US and UK 'lead push against global patent pool for Covid-19 drugs'

The guardian | May 18, 2020

Ministers and officials from every nation will meet via video link on Monday for the annual world health assembly, which is expected to be dominated by efforts to stop rich countries monopolising drugs and future vaccines against Covid-19. As some countries buy up drugs thought to be useful against the coronavirus, causing global shortages, and the Trump administration does deals with vaccine companies to supply America first, there is dismay among public health experts and campaigners who believe it is vital to pull together to end the pandemic. While the US and China face off, the EU has taken the lead. The leaders of Italy, France, Germany and Norway, together with the European commission and council, called earlier this month for any innovative tools, therapeutics or vaccines to be shared equally and fairly.

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Citius Pharmaceuticals, Inc. Secures $3.6 million through New Jersey Economic Development Program

Citius Pharmaceuticals, Inc. | November 22, 2022

Citius Pharmaceuticals, Inc. a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company has been selected to participate in New Jersey's Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss Program, and will receive $3.6 million in non-dilutive capital through the New Jersey Economic Development Authority. Citius expects to receive the funds by late 2022 or early 2023. "This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey's NOL Program. As a pre-revenue business, this program allows us to convert certain losses from operations into tangible working capital today, supporting our ongoing research and development efforts. We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation. This non-dilutive funding will provide added cash runway as we advance a late-Phase 3 trial for Mino-Lok®, a Phase 2b trial for Halo-Lido, and a recently submitted biologics license application for I/ONTAK," Jaime Bartushak, Chief Financial Officer of Citius About the Technology Business Tax Certificate Transfer Program The NOL Program enables participants to sell their New Jersey net operating losses and unused R&D tax credits to unrelated profitable corporations for cash. The NJEDA and the New Jersey Department of Treasury's Division of Taxation jointly administer the NOL Program, which has routinely been hailed as a "lifeline" by entrepreneurs seeking capital for their companies. The average award for companies approved to sell their net operating losses through the program in 2022 was over $3.1 million. Thirty-six percent of program applicants are private businesses, while the remaining 64 percent are publicly traded companies. To date, more than $1.17 billion in funding has been distributed to over 570 technology and life sciences companies since the program's inception in the late 1990s. About the New Jersey Economic Development Authority The New Jersey Economic Development Authority serves as the State's principal agency for driving economic growth. The NJEDA is committed to making New Jersey a national model for inclusive and sustainable economic development by focusing on key strategies to help build strong and dynamic communities, create good jobs for New Jersey residents, and provide pathways to a stronger and fairer economy. Through partnerships with a diverse range of stakeholders, the NJEDA creates and implements initiatives to enhance the economic vitality and quality of life in the State and strengthen New Jersey's long-term economic competitiveness. About Citius Pharmaceuticals, Inc. Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company's diversified pipeline includes two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma for which a BLA has been submitted. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma. In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids.

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BUSINESS INSIGHTS, PHARMA TECH

Koneksa Starts Trial Comparing At-home Mobile Spirometry to In-clinic Spirometry

Koneksa | January 18, 2023

On January 17, 2023, Koneksa, a healthcare technology company that develops evidence-based validated digital biomarkers, announced the beginning of a clinical study that will compare the treatment effect of at-home mobile spirometry using digital biomarkers versus in-clinic spirometry in patients who have moderate asthma and are receiving long-acting beta-agonist (LABA) treatment. The LEARN study is a single-arm interventional trial that compares the identification of treatment effects in people with moderate asthma using at-home mobile spirometry by utilizing an ultrasonic spirometer and a smartphone compared to in-clinic spirometry. Up to 60 people with mild, uncontrolled asthma who already use inhaled corticosteroids (ICS) will take part in the study. Besides, it will also cover those who need to take LABA medication for a six-week treatment period. In-clinic spirometry can be performed at home with the same or higher accuracy compared to in-clinic and potentially less strain on the patient. The study will analyze the LABA treatment impact in clinic and mobile spirometry along with assessing the association between different readouts of mobile spirometry, in addition to evaluating asthma control as determined by the ACQ-6, a patient-reported outcome questionnaire. Other goals include assessing patient and site-specific satisfaction with mobile spirometry technology. Chris Benko, CEO & Founder, Koneksa, stated, “This study builds on Koneksa's prior work demonstrating that mobile spirometry has the potential to detect clinically meaningful changes in very small cohorts of asthma patients on standard of care.” He further added, “The LEARN study will evaluate whether at-home mobile spirometry can detect treatment effects of a known positive control (LABA) in a significantly smaller population than would traditionally be assumed for an in-clinic proof-of-concept study.” (Source – Business Wire) About Koneksa Based out of New York, Koneksa is a patient-centric digital biomarker firm that develops end-to-end solutions for remotely obtained clinical data to expedite clinical research and guide decision-making in drug development and market strategy for the pharmaceutical and biotechnology industries. It seeks to revolutionize effect detection in clinical research by providing integrated solutions for efficient trial designs that yield more meaningful data. Its evidence-based biomarker solutions allow for more efficient clinical trial designs, allowing novel medicines to reach patients sooner.

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BUSINESS INSIGHTS, PHARMA TECH

Epredia and Aiforia Join ReMDO’s RegeneratOR Innovation Accelerator

Epredia | January 19, 2023

On January 18, 2023, PHC Group, a healthcare company renowned in diagnostics and life sciences, announced that it would join the RegeneratOR Innovation Accelerator to grow its presence in regenerative medicine. The Wake Forest Institute for Regenerative Medicine (WFIRM) and the RegenMed Development Organization (ReMDO) are the two institutions expediting the discovery and translation of regenerative medicine therapeutics located in the Innovation Quarter. PHC Group, being an early partner of ReMDO's RegeneratOR Test Bed, offered advanced tissue processing technologies as well as support to researchers for prototype and product development. In addition, another ReMDO program, the Innovation Accelerator, was formed to give space and support to companies with innovative or emerging regenerative medicine technologies. PHC Group is now opening a local office within the Innovation Accelerator. Its holding companies and partners include Epredia, a precision cancer diagnostics company whose products are used by researchers and pathologists worldwide, and Aiforia, a medical software company that develops artificial intelligence software for image analysis in pathology. Aiforia's collection of preclinical and clinical pathology instruments is distributed globally by Epredia. The firms work together to deliver slide imaging and AI-based solutions that enable researchers to investigate and extract information beyond the scope of human visual perception. Thus, clinical research, drug discovery, and translational studies with the goal of better understanding disease states are all linked together through diagnostic microscopic imaging and artificial intelligence. PHC Group's presence, along with Epredia and Aiforia's superior technology assistance at the Innovation Accelerator, will also pave the path for RegeneratOR's newest initiative, the RegenMed Clinical Trials Catalyst. As a part of Wake Forest University School of Medicine and the academic core of the newly merged Advocate Aurora Health and Atrium Health, the Catalyst will have access to 5.5 million patients, serving 67 hospitals in North Carolina, Wisconsin, South Carolina, Georgia, Alabama, and Illinois. About Epredia Epredia is a leading comprehensive laboratory solutions provider for instruments and consumables in anatomic pathology, histology, and cytology. It was established through an acquisition by PHC Group from Thermo Fisher Scientific. The company provides solutions for cancer diagnostics through its renowned brands: Richard Allen Scientific, Erie Scientific, Microm, Shandon, and Menzel-Glaser. Epredia is committed to realizing its aim of advancing cancer diagnostics for patients worldwide in order to save lives.

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