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VERO Biotech Announces FDA Approval for Its Second-gen GENOSYL DS

VERO Biotech | February 03, 2023 | Read time : 02:00 min

VERO Biotech Announces

On February 2, 2023, VERO Biotech Inc., a commercial-stage biotechnology company focused on neonatal intensive care and the acute care hospital community, announced that FDA has approved its innovative second-generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use in the operating room with rebreathing anesthesia. The second generation GENOSYL® DS is now the first and only iNO delivery device approved for use in both rebreathing and non-rebreathing anesthesia procedures, enhancing patient care, saving money for the hospital, and minimizing waste anesthetic gas pollution.

GENOSYL® DS is the first tankless inhaled nitric oxide delivery system. Nitric oxide, when inhaled, dilates the pulmonary blood vessels and can improve oxygenation in neonates suffering from hypoxic respiratory failure and pulmonary hypertension. GENOSYL® DS, unlike tank-based systems, generates and delivers iNO at the bedside via a small disposable cassette. This helps eliminate the need for hospitals to manage large, cumbersome tanks while also aiding in the simplification of clinical workflow.

The following are the expected advantages of the second generation GENOSYL® DS

Ability to employ rebreathing anesthesia: Rebreathing allows reduced gas flows, resulting in less usage of expensive anesthetic drugs, thereby reducing hospital costs; enhanced patient comfort (by preserving patient body temperature and moisture).

Smoother care process: seamless iNO delivery from the ICU to surgery and post-operative care leads to process and workflow enhancements for the healthcare organization, thus lowering the hospital's overall cost.

Set and forget: It allows anesthesiologists to continue using rebreathing anesthesia, thereby preventing potentially dangerous, time-consuming and cumbersome workarounds.

Reduced ecological consequences of anesthesia delivery: less anesthetic is released into the environment.

It is important to note that FDA has only approved the second generation GENOSYL® DS for use with rebreathing anesthesia in the surgical suite. The third generation GENOSYL® DS, which was recently approved, has not been tested with rebreathing anesthesia. VERO Biotech is currently conducting similar validations and expects to have data available in the first quarter of 2023.

About VERO Biotech

Headquartered in Atlanta, GA, VERO Biotech is an emerging biotechnology firm that focuses on designing, developing, and commercializing next-generation inhaled nitric oxide (NO) delivery systems to tackle unmet medical needs in patients with cardiopulmonary conditions. The company's mission is to improve patients' lives by pioneering innovative technologies for inhaled NO delivery in acute care hospitals and beyond, wherever nitric oxide treatment is required. By focusing on the science, development, and commercialization of its innovations, it aims to exceed customer expectations regarding safety, efficacy, and growth.

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Semi-automated testing of on-body delivery systems (OBDS)

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POINT Biopharma and AdvanCell to Collaborate in the Development of Lead-212-Labeled Radioligands

Globenewswire | June 27, 2023

POINT Biopharma Global Inc. a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, and AdvanCell, a company developing an innovative pipeline of targeted alpha therapies with a platform technology to produce 212Pb radiopharmaceuticals, today announced a collaboration on the development of a global 212Pb radioisotope and radioligand supply chain and drug manufacturing network to specifically support the clinical development and commercialization of 212Pb-labeled radioligands by each company. 212Pb is differentiated as both an alpha and beta-emitting isotope with a simple decay chain that has demonstrated promising clinical results1 in compassionate use and phase 1 settings. 212Pb is produced via a generator using thorium (228Th, 1.9 year half-life) or radium (224Ra, 3.6 day half-life) sources. 228Th is available in significant quantities and has a half-life that supports 212Pb generators with ~1 year shelf-lives stationed at a selected number of regional locations globally. The short half-life of 212Pb (10.6 hours) has the benefit of delivering >99% of the tumor cell–killing radiation in only 72 hours, which reduces the time that the ligand needs to be retained in the tumor, a common limitation for targeted radioligand therapies. The short half-life may also promote the earlier maintenance of functional immune cells infiltrating the tumor relative to longer-lived isotopes. In contrast, only ~20% of the decays from 225Ac occur in 72 hours, so prolonged tumor retention is required to achieve the same payload delivery. “We constantly strive to use the right isotope for the job, and variations in ligand and tumor characteristics require different isotope properties,” said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. “Adding 212Pb to our toolbox increases the optionality for new programs with the goal of developing new therapeutic options with improved clinical outcomes. Importantly, AdvanCell’s proprietary 212Pb generator technology based on 228Th sources is next-generation technology that we believe can scale to commercial quantities. Having a greater range of isotope choices, combined with supply chain visibility and control over access, will facilitate not only robust clinical development programs but also make eventual supply for commercialization more predictable as we look to expand our pipeline to bring next-generation radioligands to more patients.” “AdvanCell is delighted to collaborate with POINT Biopharma, whose excellence and track record in manufacturing and clinical development we have admired and respected for some time,” said Andrew Adamovich, Chief Executive Officer of AdvanCell. “AdvanCell was founded on the belief that targeted alpha therapies will change the course of cancer treatment. These treatments have demonstrated incredible efficacy but have been hampered by manufacturing and supply issues. AdvanCell’s technology, in combination with POINT’s demonstrated manufacturing expertise and our joint commitment to developing life-saving therapies, will deliver on the promise of targeted alpha therapy and positively impact the lives of many. As AdvanCell progresses ADVC001, our lead clinical program for the treatment of metastatic prostate cancer, this collaboration will accelerate clinical development and ensure the scaled supply of these important medicines.” About POINT Biopharma POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT’s active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment. ‍About AdvanCell AdvanCell is a radiopharmaceutical company developing an innovative pipeline of targeted alpha therapies to improve clinical outcomes in cancer patients. AdvanCell’s Targeted Alpha Therapies are powered by a proprietary platform technology – a novel alpha isotope generator that addresses the greatest unmet need in Targeted Alpha Therapy – the reliable and scalable supply of isotope.

