Study identifies a hormone that may hinder weight loss

medicalnewstoday | April 23, 2019

A series of experiments in mice demonstrates that a well-known hormone might have a previously unidentified role in the metabolic response to energy restriction during weight loss. Scientists have known about growth hormone (GH) for several decades. It plays a role in bone growth and is particularly important as our bodies grow. It also helps maintain organs and tissues as we go through our adult lives. However, researchers at the University of São Paulo in Brazil have found an entirely new and unexpected role for GH: It appears to play a part in energy conservation during weight loss. José Donato Junior and his team published their findings in the journal Nature Communications.

Spotlight

Christopher R. Anzalone, PhD, President, CEO and Director of Arrowhead Pharmaceuticals, presents at Master Investor 2016. Arrowhead develops medicines that treat intractable diseases by silencing the genes that cause them. The company uses RNAi-based therapeutics to leverage the natural pathway of gene silencing…


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BUSINESS INSIGHTS

BD Completes Acquisition of Parata Systems

BD | July 19, 2022

BD announced it has completed the acquisition of Parata Systems. Parata advances BD's transformative solutions strategy by providing a portfolio of innovative pharmacy automation solutions that power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience for retail, hospital and long-term care pharmacies. As a combined company, BD is positioned to offer a comprehensive set of technologies to the $600 million pharmacy automation market segment that is expected to grow approximately 10% annually to $1.5 billion in the U.S. alone over 10 years. "Completing this acquisition represents an important step towards advancing our 2025 growth strategy around smart, connected care and enabling new care settings. I'd like to officially welcome the Parata team to BD as we join together to uniquely provide a more comprehensive set of smart, connected care technologies to support our customers as they expand care to new settings and centralize their pharmacy operations." Tom Polen, chairman, chief executive officer and president of BD The acquisition builds on BD's legacy and experience of seamlessly integrating teams to drive future growth and innovation. The Parata portfolio will become part of the solutions offered by BD's Medication Management Solutions business within the BD Medical segment. Together, the combined BD and Parata team will help pharmacy leaders address critical trends, such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacy staff. About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

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VIEWS AND ANALYSIS

Enteris BioPharma Publishes White Paper Examining Factors to Consider While Evaluating Oral Administration of Peptides

Enteris BioPharma | September 13, 2022

Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation announced the publication of a new white paper in Drug Development & Delivery entitled, "Key Considerations in Oral Delivery of Peptides – Factors to Consider While Evaluating Oral Administration." The paper, authored by John Vrettos, PhD, Director of Formulation Development for Enteris BioPharma, and Kalpana Ramakrishnan, PhD, Manager of Business Development for Enteris BioPharma, explores the barriers to developing oral delivery of peptides and how pharmaceutical companies can overcome them. Oral administration of peptides offers several advantages while treating chronic conditions such as diabetes and obesity as they are less invasive and more cost effective compared to injections. "Molecule size, potency, and solubility are some of the key physicochemical properties that determine a peptide's suitability for oral delivery. The healthcare industry is in need of enabling drug delivery technologies with the capability to overcome barriers in oral delivery of peptides. Importantly, orally delivered medications may encourage patient compliance compared with more invasive approaches to administering drugs. Approximately 75% of peptides are delivered by injective routes, including subcutaneous injections which can be painful and difficult to incorporate into a daily routine." Dr. Vrettos Dr. Vrettos continued, "Enteris' Peptelligence® platform offers a 'triple-action' solution comprised of our enteric coating, protease inhibitor, and permeation enhancer. When combined, these technologies have demonstrated an ability to improve the solubility and permeation of orally delivered peptides. These properties can potentially enable oral delivery of some peptide drugs for the first time, and we are excited to share our knowledge on oral delivery of peptides through this informative whitepaper." Peptelligence is a novel formulation technology designed to enhance the oral delivery and bioavailability of selected drugs by enhancing the permeation of such compounds that are typically injected, including peptides and BCS class III and IV small molecules, and preventing their breakdown in the digestive tract. About Enteris BioPharma Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation offering total integrated contract development and manufacturing services for innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence® and ProPerma®, and contract manufacturing (CMO) services using non-proprietary technologies. The company's proprietary technologies have been the subject of numerous feasibility studies and active development programs, some of which are in clinical development. Additionally, Enteris BioPharma is advancing an innovative internal product pipeline of drug products that address significant unmet clinical needs for which there is no satisfactory treatment option.

