidates will be augmented with AI. I am delighted to showcase at SLAS Europe how our recent technology advances enable and drive our projects,” said Dr Garry Pairaudeau, Chief Technology Officer at Exscientia. Integrating laboratory automation of synthesis and screening with its AI-driven computational design platform is the logical next step for the company. “This will facilitate the next transformation in speed and productivity, as we aim to bring better medicines to patients faster. We’re looking forward to opening our purpose-built automation studio in Oxfordshire, U.K., later in 2023.” The company’s presentation at SLAS will demonstrate how far along Exscientia is in automating the drug discovery processes. “We believe automation has the potential to radically improve the timely creation of high-quality drug candidates, so that future patients may benefit from innovative science faster,” Pairaudeau stated. Closing Keynote Presentation Title: The future of AI-enabled drug discovery Room/Location: Plenary Theater Date/Time: Thursday, May 25 / 16:30 – 17:30 PM CET This presentation will highlight Exscientia’s distinct approach to molecular design, using an end-to-end patient centric, AI-enabled platform, which has led the way in the precision design of AI-generated molecules resulting in the first AI-designed compounds to enter clinical trials. To reach Exscientia's goal of fully encoding and automating drug discovery, the company is assembling an automated physical laboratory alongside its suite of sophisticated computational design tools, methods and scalable engineering platform. This presentation will highlight Exscientia's current progress in the automation field and the critical steps needed in the implementation of automated, digital laboratories. Abstracts Accepted for Presentation Oral Presentation Title: Computer-aided biology: DoE solutions Track: Frontiers in Technology Room/Location: 231 Date/Time: Thursday, May 25 / 15:30 – 16:00 PM CET Exscientia is building an automated ecosystem of chemistry, biology and compound management, including developing a pipeline of fully automated biochemical assays from assay development onwards. This presentation highlights how CAB has been leveraged to achieve this pipeline, combining DoE (a statistical methodology) with automation to rapidly determine optimum conditions to run assays efficiently through analysis of multi-factorial experimental results. Utilising CAB also allows Exscientia to increase capacity and efficiency across FTEs, time and reagents required to run assays, increase assay robustness and investigate areas of biology not normally studied. Poster Title: Improving assay optimisation and pharmacological sensitivity of a nuclease by employing a computer-aided biology approach Session/Track: Session A; Frontiers in Technology Abstract Number: 1034-A Date/Time: Wednesday, May 24 / 13:30 – 14:30 PM Exscientia researchers demonstrated the practical use of CAB to simultaneously improve an assay’s performance and reduce the reagent requirement, cost and labour for assay development. This presentation highlights the application of CAB to optimise the buffer of a nuclease assay, resulting in a 15-fold enhanced assay signal in low salt buffer conditions, alongside over a three-fold decrease in protein requirement​ and reduced assay development cycle times. The low salt requirement is a previously unforeseen result from CAB use which would have not been predicted from the literature. This highlights the potential for technology to improve assay performance in ways a human alone would not have been able to predict. About Exscientia Exscientia is an AI-driven precision medicine company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. Our internal pipeline is focused on leveraging our precision medicine platform in oncology, while our partnered pipeline broadens our approach to other therapeutic areas. By pioneering a new approach to medicine creation, we believe the best ideas of science can rapidly become the best medicines for patients.

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BUSINESS INSIGHTS, PHARMACY MARKET

Endo Launches Authorized Generic Version of Noxafil® (posaconazole) Oral Suspension

Prnewswire | April 04, 2023

Endo International plc announced that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping the authorized generic (AG) version of Merck's Noxafil® (posaconazole) 200 mg/5 mL oral suspension in the U.S. "Our partnership with Merck underscores our reputation as an industry-leading supplier," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "This newly available Noxafil® AG dosage form is the latest addition to our generics portfolio—providing patient access to high-quality, lower-cost treatment options." Endo subsidiary Endo Ventures Limited entered into an exclusive U.S. supply and distribution agreement with a subsidiary of Merck & Co., Inc. of Rahway, N.J. allowing Par to launch and distribute an authorized generic version of the product. The agreement also included the authorized generic version of Noxafil® delayed-release tablets, 100 mg, which launched in 2019. Noxafil® is a registered trademark of Merck Sharp & Dohme LLC. About Endo International plc Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them.

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BUSINESS INSIGHTS, PHARMACY MARKET

PCI Pharma Services Announces New Sterile Fill-Finish Capabilities Now Available in Melbourne and San Diego

Businesswire | April 24, 2023

PCI Pharma Services a leading global contract development and manufacturing organization announced that three new state-of-the-art automated sterile fill-finish machines at its San Diego and Melbourne facilities are now fully operational. The innovative machinery from Cytiva can be used to fill various sterile medications into vials and syringes for small-to-mid scale client needs. The equipment, paired with PCI’s end-to-end services, accelerates Speed to Study™, and drastically decreases the average turnaround time from proposal signing to the injectable product’s distribution. “As the capacity for CDMOs worldwide to take on new projects shrinks, we’re excited to be able to offer integrated sterile fill-finish capabilities, alongside our clinical packaging facilities, to new and existing clients in Melbourne and San Diego,” said Brad Payne, Chief Operating Officer, PCI Pharma Services. “Our increased capacity, stockpile of standardized components, including glass, and technical expertise means we can start running batches as soon as needed. This will cut down on the wait times many pharmaceutical companies are facing and begin to help alleviate the global capacity shortage for sterile drug product and downstream packaging.” The Microcell Vial Filler and SA25 Aseptic Filling Workcell at PCI’s San Diego facility ensures the delivery of medicines from phase I through phase III, supporting local and global Clinical client needs. Additionally, a Microcell Vial Filler at Melbourne further enhances the early-stage services offered and brings additional capacity to Australia—the world’s leading phase I environment. These advanced machines expedite the filling process with automation and remove the need for human intervention in a sterile environment, creating compliance advantages over standard equipment. “There are less barriers to entry to start a clinical trial in Australia, as well as significant cost benefits, and with Melbourne being an especially popular place to conduct phase I trials, we knew we needed to bring this capability and added capacity to the local market,” said Tim Roberts, Chief Commercial Officer, PCI Pharma Services. “In addition, we are then able to take our clients through their lifecycle journeys with the expansions and advanced capabilities in our New Hampshire and Madison campuses. With successful recent inspections at our Bedford facility by the Brazilian (ANVISA) and Japanese (PDMA) regulatory authorities, our global reach to supply life-changing therapies to patients quickly and safely is wider than before.” To better support its clients throughout the world, PCI has also recently invested in expansions in Rockford, IL, and Tredegar, Wales, as well as established new facilities in Bedford, NH, and Bridgewater, MA. About PCI Pharma Services PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain) and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.

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