Patient successfully treated for coronavirus in the US

Pharmafile: Home | February 11, 2020

The Ebola drug Remdesivir, made by Gilead Sciences, was given to an American who is 35 years old. The doctors reported that on 26 January his condition seemed to improve within a day, and by 30 January it had resolved most of the symptoms except a cough. However, Gilead feel this is not conclusive proof that it's an effective treatment. Ryan McKeel, a spokesperson for the company, said: “We do not have an appropriately robust understanding of the effect of this drug to warrant broad use at this time.” Timoth Sheahan, Assistant Professor of epidemiology at the Gillings School of Global Public Health at the University of North Carolina, has also called for further research saying: “I think starting a clinical trial is essential for determining if this drug will work.”

Spotlight

In 2015 Boehringer Ingelheim UK set out on a pioneering journey with two clear aims in mind. One was to define what it means for a pharmaceutical company to be patient centric and, the second, to generate a broad set of internal and external measures to systematically quantify that.

Spotlight

In 2015 Boehringer Ingelheim UK set out on a pioneering journey with two clear aims in mind. One was to define what it means for a pharmaceutical company to be patient centric and, the second, to generate a broad set of internal and external measures to systematically quantify that.

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RESEARCH

Parexel and Veeva Collaborate to Speed-Up Clinical Trials

Parexel, Veeva Systems | May 04, 2021

Parexel and Veeva Systems announced a strategic partnership today to accelerate clinical trials through technological and process innovation. The unique partnership blends the best of each company's expertise through thousands of tests worldwide – Parexel as a pioneering CRO and Veeva as the technological innovator powering trials – to boost study performance and bring innovative therapies to patients faster. Parexel is standardizing Veeva's suite of clinical operations software, including Veeva Vault eTMF, Vault CTMS, and Vault Study Startup, as part of the agreement to streamline operations. Parexel's clients will now have access to Veeva Vault CDMS for clinical data storage as a free product. The companies will work together to continually develop Veeva's cloud technology and Parexel's clinical trial delivery processes based on the insights from sponsors, sites, and patients. Parexel will provide early access to and give feedback on Veeva's clinical products, such as innovations to support sites and patients in decentralized clinical trials (DCT), risk-based quality management (RBQM), and community-based sites. "By implementing Veeva's clinical solutions, we can streamline trial procedures, increase performance, and make trial implementation and attendance simpler for promoters, locations, and patients," Parexel CEO Jamie Macdonald said. "Through this extended relationship with Veeva, we hope to have more value to customers and have a much greater effect on the lives of patients." "We're happy to work with Parexel to fuel customer success and accelerate clinical research innovation," said Peter Gassner, Veeva's founder, and CEO. "By working together, we will help our customers get new vaccines, diagnostics, devices, and therapies to patients in need" About Parexel Parexel encourages the development of new innovative drugs to improve patient health. It provides services to clients in the life sciences and biopharmaceutical industries all over the world to help them transform scientific discoveries into new treatments. The therapeutic, technological, and functional ability is underpinned by a strong conviction in what we do, from decentralized clinical trials to regulatory advisory services to exploiting real-world insights. An independent council for Informa Pharma Intelligence voted Parexel the "Best Contract Research Organization" in December 2020. About Veeva Systems Veeva is the world's leading provider of cloud software for the life sciences industry. Veeva represents over 975 clients, ranging from the world's leading pharmaceutical firms to new biotechs, and is dedicated to innovation, product excellence, and customer success. Veeva is committed to balancing the needs of all stakeholders, including customers, employees, shareholders, and the industries it serves, as a Public Benefit Corporation.