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Cipher Partner, Moberg Pharma Announces Approval for MOB-015 in the European Union

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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PRNewswire | August 17, 2023

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POINT Biopharma and AdvanCell to Collaborate in the Development of Lead-212-Labeled Radioligands

Globenewswire | June 27, 2023

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Cipher Partner, Moberg Pharma Announces Approval for MOB-015 in the European Union

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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Frontage Acquires Nucro-Technics Inc. and Nucro-Technics Holdings, Inc.

PRNewswire | August 17, 2023

Frontage Laboratories, Inc. and its wholly-owned subsidiary, Frontage Canada, Inc., completed the acquisition of Nucro-Technics Inc. and its affiliate Nucro-Technics Holdings, Inc. Nucro-Technics is a pharmaceutical contract research organization that conducts analytical chemistry, microbiology, toxicology, bioanalytical, and stability sample storage and testing services. In addition, it provides consulting services, especially in quality control and assurance as well as in Natural Health Product Regulations. Nucro-Technics, located in the Toronto, Canada metropolitan area, operates in a state-of-the-art 60,000 square foot facility and employs personnel having expertise in testing both large and small molecules designed to treat various medical conditions. For over 50 years, Nucro-Technics has been conducting studies for various clients including major pharmaceutical, biotech, and medical device companies, as well as smaller organizations including industry trade groups and academia. Nucro-Technics has successfully developed and validated numerous methods, as well as participated in providing comprehensive IND packages to clients for regulatory submissions. Nucro-Technics, an ISO 9001:2015 certified organization, conducts studies that are in compliance with GLP and GMP regulations. "Today marks a momentous and an exciting occasion. It is a day to celebrate two great companies coming together. It is with great pleasure that I welcome the extraordinary Nucro-Technics team to the Frontage family," said Dr. Abdul Mutlib, CEO of Frontage. "Nucro-Technics has been recognized as a leader in the Canadian CRO market for over 50 years, and its unparalleled client services is a perfect match for the culture of Frontage Laboratories. This acquisition not only significantly strengthens our presence in Canada, but also will enable the combined organization to offer a more expansive suite of services to clients across the globe. We are looking forward to partnering with the Nucro team to deliver the world-class expertise that clients have come to expect from us." According to Dr. Song Li, Founder and Chairman of Frontage: "Nucro has developed a remarkable platform with a truly impressive team of experts. The closing of this transaction marks the next step in our ongoing effort to build Frontage into one of the major players in the global CRO market. In doing so, we will continue our focus on delivering the highest levels of quality, technology and expertise to our clients." "I'm delighted to announce that we will be partnering with Frontage Labs for the next phase of Nucro Technics' growth journey. Since founding the business in 1970, we've worked hard to become the North American boutique in pre-clinical and drug product release testing services. Partnering with Frontage Labs marks an exciting chapter in the evolution of our efforts to support and accelerate pharmaceutical research and development," said John Fanaras of Nucro Technics. Frontage was advised by Borden Ladner Gervais LLP (BLG) while Nucro-Technics was advised by Dentons and PricewaterhouseCoopers Corporate Finance Inc. About Frontage Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals.  Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions.

Read More

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