Pharmacy Market
PRNewswire | July 11, 2023
Signant Health, the leader in evidence generation for modern clinical trials, announced expanded flexibility and capabilities for its leading Signant SmartSignals Supplies software, empowering small and mid-size customers to experience the advantages of technology-driven clinical supply management.
Relaunched as Signant SmartSignals Supplies GxP Inventory, the solution provides sponsors and contract research organizations (CROs) with efficient, comprehensive management and oversight of the end-to-end supply chain. Unlike spreadsheet-based supply chain management, the GxP Inventory solution offers centralized, full visibility of clinical trial material creation, release, and distribution activities within a single system. Available as either an Essential or Enterprise option, clinical research sponsors can select the optimal solution for their needs, which is often dictated by size or trial volume.
The Essential option enables sponsors to deploy quickly using our pre-configured system for inventory manufacturing, management, and QA/QP release. The Enterprise option provides more advanced features for larger customers with internal supply chain capabilities to meet more individualized requirements, sponsor-specific terminology/labels, and additional workflow/process options. Both options are SaaS-based for cost-effective implementation, reduction of internal technology investments, and ease of ongoing maintenance.
"Signant is extremely proud of its heritage as a leading provider of GxP inventory management solutions to many top-20 sponsor organizations. Our Essential option now extends the same benefits to smaller sponsors and CROs who wish to have the same level of inventory control, regulatory compliance, and visibility in a more compact, per-protocol commercial offering," said Sanjiv Waghmare, Signant's chief product officer.
Technology-based solutions make clinical trials safer for patients through better visibility and control of supplies, particularly with respect to investigational products. From sourcing drug substance ingredients to randomized patient kits, these solutions ensure that all supply chain data is in one place, and not distributed across spreadsheets, emails, and external inventory management systems. With the launch of the Essential option, we are making the technology-based solution for clinical supply management accessible to sponsors of all sizes.
About Signant Health
Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics.
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Pharmacy Market
prnewswire | August 29, 2023
Halozyme Therapeutics, Inc. announced the approval of Roche's Tecentriq® SC (atezolizumab), using Halozyme's ENHANZE® drug delivery technology, by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. Tecentriq® subcutaneous (SC) is co-formulated with Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, allowing for subcutaneous delivery, which takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq® SC will be available to patients in Great Britain for certain types of lung, bladder, breast, and liver cancer.7
Multiple oncology studies suggest that most cancer patients prefer to receive their treatments via subcutaneous delivery, instead of intravenous infusion because of reduced discomfort, ease of administration, and shorter duration of treatment.2,4,11
"We are delighted that Roche has received approval of Tecentriq SC in Great Britain. Subcutaneous delivery of Tecentriq provides cancer patients a faster and more flexible treatment option and may alleviate pressure on healthcare system resources," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to additional regulatory approvals of our partner products utilizing ENHANZE."
Tecentriq® SC is the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain and is Roche's fourth subcutaneous cancer therapy using Halozyme's ENHANZE® drug delivery technology.8-10 The approval is based on clinical data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq® in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.12 While the IMscin001 trial was conducted within the hospital setting, the SC formulation may be suitable for out-of-hospital administration by a healthcare professional.
The U.S. Food and Drug Administration (FDA) is currently evaluating Tecentriq® SC for regulatory approval.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 patient lives in post-marketing use in six commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.
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Research
Newswire | July 05, 2023
Cipher Pharmaceuticals Inc. ("Cipher" or "the Company") today announced that the Company's partner, Moberg Pharma AB, ("Moberg Pharma") has obtained European Union approval for MOB-015 (nail fungus treatment) as a result of demonstrating superior levels of mycological cure (76% vs. 42% for comparators) and a significantly better complete cure rate.
MOB-015 has been recommended for national approval in 13 European countries, which will be commercialized through partners such as Bayer and Allderma, and is expected to be launched in Nordic countries such as Sweden during 2023.
Cipher holds the exclusive Canadian rights to MOB-015, a new topical treatment of Onychomycosis (nail fungus) based on Moberg's patented proprietary formulation of terbinafine. In Canada, according to IQVIA, the total prescription market for Onychomycosis was greater than $82 million CDN at December 31, 2022 with a single product having over 90% market share.
Craig Mull, Interim CEO of Cipher commented, "This is a fantastic achievement whereby the European Union has recognised MOB-015 as delivering quick visible improvements to patients living with nail fungus. We are excited about our partnership with Moberg Pharma, who have a strong track record developing and commercializing nail fungus products previously in both Europe and North America. This approval is a tremendous step in the right direction towards ultimately receiving market approval in Canada and the United States. We will continue to work closely with Moberg in making this clinically proven effective treatment available to Canadians as soon as possible."
Moberg Pharma continues to invest and advance MOB-015 through an additional phase 3 trial of a total of 350 patients with sites across the United States and Canada. The purpose of this study is to facilitate market approval in North America as well as further strengthen the product's clinical evidence beyond the mycological and complete cure rates already demonstrated to the European Union. Patient enrollment in the clinical trial is progressing according to plan with full enrollment expected in 2023.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticalsis a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America.
About Moberg Pharma
Moberg Pharma AB is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's main asset, MOB-015, is a novel topical treatment for onychomycosis. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in Europe and Japan, among others, and the company's goal is to receive its first market approval and launch MOB-015 in 2023.
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