Early missteps, transparency questions dog U.S. government's remdesivir rollout: reports

Fiercepharma | May 08, 2020

When there’s only one proven therapy for a global pandemic that’s infected millions—and a limited initial supply—how exactly should officials distribute it? So far, the U.S. government hasn't figured it out, reports say. When Gilead Sciences scored its groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the federal government. But the rollout has gotten off to a rocky start, according to reports. The medicine—the only one so far to demonstrate positive controlled results against COVID-19—hasn’t gone to certain high-priority hospitals that needed it most, Axios reports. Instead, some remdesivir doses “went to the wrong places,” an unnamed senior Trump administration told the publication.

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Over 36 million Americans practice yoga. Studies show it can improve flexibility, which in turn can help treat and prevent back pain. Yoga has also been shown to lower inflammation, which is linked to serious issues like cardiovascular disease and cancer. Studies also suggest it might reduce stress by interfering with your brain’s ability to release stress hormones.

Spotlight

Over 36 million Americans practice yoga. Studies show it can improve flexibility, which in turn can help treat and prevent back pain. Yoga has also been shown to lower inflammation, which is linked to serious issues like cardiovascular disease and cancer. Studies also suggest it might reduce stress by interfering with your brain’s ability to release stress hormones.

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BUSINESS INSIGHTS

Societal CDMO Selected To Provide Tech Transfer And Manufacturing Services To Support Clinical Development Of An Oral Solid Dose Product In Europe

Societal CDMO, Inc. | July 21, 2022

Societal CDMO, Inc. a contract development and manufacturing organization dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected to provide CDMO services to support the ongoing clinical development of a novel drug candidate in Europe. The compound is an oral solid dose anti-viral therapy product approved for the prevention and treatment of human immunodeficiency virus in select countries in Europe and Societal’s work is focused on supporting the expansion of the product’s indications. Under terms of the new agreement, Societal CDMO will execute appropriate technology transfer activities, followed by cGMP manufacture of clinical trial material to support the initiation and execution of Phase 2 studies of the drug candidate. This work will include production, packaging and labeling of both the active compound and matching placebo for the study. “This is a key new agreement for Societal CDMO as it is a clear demonstration of the company’s ability to capitalize on the increasing interest of drug developers in the onshoring and reshoring of contract manufacturing activities to the U.S. from other regions around the globe. We are proud to be trusted by our partner to execute the tech transfer, manufacturing and packaging services that will be necessary for the initiation of its planned Phase 2 study in Europe. We continue to be pleased with our progress in leveraging our end-to-end CDMO service offerings to grow our business and expand our client base.” David Enloe, chief executive officer of Societal CDMO About Societal CDMO Societal CDMO is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.

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BUSINESS INSIGHTS

Iktos and Zealand Pharma to Develop Artificial Intelligence Technology for Peptide Drug Design

Iktos | June 22, 2022

Iktos, a company specialized in Artificial Intelligence for new drug design, announced a research collaboration with Zealand Pharma A/S a biotechnology company changing lives with innovative peptide-based medicines to co-develop generative and predictive AI technologies for peptide drug design. Iktos’ AI technology, based on a comprehensive data-driven chemical structure generation technology, brings new insights into the drug discovery process. This technology automatically designs virtual novel molecules with all the characteristics of a successful drug molecule. Iktos has recently diversified its R&D efforts into the development of an AI technology for peptide-based therapeutics and has developed state-of-the-art generative and predictive models to facilitate design of novel peptide therapeutics with desired properties. Zealand Pharma A/S has a track record of successfully inventing and developing novel peptide-based drugs. This success is based on the extensive experience in improving the therapeutic characteristics of peptides. Zealand Pharma has a keen interest in expanding its computational chemistry toolbox to include AI and machine learning based approaches for the design of novel therapeutic peptides. Under the agreement, Zealand will contribute its expertise in peptide drug discovery to Iktos’ generative modelling technologies and expertise in machine learning and AI. “We are very pleased to join forces with Zealand Pharma and leverage their deep know-how in peptide therapeutics with our state-of-the-art existing technology assets to peptide drug discovery. We look forward to working with Zealand’s experienced R&D team to build leading/state of the art peptide generative and predictive modelling technology in the field of peptides - a new area for Iktos.” Yann Gaston-Mathé, President and CEO of Iktos About IKTOS Incorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis. Iktos has recently diversified its R&D efforts into the development of an AI technology for peptide-based therapeutics and has developed state-of-the-art generative and predictive models to facilitate design of novel peptide therapeutics with desired properties.

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PHARMA TECH

Armata Pharmaceuticals Announces Clearance of IND for Prosthetic Joint Infections

Armata Pharmaceuticals, Inc | August 02, 2022

Armata Pharmaceuticals, Inc. a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that the U.S. Food and Drug Administration has cleared Armata's Investigational New Drug application for AP-SA02 in prosthetic joint infection. The company is initiating start-up activities for the Phase 1b/2a trial that will explore the safety, tolerability, and pharmacokinetics of intravenous and intra-articular doses of AP-SA02 as an adjunct to standard of care antibiotics in subjects with PJI. "Prosthetic joint infection is one of the most serious complications of prosthetic joint implantation. Staphylococcus aureus is a dominant pathogen that drives the need for surgical intervention and prolonged courses of antibiotic therapy. The ability of S. aureus to create biofilms that are refractory to standard of care antibiotics highlights the need for a novel therapy. Phage therapy may fill this need for PJI patients as phage have demonstrated the ability to disrupt biofilm and work synergistically with antibiotics." Dr. Mina Pastagia, Armata's Senior Vice President of Clinical Development "Armata is excited to explore AP-PA02 in patients who suffer from complicated joint infections that don't respond adequately to standard of care antibiotics. PJI is a logical extension of our diSArm trial which is targeting complicated S. aureus bacteremia," said Brian Varnum, Chief Executive Officer of Armata. "With this IND approval, Armata now has four active clinical programs. Today marks an important development milestone for Armata and its investors who set a course three years ago to transform phage therapy from a promising new technology to one that is explored in rigorous clinical settings." In addition to evaluating AP-SA02 in PJI and bacteremia due to S. aureus, Armata has advanced AP-PA02 into the Phase 2a component of the SWARM-P.a. study which targets chronic Pseudomonas aeruginosa infections in people with cystic fibrosis (CF). In February, the company gained IND clearance for AP-PA02 in a second indication, non-cystic fibrosis bronchiectasis targeting patients with chronic P. aeruginosa infections in a Phase 2 trial. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.

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