Spotlight

Shortages of medicinal products are an increasingly problem globally. Although there are many causes of shortages – issues of manufacturing, supply, quality and commercial viability – the consequences are inevitably on patients. This theme examines ways to address this problem. It will set out why preventing drug shortages needs to be a priority and explores the steps that regulators can take to protect patients. How do we encourage the broad cooperation between regulatory authorities inside and outside Europe that can help reduce shortages and limit their impact when they do occur.

Related News

RESEARCH

Pluristem Enters Collaboration With Pharmaceutical Company Innovare R&D to Expand Pluristem’s ARDS Associated With COVID-19 Program to Mexico

Pluristem | December 30, 2020

Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a main regenerative medication organization building up a foundation of novel natural helpful items, reported today it has gone into a coordinated effort concurrence with Mexican drug organization Innovare R&D to extend its continuous clinical program of PLX cells in the treatment of Acute Respiratory Distress Syndrome (ARDS) related with COVID-19 in Mexico. The Phase II investigation in Mexico is dependent upon the endorsement of neighborhood specialists, with the objective of being led under the U.S. Food and Drug Administration (FDA) cleared convention. As per the arrangement, Innovare will open clinical destinations and enlist patients for the proposed clinical investigation in Mexico. Innovare will subsidize the examination in Mexico and will buy PLX cells for the investigation from Pluristem. Subject to potential positive clinical investigation results and Mexican administrative endorsement for commercialization, the arrangement awards Innovare restrictive conveyance rights in Mexico to supply PLX cells for treating serious COVID-19 cases confounded by ARDS. All protected innovation and assembling rights stay with Pluristem. With 1,389,430 cases and 122,855 passings as of December 29, 2020, Mexico's COVID-19 disease and death rates have been expanding. Mexico has the most elevated passings relatively to COVID-19 cases or populace on the planet as of December 28, 2020, as announced by Johns Hopkins University of Medicine. "We are satisfied to unite with Innovare, a main imaginative organization intending to be important for the answer for battling the COVID-19 pandemic in Mexico," expressed Pluristem CEO and President, Yaky Yanay. "On account of our key upper hand of having in-house producing office, progressed strategic capacities, and a worldwide reach, we can supply PLX cells to clinical bases on the world while broadening our worldwide help for COVID-19 into Latin America. By directing the examination in both the U.S. furthermore, Mexico, in corresponding to the E.U. furthermore, Israel, we are proceeding with our attention on accomplishing clinical achievements and targets, while bringing the expected treatment of PLX cells to those out of luck." Gerardo Cárdenas Vogel, CEO of Innovare R&D remarked, "As an organization that is looking for overall accomplices indicating clinical guarantee for neglected clinical necessities, we are eager to team up with Pluristem. We anticipate utilizing our clinical and business capacities with Pluristem's high level cell treatment answer for help create and possibly bring a genuinely necessary treatment for ARDS patients related with COVID-19 to Mexico."

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BUSINESS INSIGHTS

COEUS Holdings Announces Partnership With Insight Consulting Group (ICG) to Address the Healthcare Industry’s Changing Research and Insight Landscape