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PRACTICE MANAGEMENT

Azurity Pharmaceuticals to Acquire and Merge with Arbor Pharmaceuticals

Azurity Pharmaceuticals, Inc. | August 24, 2021

Azurity Pharmaceuticals, Inc. and Arbor Pharmaceuticals, Inc. today announced they have entered into a definitive agreement in which Azurity will be acquiring Arbor from existing investors including JW Asset Management and KKR. Following the completion of the transaction, which is subject to regulatory approvals, Azurity and Arbor will merge, creating a leading company offering innovative, high-value products to meet the unique needs of patients with underserved conditions. Financial details of the transaction were not disclosed. “I am proud of the business that our team has built over the last ten years and am confident that the combined entity will enhance our success and provide more treatment options for patients.” “Arbor is excited to be joining forces with Azurity to further our goal of bringing innovative products to the market that improve patients’ lives,” commented Ed Schutter, CEO of Arbor. “I am proud of the business that our team has built over the last ten years and am confident that the combined entity will enhance our success and provide more treatment options for patients.” The combined company, operating as Azurity, will have a portfolio of products serving the unmet needs of patients in the cardiovascular, central nervous system, endocrinological, gastrointestinal, and institutional markets. Azurity will build upon each company’s legacy of success through a distinctive portfolio of 10 exclusively promoted, FDA-approved, branded product families, more than 30 total commercialized products, and a robust pipeline of mid and late-stage products under development. Azurity will continue to develop and commercialize its portfolio of products and deliver them at the right time, in the right way, to the right patients, through a spectrum of healthcare professionals. “We are proud to continue our partnership with Azurity,” said Jeff Edwards, Partner at NovaQuest Private Equity, the majority owner of Azurity. “This combination accelerates our shared vision of building the leading patient-centric company that differentiates itself by bringing distinctive, high-value products that meet the unique needs of our patients, through state-of-the-art innovation and commercialization capabilities.” “Today is a tremendous milestone for both Arbor and Azurity, and a strong validation of the products that they provide to patients in need,” said Jason Wild, Chairman of Arbor and Chief Investment Officer of JW Asset Management. “We are proud to have supported Arbor and its management team and are excited for the company’s next phase of growth in partnership with Azurity,” added Ali Satvat, Co-Head of Americas Health Care Private Equity and Global Head of Health Care Strategic Growth at KKR. JPMorgan Chase Bank, N.A. and Truist Securities, Inc. are financing sources for the transaction for Azurity. Smith Anderson served as legal advisor to Azurity. MTS Health Partners, L.P. served as exclusive sell-side financial advisor and King & Spalding served as legal advisor to Arbor. Simpson Thacher & Bartlett LLP served as legal advisor to KKR. Pending regulatory approvals, the companies anticipate closing the transaction in September. About Azurity Pharmaceuticals: Azurity Pharmaceuticals is a privately-held, specialty pharmaceutical company focusing on the needs of patients requiring customized, user-friendly drug formulations and dosage forms. Azurity’s patient centric products span the cardiovascular, neurology, gastro-intestinal and institutional markets. Azurity’s products have benefited millions of patients for which conventional oral dosage forms are not ideal and whose needs are not served by other commercially available therapies. About Arbor Pharmaceuticals: Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company marketing FDA-approved prescription products in the neuroscience, cardiovascular, and institutional markets. In addition to an extensive pipeline, the company actively pursues growth through acquisition and licensing of late-stage development products. About NovaQuest Private Equity: NovaQuest Private Equity is a leading investor in technology and services companies in the life sciences and healthcare sectors. NovaQuest was formed in 2000 with the vision of building an investment platform to provide strategic capital and operational leverage in partnership with strong management teams. The investment team consists of highly seasoned operational and investment professionals with significant investment experience and deep life science and healthcare expertise. Furthermore, NovaQuest benefits from an extensive network of industry experts and relationships that assist in identifying, analyzing and growing NovaQuest portfolio companies and investments. About JW Asset Management: JW Asset Management is a New York based fund manager with combined assets under management in excess of $1.5 billion. Jason Wild, the firm’s founder and Chief Investment Officer, is a registered pharmacist and Chairman of Arbor Pharmaceuticals and TerrAscend Corp. JW Asset Management has a history of finding attractive investment opportunities and actively invests in both public and private markets. About KKR: KKR is a leading global investment firm that offers alternative asset management and capital markets and insurance solutions. KKR aims to generate attractive investment returns by following a patient and disciplined investment approach, employing world-class people, and supporting growth in its portfolio companies and communities. KKR sponsors investment funds that invest in private equity, credit and real assets and has strategic partners that manage hedge funds. KKR’s insurance subsidiaries offer retirement, life and reinsurance products under the management of The Global Atlantic Financial Group. References to KKR’s investments may include the activities of its sponsored funds and insurance subsidiaries.

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PHARMA TECH

Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

Pfizer | December 21, 2020

Since the time Pfizer was fixed to partake in the U.S. government's Warp Speed exertion to get COVID-19 antibodies to showcase, the organization has made it very clear it didn't have to take any bureaucratic cash to build up the immunization. In any case, did that refusal of R&D subsidizing add to Pfizer's failure to produce more dosages of its mRNA antibody for the U.S. market? Pfizer could give more than the 100 million portions it guaranteed in its unique agreement with the U.S. government in the main portion of one year from now—however just if Trump organization authorities request that providers of crude materials rapidly satisfy the organization's requests. Furthermore, CEO Albert Bourla, Ph.D., is approaching the public authority to utilize the Defense Production Act to do precisely that. The Trump organization hasn't done as such yet on the grounds that they've zeroed in on giving those materials to antibody producers that took government R&D subsidizing, as Moderna, as indicated by anonymous sources who addressed The New York Times. A representative for Pfizer declined to remark, refering to the privacy of conversations with the U.S. government. Yet, Bourla said during a CNBC meet that the organization is in exchanges to sell an extra 100 million dosages of Pfizer's COVID-19 immunization to the U.S. government. "We can give a ton of that in the second from last quarter. The U.S. government needs it in the subsequent quarter," Bourla said in the Monday meet. "We are working cooperatively to attempt to discover an answer and have the option to apportion those 100 million [doses] in the subsequent quarter if conceivable, or a ton of them." Pfizer mentioned almost immediately that the public authority grant it "supported status" with providers of crude materials, however authorities were anxious about the possibility that that would harm contending immunization programs that took government R&D cash, as per the Times report. Among those organizations is Moderna, which is required to win crisis use approval from the FDA for its mRNA immunization this week—and last Friday, inked an arrangement to add 100 million additional portions to its underlying U.S. request.

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