One whole-body MRI could replace multiple cancer scans

pharmatimes | May 14, 2019

The National Institute for Health Research has announced that doctors could potentially use just one scan to assess the spread of a patient’s cancer instead of the current practice of multiple scans. Two studies published in Lancet Respiratory Medicine and Lancet Gastroenterology and Hepatology show that for patients with non-small cell lung cancer (NSCLC) and colorectal cancer, one whole-body MRI (WB-MRI) scan can work just as well as multiple scans, offering a quicker, cheaper alternative, preferred by patients and involving less exposure to radiation. The average cost of a WB-MRI scan for NSCLC patients was £317, half the £620 cost for multiple scans and the cost of a WB-MRI scan for colorectal patients was £216, compared with £285 for multiple scans.

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How medicine is Prepared in the factory. And there separate testing & storage.

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How medicine is Prepared in the factory. And there separate testing & storage.

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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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BUSINESS INSIGHTS

Actinium Pharmaceuticals, Inc. And Immedica Have Signed a Commercialization Agreement for Iomab-b (131i Apamistamab)Apamistamab)

Actinium Pharmaceuticals, Inc. | April 13, 2022

Actinium Pharmaceuticals, Inc., a leader developing targeted radiotherapies for patients and Immedica Pharma AB announced that they signed a license and supply agreement for Iomab-B. It is being developed for targeted conditioning to facilitate bone marrow with topline data expected in the third quarter of 2022. For individuals with active, relapsed, or refractory acute myeloid leukemia, BMT is the only possibly curative therapy option. "Immedica has established a strong team and impressive capabilities to commercialize specialty products in Europe, the Middle East and North Africa. Europe and the MENA countries are key commercial markets for Iomab-B, with a large addressable AML patient population and access to a strong BMT community that is highly concentrated with select leading centers performing a majority of the BMT procedures. Despite multiple drug approvals for patients with AML in recent years, curative outcomes and access to potentially curative BMT are severely lacking, particularly for patients with active, relapsed or refractory disease. We are excited to partner with Immedica to work to bring Iomab-B to patients with AML in Europe, the Middle East and North Africa who may benefit from a potentially curative transplant." Sandesh Seth, Actinium's Chairman and CEO "We are excited about the opportunity to make Iomab-B accessible for patients in Europe, the Middle East and North Africa. It is clear there is a large medical need for these AML patients, which we believe will be addressed by this new innovative treatment. We also look forward to deepening our collaboration with Actinium to bring the best possible support to AML treatment centers and health care professionals in Europe, the Middle East and North Africa", says Anders Edvell, CEO at Immedica. Actinium will receive a $35 million upfront payment and will be eligible for an additional $417 million in regulatory and marketable milestone payments and royalties in the mid-twenty percent range on net sales, per the terms of the agreement. Immedica has been granted commercialization rights in Europe and, the Middle East and North Africa (MENA). Actinium will maintain all rights to Iomab-B in the United States and around the world and will be accountable for clinical and regulatory operations, as well as Iomab-B manufacturing.

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POLICY AND REGULATION

EpiEndo Pharmaceuticals Secures Funding to Advance Clinical Development of its Non-Antibiotic Macrolide for the treatment of COPD

EpiEndo Pharmaceuticals | August 19, 2021

EpiEndo Pharmaceuticals , a privately held biopharmaceutical company focused on a novel barrier enhancing approach to the treatment of chronic inflammatory airway diseases such as chronic obstructive pulmonary disease (COPD), announces the closing of a €20m Series A financing round led by Flerie Invest and Iðunn Venture Fund, with existing investors ABC Ventures participating, along with the European Innovation Council (EIC) Fund joining the round. The financing secures funds to advance clinical development of EpiEndo’s lead compound EP395, which entered phase I clinical trials in April, through Phase IIa, targeting COPD as a primary indication. EpiEndo’s development rationale is based on a newly acknowledged therapeutic paradigm, that loss of integrity of epithelial barriers plays a critical role in propagating chronic inflammatory diseases in lungs and contributes to vulnerability to infections associated with acute exacerbations of airway diseases. “I am delighted to announce the closing of this new investment round,” commented Maria Bech, CEO of EpiEndo Pharma. “We are very pleased to welcome such well-reputed investors as Flerie Invest and Iðunn Venture Fund to help us build our company and are honoured that the European Innovation Council Fund has chosen EpiEndo as its first follow-on investment. We are also grateful for the continued support of our existing investors. This financing is a major step for EpiEndo, not only funding our lead compound through clinical development in patients with COPD, but also enabling exploration of other important potential therapeutic application areas such as dermatology and gastrointestinal disorders, where compromised epithelial integrity is known to contribute to disease pathophysiology.” Macrolide antibiotics such as azithromycin have been known for decades to exhibit good disease modifying efficacy against many chronic inflammatory airway diseases in addition to their antibacterial properties, in which their long-term use reduces the frequency and severity of inflammatory flare-ups and exacerbations. Although beneficial for overall health and prognosis, their off-label use in these patient populations has led to the emergence of macrolide resistance in the host flora. EpiEndo’s lead compound EP395 is a new chemical entity in which the epithelial regenerative properties and anti-inflammatory effects seen with macrolides have been augmented, and the anti-bacterial properties removed. Using this Series, A funding, EpiEndo aims to advance the clinical development of EP395 towards approval as the first disease modifying non-antibiotic macrolide that can be prescribed safely and effectively as a long-term treatment for patients with COPD. “We have followed EpiEndo for some time and have seen impressive progress towards clinical phase of their lead compound EP 395. We are proud to take part in their continuing journey with the aim to deliver substantially improved treatment of COPD,” said Carl-Johan Spak, Senior Advisor at Flerie Invest. “EpiEndo is an attractive investment opportunity for Iðunn and a good fit for our fund’s investment strategy. We are looking forward to work with the company in the coming years to develop its lead candidate through the coming clinical phases. It is important for Iðunn to participate in the translation of new scientific discovery into clinical practice,” commented Hilmar Bragi Janusson, Managing Director of Iðunn Venture Fund. “ABC is thrilled to obtain, in this round, a group of new investors to co-lead with us and support EpiEndo´s quest to create a solution to some of the most problematic diseases,” commented Ivar Gudjonsson, Managing Director of ABC Venture and a board member of EpiEndo. “EpiEndo Pharmaceuticals’ challenge is to develop a new class of drugs and we are delighted to take part in this scale up journey,” said José Fernando Figueiredo, EIC Fund Investment Committee member, “The EIC Fund is taking part in this financial round to help this great example of a life science company to develop and deploy breakthrough treatment of chronic obstructive inflammatory pulmonary disease.” About EpiEndo Pharmaceuticals EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders that focuses on enhancement of epithelial barrier integrity as a critical pathophysiological factor underlying the etiology of a number of major diseases. Epithelial cells are a key component of the barrier that makes up human lung tissue and other organs such as the gut and skin. Compromised integrity of this barrier is implicated in the progression and non-resolution of several chronic inflammatory diseases. EpiEndo is developing a proprietary portfolio of orally available macrolide drugs with promise as first-in-class disease-modifying therapeutics, to address the huge global burden of chronic diseases of the lung and other organs where there is other significant unmet medical need. EpiEndo’s lead drug candidate, EP395, aims to be the first on-market oral, non-antibiotic, barrier strengthening and anti-inflammatory macrolide for the treatment of COPD.

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