Gilead Launches Two Phase III Trials of Remdesivir for COVID-19

BioSpace: | February 27, 2020

Gilead Sciences, based in Foster City, California, announced it will launch two Phase III clinical trials of its investigational antiviral drug remdesivir in adults diagnosed with COVID-19, the disease caused by the novel coronavirus. The outbreak began in China in December and has since spread through much of the rest of the world, with most cases concentrated in Asia. The current number of confirmed cases worldwide is greater than 81,400 with a total death count of 2,770. The first cases of community spread of the virus—meaning not by someone who visited Asia recently—in the U.S. was reported yesterday.

Spotlight

The United States defines a rare disease as a condition affecting fewer than 200,000 people in the
country or one in which “there is no reasonable expectation” of recovering research and
development costs.1 Examples of rare diseases include genetically-linked cancers, cystic fibrosis,
and debilitating pediatric conditions like Gaucher disease and spinal muscular atrophy

Spotlight

The United States defines a rare disease as a condition affecting fewer than 200,000 people in the
country or one in which “there is no reasonable expectation” of recovering research and
development costs.1 Examples of rare diseases include genetically-linked cancers, cystic fibrosis,
and debilitating pediatric conditions like Gaucher disease and spinal muscular atrophy

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CASI PHARMACEUTICALS ANNOUNCES EXIT OF JUVENTAS INVESTMENT TO STRENGTHEN BALANCE SHEET

CASI Pharmaceuticals, Inc. | September 26, 2022

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PHARMACY MARKET

Baseball Legend John Smoltz Featured on PLx Pharma’s Social Channels

PLx Pharma Inc. | September 13, 2022

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Stevanato Group and Gerresheimer AG Announce Collaboration on the Development of an Innovative Ready-To-Use Vial Platform

Gerresheimer and Stevanato Group | September 08, 2022

Stevanato Group S.p.A. a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, and Gerresheimer AG, a leading global provider of healthcare & beauty and drug delivery systems for pharma, biotech and cosmetics, announce that they have jointly developed a high-end Ready-To-Use (RTU) solution platform with an initial focus on vials, based on Stevanato Group’s market-leading EZ-fill® technology. This collaboration is projected to help customers gain efficiencies, improve the quality standard, increase speed to market, reduce total cost of ownership (TCO) and help mitigate supply chain risk. Stevanato Group and Gerresheimer AG are addressing rising demand for RTU vials in the market and the partnership serves as a market enabler to fully support customers’ evolving needs and establish a gold standard in the industrial filling process. The collaboration aims to make RTU vials a standard, available to a wide number of pharma companies globally – offering premium quality solutions to patients and reducing complexity for pharma operations. The new solution will be available to other players in the market to standardize fill-finish operations from early phase drug development to commercialization. The new RTU solution platform from Stevanato Group and Gerresheimer AG will share the same secondary packaging, production process and sterilization method, ensuring consistent available capacity and a reliable double sourcing to the pharmaceutical industry. A hallmark of the new RTU platform is a significant reduction in particles, improving the overall quality and performance of the RTU solutions. In addition, customers can count on a high-end solution made by two major players in the drug containment industry with a long history of innovation. The new jointly developed vial platform and trademark will be presented in detail to the market at the CPhI Worldwide in Frankfurt in November 2022. “Our EZ-fill® vial platform is the market’s most established choice for pre-sterilized containers, and this enhanced version for RTU vials will bring to the market its full potential in terms of quality, flexibility and value for Pharmaceutical Companies and CMOs. Through our collaboration with Gerresheimer AG we are responding to market demand, and we expect to achieve another important milestone in creating a reliable ecosystem to support, accelerate and de-risk the conversion from bulk to EZ-fill® vials already underway in the market.” Mauro Stocchi, Chief Business Officer at Stevanato Group “The new developed RTU vial platform stands out in terms of quality, TCO and sustainability and takes the use of RTU solutions like vials and, in the future, cartridges to a new level,” said Dr. Lukas Burkhardt, Member of the Management Board of Gerresheimer AG. "Due to the strong reduction of the particle load, the quality is significantly increased. Our new innovative solution will convince the market to significantly accelerate the conversion from bulk to RTU vials.” About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. About Gerresheimer AG Gerresheimer AG is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the commercial product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2021 of around EUR 1.5b. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

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