Parallel's Surterra Wellness Stores to Introduce New Products Including Edibles in Florida

Prnewswire | August 31, 2020

Parallel, formerly known nationally as Surterra Holdings, a company pioneering well-being through its proprietary cannabinoid brands, science and technology-led innovation, today announced that it will introduce new edible cannabis products to its customers in its 39 Florida Surterra Wellness stores. This expansion of Surterra Wellness' product offering follows the Florida Department of Health's (FDOH) finalizing recently released emergency rules to allow for the production and sale of edible products. Launch is dependent on regulatory approval of each of those products. Surterra Wellness, widely known for its line of whole flower, vaporizers, tincture oils, topical patches, theragels and lotions, is Parallel's leading cannabis retail brand for patients and customers aiming to improve their well-being in both Florida and Texas.

Spotlight

There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. For primary pack choices, there are traditional vials, ampoules, cartridges, pre-filled syringes and complex containers such as the various types of dual chamber syringes. Additionally, there are newer dosage forms such as wearable injection devices or pump patches. Each has its own merits and advantages, but these advantages may not be realized until the product is marketed.

Spotlight

There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. For primary pack choices, there are traditional vials, ampoules, cartridges, pre-filled syringes and complex containers such as the various types of dual chamber syringes. Additionally, there are newer dosage forms such as wearable injection devices or pump patches. Each has its own merits and advantages, but these advantages may not be realized until the product is marketed.

Related News

BUSINESS INSIGHTS

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.

Read More

PHARMA TECH

Alimentiv, Satisfai Health, and Virgo Announce Partnership to use AI-driven technology to Enhance Clinical Trials in IBD and other GI Diseases

Alimentiv Inc. | October 06, 2022

Alimentiv Inc. Satisfai Health, Inc and Virgo Surgical Video Solutions, Inc. announced a strategic partnership to revolutionize central reading, data capture, decision support, and patient recruitment in the clinical trial domain for Inflammatory Bowel Disease and allied GI conditions. Satisfai, a global leader in developing artificial intelligence solutions for gastroenterology, and Virgo, an industry leader in endoscopy video capture technology, will leverage their combined strengths to work in partnership with Alimentiv, a leading CRO in gastroenterology, to realize the full potential of AI-powered precision imaging in the GI clinical trials space. "This synergy of Satisfai and Virgo with Alimentiv is a positive development for patients with IBD and the drug development space. Clinical trials have many pain points, and this strategic partnership will enable advances in improving the efficiency of clinical trials and make some significant changes to how trials are run. We are delighted to enter this arrangement to bring the next generation of imaging technology to clinical trials in gastroenterology." Jeff Smith, CEO of Alimentiv "Artificial Intelligence in medicine is being increasingly adopted across various clinical specialties, with gastroenterology being one key field of use, particularly endoscopy," said Dr. Michael Byrne, CEO and founder of Satisfai Health, Clinical Professor of Medicine and gastroenterologist in Vancouver. "Working with Virgo, we are excited to bring AI-driven solutions to the IBD clinical trials arena. To be able to do so with Alimentiv — a leading Gastroenterology and imaging CRO—is a great opportunity. Our clear ambition is to change the clinical trial paradigm for IBD and other disease states such as Eosinophilic Esophagitis. As three groups working together, we are confident we can do so." "Combining Satisfai's marquis AI solutions with Virgo's HIPAA and SOC 2 compliant automated cloud video capture technology and Alimentiv's 21CFR11 compliant solutions, expansive site community, and imaging expertise is very powerful. We truly look forward to realizing this vision and bringing real-time, in-line AI solutions to GI clinical trials worldwide," said Matthew Schwartz, CEO and co-founder at Virgo. This partnership will facilitate Alimentiv's continued leadership in GI Clinical Trials through exclusive access to Satisfai's SmartScore Central Reading tool and Virgo's fully integrated, hands-free, cloud-based high-definition video-capture fleet. In addition, this will provide pharmaceutical and biotech sponsors with access to the ongoing development of novel endpoints, scoring methodologies, and scalable solutions geared toward bringing novel therapies to market faster. About Alimentiv Inc. Alimentiv is a global contract research organization (CRO) providing clinical trials, central image management, precision medicine, and real-world evidence services to the pharmaceutical and biotechnology industries. Headquartered in London, Ontario, Alimentiv employs more than 500 people across its operations in Canada, the United States, Europe, Asia-Pacific, and Latin America. The organization's unique model combines the efforts of internationally recognized academic researchers and operational experts to offer integrated solutions to customers. Over the past 20 years, Alimentiv has become a recognized expert in clinical trial design, central image management solutions, outcome measure development, and precision medicine for drug development in IBD. Today, Alimentiv provides services in more than 50 countries worldwide, collaborates with leading universities and academic institutions across the globe, and partners with many leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients. Alimentiv is committed to investment in medical research and development, focusing on identifying barriers to drug development and pursuing solutions that advance IBD research. The research findings are operationalized into an efficient clinical trial methodology for clients that aligns with emerging regulatory standards. In collaboration with leading experts, Alimentiv has pioneered the development, validation, and standardization of outcome measures and technology, shaping the evolving clinical trial landscape for multiple indications and providing meaningful long-term consequences for patients, their treatment, and society. About Satisfai Health Satisfai is a leading medical solutions provider specializing in AI applications applied to large addressable markets in gastroenterology. Satisfai's solutions deliver real-time medical imagery analysis, providing clinicians with decision support intelligence that dramatically improves patient outcomes. Satisfai is supported by a highly respected board of medical clinicians and key opinion leaders who operate at the top of their fields in the many areas of gastroenterology. Satisfai enjoys a strong voice on academic panels, leading GI societies, and direct access to prominent industry players seeking to adopt new AI technologies in gastroenterology. About Virgo Virgo provides the leading cloud video capture, management, and artificial intelligence analysis platform for endoscopic medicine. Academic, integrated, and private practice healthcare providers use the Virgo platform to advance patient care through video-based research and training initiatives. Since launching, Virgo has helped physicians capture over 400,000 endoscopy procedures using industry-leading HIPAA, HITRUST, and SOC 2-compliant cloud service providers. Virgo also supports integration with all leading electronic health records systems. In 2021, Virgo launched a suite of tools called VirgoTrials, which help pharmaceutical trial sponsors and their participating trial sites accelerate patient recruitment and shorten the overall enrollment period for trials.