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PHARMA TECH

ArisGlobal's LifeSphere Regulatory IDMP Product Leader Invited to Chair American National Standards Institute Global MPID Project

ArisGlobal | August 23, 2022

ArisGlobal, the leading provider of life sciences software that automates core drug development functions with its end-to-end technology platform LifeSphere®, today recognizes and applauds the accomplishments of their LifeSphere® Regulatory IDMP product leader, Robin Schilling, for her acceptance into American National Standards Institute (ANSI) and the nonprofit's specific ISO Health Informatics Technical Committee, Working Group 6, which helps develop standardizations for Pharmacy and Medicines Business. ANSI is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. Schilling is the product owner of LifeSphere IDMP, a solution recognized by analyst group Gens & Associates as leading in IDMP Readiness. Schilling's work with ANSI Working Group 6 will include chairing a committee to lead the effort in developing a global Medicinal Product ID under the IDMP umbrella to help improve the efficiency and resilience of the supply chain. IDMP is scheduled to go live in the European Union (EU). The regulation pertains to all companies who are doing business within the EU, not just those who are based there. Both the work being done by ANSI and the EMA will help improve drug and patient safety, while encouraging a global dialogue around drug development. "It is in incredible honor to be a part of the American National Standards Institute and Working Group 6," shares Schilling. "Having a seat at the table to discuss these core, pressing matters in R&D will help improve drug safety, reduce drug shortages, and mitigate supply chain risks by allowing manufactured products and ingredients to be tracked down to the lot level. It's a tremendous move in the right direction and towards continued, growing regulation that keeps patient safety at the center of medicinal products." "Our people are at the heart and soul of what we do, so to have an organization like ANSI recognize the talent and impact Robin Schilling has in the standards and regulations space is well-deserved and commendable. Robin is an excellent example of the incredible talent we have at ArisGlobal. She is a leader on our Regulatory team and has such a robust professional background, we are confident she will do great things and continue to make an impact in our organization and beyond." Clint Wolfe, Chief Human Resource Officer at ArisGlobal About ArisGlobal ArisGlobal is transforming the way today's most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture. About LifeSphere® LifeSphere is the trusted partner for global pharmaceutical and biotechnology companies, health authorities, and contract research organizations. Helping accelerate product development, organize clinical trials, manage compliance, and streamline collaboration across teams, LifeSphere empowers safer, faster life science breakthroughs. As the flagship product of ArisGlobal, LifeSphere is a market-leading solution built on 40 years of industry partnership and continues to evolve in collaboration with hundreds of trusted customers.

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PHARMA TECH

AeroRx Partners with HCmed to Develop a Nebulized LABA/LAMA Combination Solution for the Treatment of Chronic Obstructive Pulmonary Disease

AeroRx Partners | October 03, 2022

AeroRx Therapeutics, LLC. and HCmed Innovations Co., Ltd. have initiated a collaboration, introducing a LABA/LAMA combination solution for delivery with a breath-actuated nebulizer. This collaboration sets forth the framework by which both companies will work together to develop a new nebulized combination formulation for the treatment of chronic obstructive pulmonary disease. According to market reports, it is estimated that there would be close to 34.5 million COPD patients worldwide by 2028, accounting for treatment global sales that could reach up to 19.3 billion USD. AeroRx is currently developing the first nebulized LABA/LAMA combination solution, which could benefit 7-19% of the COPD population. This population group is characterized for suffering from moderate to severe airflow obstruction, which creates difficulties to achieve the inspiratory flow rate required to use most dry powder inhalers optimally. Under this partnership, AeroRx will be responsible for the formulation development, clinical trials, and commercialization of the drug product, while HCmed will be responsible for the customization of the AdheResp breath-actuated nebulizer platform, analyzing and optimizing the formulation's aerosol characterization performance to accommodate the various stages of drug development process and the final combination product. The project will follow a 505(b)2 regulatory pathway, and the corresponding PK/PD study is expected to be conducted with HCmed's nebulizer in 2023. "We are excited to announce our partnership with AeroRx. The AeroRx team has extensive experience in the development of respiratory drugs, while at HCmed we can support our partners to develop drug-nebulizer combination products with our proprietary breath-actuated mesh nebulizer platform. The product of our collaboration will provide COPD patients with an effective inhaled LABA/LAMA combination drug, which will reinforce patients' treatment adherence and improve their quality of life." Jason Cheng, CEO and founder of HCmed Keith Ung, President and co-founder of AeroRx also commented, "We too are enthusiastic about this partnership. Breath-actuated vibrating mesh delivery of inhaled therapeutics is the wave of the future for many therapeutics and HCmed has become one of the leaders in this elegant inhaler device technology." About HCmed Founded in 2014, HCmed Innovations Co., Ltd. is a contract development and manufacturing organization that provides high-quality and cost-effective vibrating mesh nebulizer technology and services to support global pharmaceutical partners in the development of drug-nebulizer combination products for inhalation therapy. HCmed offers a mature customizable mesh nebulizer platform to enhance drug delivery. This technology enables efficient and reliable nebulization of different types of medication, ranging from small molecule synthetics to large molecule biologics, as either solutions, suspensions, or even difficult-to-deliver high viscosity drugs. About AeroRx Founded in 2022, AeroRx Therapeutics, LLC. is a spin-off of iPharma Lab's inhalation CDRO business which was recently acquired by Kindeva Drug Delivery. AeroRx is developing proprietary inhaled products for the treatment of COPD and asthma. The company is led by industry veterans with extensive expertise in inhaled drug delivery and development as well as a track record in building new pharmaceuticals organizations from the ground up.

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Spotlight

Christopher R. Anzalone, PhD, President, CEO and Director of Arrowhead Pharmaceuticals, presents at Master Investor 2016. Arrowhead develops medicines that treat intractable diseases by silencing the genes that cause them. The company uses RNAi-based therapeutics to leverage the natural pathway of gene silencing…

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