Review of impact of drug holidays on bone health

Medicalxpress | July 08, 2019

The impact of interruption of anti-osteoporosis treatment in patients on therapy with bisphosphonates or denosumab is reviewed in a new International Osteoporosis Foundation (IOF) working group paper 'Fracture risk following intermission of osteoporosis therapy' published in the journal Osteoporosis International. The widespread practice of recommending one to two year 'drug holidays' arose following concerns that long-term use of bisphosphonates is associated with rare side effects, namely atypical femoral fractures and osteonecrosis of the jaw. However, available evidence suggests that for patients who are at high risk of fracture the risk-benefit ratio is clearly in favour of treatment continuation, with approximately 100 new fragility fractures prevented for each of these adverse events. Lead author, Prof. Elaine Dennison, of the MRC Lifecourse Epidemiology Unit, University of Southampton, UK, stated: "Our aim was to review the available literature to assess what evidence exists to inform decision making on drug holidays and to identify any indicators that might help clinicians decide whether to continue or discontinue therapy in individual patients."

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The spreadsheet conundrum... Joe Smith, sales director for Great Start-Up Number 5 Billion and Thirty-One, puts on a blindfold and reaches out blindly for something, ANYTHING, to help him organize his team’s deals and commissions. He’s hopeful. He’s waiting. He knows he’ll come back with something. We’re talking metaphorically, of course. He’s not actually HOLDING a spreadsheet, he’s using Excel—because it’s the lowest hanging fruit. It’s free and easy to learn. And for a while, you know what? It works great. He can use VLOOKUPS and shortcuts to navigate. He can import booking results and activity metrics from Salesforce or his CRM. He can get so good at it that packaging complex algorithms becomes second nature.


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BUSINESS INSIGHTS

Breckenridge Signs New-Product Agreement with PTS Pharma

Breckenridge Pharmaceutical, Inc. | April 23, 2022

Breckenridge Pharmaceutical, Inc. announces today that it has signed a new-product agreement with PTS Pharma, LLC. under which PTS will support a technology transfer to Towa Pharmaceutical Europe, S.L. of a complex "For Suspension" product developed by PTS. The remainder of development and commercialization will be performed at the Towa facility. According to industry sales data, the product and its generics had annual sales of approximately $75 million during the twelve months ending February 2022. The companies are actively negotiating and look forward to collaborating on additional complex formulations under the same business model. About Breckenridge Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical, partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve. About PTS Pharma, LLC PTS Consulting, LLC and PTS Pharma LLC., is a formulation development, clinical trial production, regulatory services and analytical control laboratory based in Kansas. PTS Consulting is actively involved in regulatory consulting services. PTS Pharma operations include the capability and expertise to develop complex formulations of tablets, capsules, granules, modified dosage forms, topical dosage forms, suppositories, film products, solution, and suspension formulations and sterile injectables, with involvement in multiple aNDA and NDA filings over the years. The activities are housed in dedicated GMP suites in the facility in Kansas City, USA. PTS Pharma is also involved in active raw material clinical production by fermentation technology processes. The firm was founded in 2003 by Paul Sudhakar, an industry veteran who is the Owner, President, and CEO of the firm.

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BUSINESS INSIGHTS

Omnicell Completes Acquisition of ReCept

Omnicell, Inc. | December 30, 2021

Omnicell, Inc. a leading provider of medication management solutions and adherence tools for health systems and pharmacies, has completed the previously announced acquisition of ReCept Holdings, Inc. The addition of ReCept’s specialty pharmacy management services for health systems, provider groups, and federally qualified health centers expands Omnicell’s Advanced Services portfolio to address the growing and complex specialty pharmacy market. ReCept provides implementation and managed services for health systems and other provider organizations to optimize their specialty pharmacy programs and the related pharmaceutical aspects of patient care. This total solution supports on-site management, including payor contracting, staffing, licensing, quality assurance, 340B administration, and preferred pricing agreements designed to improve margin and profitability, while keeping the patient at the center of care. “ReCept’s specialty pharmacy management services capabilities naturally complement Omnicell’s intelligent infrastructure, giving us deeper expertise to address the growing market need for managing complex specialty medications as part of a broader, more comprehensive medication management strategy,” Randall Lipps, chairman, president, CEO, and founder of Omnicell Under the terms of the purchase agreement, the acquisition price was $100 million, subject to customary adjustments, as provided for in the agreement and plan of merger. The ReCept business that is being acquired recorded annual recurring revenue of $24 million (unaudited) for the 12 months ended September 30, 2021, and is expected to accelerate Omnicell’s Advanced Services revenue growth. Omnicell used cash on its balance sheet to fund the transaction, which is expected to be accretive to Omnicell’s non-GAAP EBITDA beginning in the first quarter of 2023. About Omnicell Since 1992, Omnicell has been committed to transforming the pharmacy care delivery model to dramatically improve outcomes and lower costs. Through the vision of the autonomous pharmacy, a combination of automation, intelligence, and technology-enabled services, powered by a cloud data platform, Omnicell supports more efficient ways to manage medications across all care settings. Over 7,000 facilities worldwide use Omnicell automation and analytics solutions to help increase operational efficiency, reduce medication errors, deliver actionable intelligence, and improve patient safety. More than 60,000 institutional and retail pharmacies across North America and the United Kingdom leverage Omnicell's innovative medication adherence and population health solutions to improve patient engagement and adherence to prescriptions, helping to reduce costly hospital readmissions.