Read More

RESEARCH

Ora, Inc. Launches the Ora EyecupTM, a Revolutionary Ophthalmic Research Technology at Eyecelerator 2022

Ora, Inc. | September 29, 2022

Ora, Inc., the world's leading ophthalmology clinical research firm, has formally launched a revolutionary mobile research platform, Ora EyeCupTM, which promises to transform patient data capture through high-resolution imaging, artificial intelligence (AI) analysis, and real-time patient feedback. The Ora EyeCupTM, a finalist in the Most Valuable Clinical Technology Award category at the Reuters Events Pharma Awards USA 2022, will be presented by Dr. Gustavo De Moraes, Chief Medical Officer at Ora, at this year’s Eyecelerator Conference in Chicago, IL, September 29th. The Ora EyeCupTM platform is a powerful combination of hardware and software — a smartphone attachment and software application which allows patients to take high-resolution images of their eyes and track disease signs and symptoms remotely. With over 138,000 images captured to date, 98% are considered gradable by researchers and AI. Post-capture processing utilizes AI-powered image analysis for precise clinical assessments of ocular redness, tear film stability, and corneal health. Along with this, the Ora EyeCupTM ensures protocol adherence through compliance assurance diaries for both symptom tracking and therapy dosing. “At Ora, our technologists have spent the past two years developing this revolutionary system to capture patient data and provide a deeper understanding of therapeutic effect. The result is a trailblazing technology that captures high quality therapeutic data and improves the likelihood of study success.” Dr. De Moraes About Ora, Inc. Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 40 years, we have proudly helped our clients earn more than 55 product approvals and create vision beyond what they see. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world's most extensive and experienced team of ophthalmic experts, R&D professionals, and operations management to maximize the value of new product initiatives. Think ophthalmology, think Ora.

Read More