Open Orphan secures study trial contract with mystery pharmaceutical company

Open Orphan | August 10, 2020

Pharmaceutical services company Open Orphan has scored a £4.0m contract with an unnamed top-three global pharmaceutical company to be the sponsor of and provide a respiratory syncytial virus human challenge study trial. Open Orphan said the new contract represented the continued conversion of its substantial pipeline and generation of significant cash flow. The AIM-listed group added that the study would take place in subsidiary hVIVO's London-based quarantine unit and was expected to be completed by the end of the first quarter of 2021.

Spotlight

The US Food and Drug Administration (FDA) has approved Zejula (niraparib) as a maintenance treatment for women with certain types of recurrent cancers, including epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Spotlight

The US Food and Drug Administration (FDA) has approved Zejula (niraparib) as a maintenance treatment for women with certain types of recurrent cancers, including epithelial ovarian, fallopian tube, and primary peritoneal cancer.

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PHARMA TECH

Veeva Development Cloud Simplifies Drug Development in the Industry

Veeva Systems | May 21, 2021

A growing number of life sciences companies are adopting Veeva Development Cloud applications from Veeva Systems in an industrywide shift to streamline drug development. quite 650 companies use Veeva Development Cloud applications today, and quite 250 are leveraging multiple Veeva Vault applications across functional areas to enable and connect drug development and manufacturing teams. Veeva Development Cloud brings together suites of unified applications for clinical, regulatory, quality, and safety on one cloud platform, eliminating organizational siloes. quite 350 companies are accelerating trial execution with Vault Clinical applications, quite 250 are streamlining regulatory processes with Vault RIM, quite 350 are unifying quality management with Vault Quality, and quite 35 are improving pharmacovigilance with Vault Safety. Vault Connections in Veeva Development Cloud drive cross-functional business processes across the merchandise lifecycle. For instance, Connections enable companies to compile clinical operations and regulatory for faster submissions; quality and regulatory for simplified change control and variation management; and clinical data and operations for real-time visibility into patient enrollment. "We're dedicated to bringing innovations to plug that help the industry accelerate drug development," said Jim Reilly, vice chairman of Veeva Vault R&D. "Veeva Development Cloud is enabling customers to enhance collaboration across teams and speed the delivery of treatments to patients." About Veeva Systems Veeva is that the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves quite 975 customers, starting from the world's largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and therefore the industries it serves.

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BUSINESS INSIGHTS

Virpax Pharmaceuticals Engages Torreya Capital to Advise on Global Partnering Efforts

Torreya Capital, Virpax Pharmaceuticals | April 23, 2021

Virpax® Pharmaceuticals, Inc. reported today that it has appointed Torreya Capital, LLC as the Company's sole financial adviser for its partnering and licensing activities in strategic global markets. Torreya is a leading investment bank that has supported more than $100 billion in life sciences transactions since its establishment in 2007. “We are thrilled to be collaborating with Torreya to extend our partnerships in key markets,” said Anthony Mack, Chairman, and CEO of Virpax Pharmaceuticals. "There is an increasing worldwide need for non-opioid, non-addictive pain treatments, and we agree that our product candidates, EpoladermTM, ProbudurTM, and EnveltaTM, will provide a competitive advantage in their target markets," Mr. Mack concluded. "We look forward to assisting Virpax Pharmaceuticals in identifying strong regional partners for their innovative acute and chronic pain product candidate pipeline,” said Torreya Partner Tom Bird. "Virpax's product candidates include proprietary technologies that can enable the product candidates to provide enhanced benefits while providing non-addictive pain relief.” About Torreya Torreya is a global investment banking boutique that works with life sciences industries. Since its inception in 2007, the company has closed over $100 billion in transactions spanning branded pharmaceutical, biotechnology, generic pharmaceutical, and life sciences firms in nearly 250 assignments. Their associates are senior bankers and executives with extensive industry expertise, insights, and networks. They are a preferred advisor for businesses seeking secure, conflict-free, and knowledgeable advice on M&A, capital markets, licensing, and asset sale transactions. The breadth of Torreya's global footprint separates it from any other life sciences advisory practices. About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management product candidates by optimizing and enhancing drug delivery using its proprietary technologies. Virpax is seeking FDA approval for its three proprietary drug delivery systems. EpoladermTM is a metered-dose topical diclofenac spray film formulation being used to treat acute musculoskeletal pain and osteoarthritis. ProbudurTM is a liposomal bupivacaine formulation for a single injection that is being used to treat post-operative pain. EnveltaTM is an intranasal molecular-envelope enkephalin formulation that is being developed to treat acute and chronic pain, particularly cancer-related pain. Virpax is also developing its PES200 product candidate to treat post-traumatic stress disorder (PTSD) and its MMS019 product candidate to prevent viral replication caused by influenza or SARS-CoV-2 using its intranasal Molecular Envelope Technology (MET).

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PHARMACY MARKET

Sensyne Health and Phesi Form a Joint Commercial Development Partnership with a Leading Pharmaceutical Company

Sensyne Health, Phesi | May 24, 2021

Sensyne Health plc, the Clinical AI company, today announced that it has entered a joint commercial clinical development partnership in an undisclosed disease area with a major pharmaceutical company that is an existing client of Phesi with its U.S.-based strategic partner Phesi Inc. Sensyne and Phesi have entered into a joint commercial collaboration with a pharmaceutical customer for the first time since forming a strategic alliance in January 2021. The development work will consist of comparing anonymized and de-identified real-world patient data available to Sensyne with Phesi's clinical trial data to optimize the design of a clinical trial program for the client. This collaboration's financial terms have not been disclosed. About Sensyne – Phesi Strategic Alliance Sensyne and Phesi decided to partner on an exclusive basis to offer synthetic clinical trial arms and clinical decision support tools that combine clinical trial data with real-world patient data under the terms of the strategic partnership arrangement. Many of the world's leading pharmaceutical and biotechnology companies are among Phesi's clients. About Sensyne Health Sensyne Health plc is a clinical artificial intelligence company with a unique business model – a for-profit plc with a positive social impact that shares its financial returns with health systems. Clinical AI is used by the company in the healthcare and life science industries. Sensyne provides remote patient monitoring and real-time decision-making services of healthcare for medical institutions and their patients. Sensyne analyses large complex anonymized data sets in life sciences to assist life sciences companies in accelerating the development of new medicines. About Phesi Inc. Phesi is a profitable, privately held company headquartered in Connecticut, United States. The goal of the organization is to enable data-driven drug development and commercialization through predictive analytics powered by patient-centric data science. Phesi's integrated offerings include the entire clinical development process, from development planning and indication evaluation to protocol evaluation and design (including a synthetic control arm), site selection, and trial implementation management. The company works with life science companies to deliver novel therapies quicker and at a lower cost, including all stages of clinical development and a wide range of indications, including rare diseases.

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