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PHARMACY MARKET

Veneno Technologies, a Novel DRP Drug Discovery Company, Raises $2Million (¥200M Yen) in Seed Funding Round

Veneno Technologies Co. Ltd. | January 27, 2022

Veneno Technologies Co. Ltd. is pleased to announce that it has completed fundraising of 200 million yen through a third-party allocation of new shares to SBI Investment Co., Ltd., Tsukuba Institute of Research, Ltd., and SBI regional activation support Co., Ltd. The funds raised will be used to strengthen the recruitment and organizational structure, to further develop the Company's proprietary peptide drug discovery platform technology, and invest in the research and development of the Company's own drug discovery pipeline using DRP functional peptides as basic molecules to further promote DRP drug discovery. Objective of the Fund Procurement Veneno Suite™ is the Company's proprietary integrated DRP drug discovery technology. The Veneno Suite™ consists of a large gene library that is created by artificially accelerating the evolution of natural DRPs using them as templates, a screening system that enables the search for target DRPs from the library in a fast and efficient manner, and technology that enables the efficient production of various DRPs in a short period of time. With this funding, we will further refine these technologies and accelerate DRP drug discovery. Our mission is to contribute to the advancement of medicine by providing new drugs for targets such as membrane proteins that have been difficult to discover, and for intractable diseases related to these targets. In order to fulfill this mission, we will strengthen the following points through this fundraising. Appointment of high-level researchers and opening of new laboratories to advance DRP drug discovery. Expansion of the DRP focused library (DRP Space™). Strengthen and expand the pipeline of the DRP rapid search system (PERISS™) (promote joint research). Development of DRP manufacturing technology (Super Secrete™) including establishment of high-efficiency, low-volume, high-mix manufacturing technology. This funding will enable us to further refine our proprietary large-scale library, high-speed screening technology, and high-efficiency DRP manufacturing technology to accelerate our goal of DRP drug discovery. We expect that we will be able to take a concrete step toward the establishment of a new paradigm using DRP as a new drug discovery platform molecule following antibody drugs. Investor Comments Mr. Makoto Hasegawa, Manager, Investment Division, SBI Investment Co. noted, "Veneno Technologies has developed an innovative technology to turn functional peptides, called DRPs, into pharmaceuticals. We have decided to invest in Veneno Technologies because we see the potential in their technology and want to take on the challenge of developing new modalities together. We hope that our technology will lead to the development of many innovative new drugs in the future." "Veneno Technologies is a drug discovery venture that uses this technology to develop drugs that target ion channels, which remain untapped as drug targets." Mr. Masato Suzuki, Senior Researcher, Consulting Department, Tsukuba Research Institute, Inc About Veneno Technologies, Inc. Veneno Technologies was established to accelerate the research and development of DRP functional peptides and to contribute to advanced and sustainable medicine and society. The company was established to accelerate the research and development of DRP functional peptides and to contribute to advanced and sustainable medicine and society. By integrating innovative DRP discovery technologies that have been researched for many years at the National Institute of Advanced Industrial Science and Technology (AIST) and DRP manufacturing technologies that are currently being researched and developed, we will lead the research and development of various DRP drug discovery technologies such as new drugs, research reagents, agrochemicals and biostimulants.

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BUSINESS INSIGHTS

Integrity Bio and LakePharma Become Curia

Curia | February 15, 2022

Curia, formerly AMRI, a leading contract research, development and manufacturing organization, announced that Integrity Bio and LakePharma, two companies that it acquired last year, have fully transitioned to the Curia brand. This change reflects the accelerated organizational integration of the acquired companies into Curia and its provision of comprehensive biologics discovery, development and manufacturing solutions to customers. Curia completed the acquisition of Integrity Bio in August 2021 and closed the LakePharma transaction in September 2021. “The addition of LakePharma and Integrity Bio demonstrate our commitment to expanding and deepening our biologics capabilities. We have moved quickly to integrate our expanded organization so we can provide comprehensive technology and scientific solutions that enable customers to advance their biologics candidates from R&D through manufacturing. More than a name change, the combined Curia organization brings a singular focus on creating a distinctive customer experience designed to accelerate projects and navigate complexity, all driven by a shared commitment to the mission of improving patients’ lives." Curia Chairman and CEO John Ratliff About Curia Curia, formerly AMRI, is a leading contract research, development and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s 3,700 employees at 29 locations across the U.S., Europe and Asia help its customers advance from curiosity to cure.

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Spotlight

The spreadsheet conundrum... Joe Smith, sales director for Great Start-Up Number 5 Billion and Thirty-One, puts on a blindfold and reaches out blindly for something, ANYTHING, to help him organize his team’s deals and commissions. He’s hopeful. He’s waiting. He knows he’ll come back with something. We’re talking metaphorically, of course. He’s not actually HOLDING a spreadsheet, he’s using Excel—because it’s the lowest hanging fruit. It’s free and easy to learn. And for a while, you know what? It works great. He can use VLOOKUPS and shortcuts to navigate. He can import booking results and activity metrics from Salesforce or his CRM. He can get so good at it that packaging complex algorithms becomes second nature.

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