COEUS Holdings | September 18, 2021

COEUS Holdings, LLC, and its subsidiaries, together a leading boutique life sciences technology and consulting firm, today announced that it has entered a partnership with Insight Consulting Group (ICG). The partnership seeks to bridge the gaps between payers, healthcare providers, and consumers by developing insights and strategies that are reflective of today’s integrated needs. The partnership will produce and apply comprehensive insights to inform strategy that could advance access to more medications and help to address the unmet needs of Physicians and Patients. While ICG’s expertise, proprietary processes, and deliverables will be leveraged by various organizations that are part of COEUS Holdings’ group of subsidiaries, Mirador Global, led Chuck Peipher, Managing Partner, will be most regularly engaged. Mirador delivers consulting expertise in early commercial development for global and domestic drug commercialization and market access efforts. This partnership takes direct aim at the delivery of game-changing insights and market research that will take shape in a variety of touchpoints through the commercial development process. Together, we’ll be able to work more quickly and effectively through this partnership given the common knowledge of the social sciences, brand development processes, and a commitment to our clients who are focused on serving the needs of Physicians and Patients. - Chris Schnaars, Principal at Insight Consulting Group. Ultimately, all stakeholders in the healthcare ecosystem (patients, caregivers, HCPs, influencers, extenders, payers, and provider organizations) must work together to create an optimal care environment. Through shared resources that deliver deeper research and insights, the ICG and COEUS partnership will facilitate a more comprehensive and robust understanding of how healthcare clients can meet the needs and achieve ideal outcomes for all stakeholders. The ICG and COEUS partnership will enable clients to realize the benefits of working with one team, with end-to-end research and payer capabilities. It’s the combination of insights being leveraged simultaneously during the design and development of marketing and payer strategies that will deliver incremental value to the industry. About ICG ICG inspires deeper healthcare understanding by bringing its clients’ most important interactions into research. Understanding human needs and translating them into behavioral insights is at the forefront of the design of our deliverables. ICG brings high proficiency and experience to analysis of insights, raising the bar of confident decision making and commercial impact. ICG is focused on meeting people where they are (not where we want them to be) and understanding what true core human and emotional needs can be addressed to influence behavior and impact outcomes. About Mirador Global LP Founded in 2016, Mirador Global LP is an international consulting practice that specializes in strategic global commercial development for specialty diseases, including rare diseases, oncology/​immuno-oncology, immunology, and CNS disorders. Mirador Global client engagements are developed bringing together Global Marketing, Analytics, Market Access, HEOR, Medical Affairs, R&D, and other functions delivered by a team of pharmaceutical industry experts. The company provides its clients with a bio-pharma line of sight unlike any other unique to Mirador Global. About COEUS Holdings The COEUS Holdings teams are singularly driven to optimize market access and commercialization infrastructure for pharmaceutical products. COEUS is a multi-specialty, commercially aligned consultancy, offering a comprehensive suite of informed solutions for successful engagement with organized customers, providers, and patients. Leveraging years of collective real-world market expertise, we offer unique perspectives into clinical and business opportunities to support your brands’ position in the marketplace. COEUS mission is to ensure patient access beyond the prescription. We focus on becoming your ally in navigating the healthcare universe. COEUS teams advance thought leadership, technology solutions, and communication initiatives to ensure your brands’ lifelong success. Together, we strive to redefine access solutions in the evolving domestic and global managed care markets.

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PHARMACY MARKET

Tarsier Pharma Raises Capital to Execute Phase-3 Clinical Trial

Tarsier Pharma | August 28, 2021

Tarsier Pharma, a late clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients with blinding ocular diseases, today announced it raised capital to execute a phase-3 clinical trial of its TRS01 program in the US and Europe. Strategic and new investors alongside existing investors participated in this transaction. Following a successful End of Phase II meeting with the FDA, the Company obtained all necessary regulatory approvals to execute phase 3 and has recruited leading uveitis experts as principal investigators. Tarsier plans to enroll the first patient in Q4 of 2021. Tarsier's technology, TRS, is a novel immunomodulator molecule that showed, in a dose-ranging, randomized, double-masked phase I\II trial in the target indication, a prompt and statistically significant improvement in signs and symptoms of uveitis. "We are excited to have the support of our existing and new investors, as we continue our clinical development of TRS01 in advanced stages," said Dr. Haim Langford, CEO of Tarsier. "Looking ahead, we are eager to bring our lead product to market and simultaneously progress our development of important pipeline projects for other back-of -the-eye blinding diseases, and plan to raise additional capital to realize these as well." About Tarsier Pharma Tarsier Pharma is a late clinical stage pharmaceutical company, phase-3 ready, focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular blinding diseases. TRS is a breakthrough proprietary technology platform, based on a new bio-inspired chemical entity, with novel mechanism of action and demonstrated safety and efficacy in a rare debilitating and blinding indication. Lead product candidate for uveitic glaucoma Non-infectious uveitis is an autoimmune blinding ocular inflammation, considered the third leading cause of blindness in the developed world. Tarsier's TRS01 is a potent fast-acting immunomodulator, delivered as eye drops, for the treatment of non-infectious anterior uveitis in patients with uveitic glaucoma – considered an end-stage condition of uveitis. Once a uveitis patient has also developed glaucoma (uveitic glaucoma), the only available treatments for active inflammation, which are steroids, should be avoided, due to their negative side effects in expediting glaucoma and vision loss. Thus, TRS01 has the potential to become the standard of care for uveitic glaucoma.

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Spotlight

Shortages of medicinal products are an increasingly problem globally. Although there are many causes of shortages – issues of manufacturing, supply, quality and commercial viability – the consequences are inevitably on patients. This theme examines ways to address this problem. It will set out why preventing drug shortages needs to be a priority and explores the steps that regulators can take to protect patients. How do we encourage the broad cooperation between regulatory authorities inside and outside Europe that can help reduce shortages and limit their impact when they do occur.