BUSINESS INSIGHTS, PHARMACY MARKET
Framework Solutions, LLC | March 02, 2023
On March 1, 2023, Framework Solutions, a leading clinical to commercial solutions provider, announced that it has acquired ONIX Life Sciences, a consultancy focused on regulatory operations services for the life sciences industry. The acquisition will enable both firms to expand their global reach and strengthen their service capabilities by providing clients with a broader range of critical services. ONIX's expertise in eCTD Submissions, Publishing, and eCTD Lifecycle Management has helped clients submit their regulatory documents to health authorities worldwide, including the FDA and EMA.
ONIX, based in the United Kingdom, has successfully completed eCTD submissions for over 100 clients globally across North America, Europe, South America, the Middle East, and Asia Pacific regions. In addition, ONIX is proud of its accomplishment of never having an eCTD technical rejection and never missing a deadline since its inception in 2010.
Frameworks, headquartered in Connecticut, received a growth investment from WestView Capital Partners in 2021 to develop end-to-end solutions for clinical and commercial-stage organizations in the life sciences industry. WestView Capital Partners, a Boston-based growth equity firm, focuses on investing in middle-market companies with a longstanding dedication to the life sciences services industry.
The transaction terms between Framework Solutions and ONIX Life Sciences were not disclosed.
Frameworks CEO Joe Walsh commented, "We are thrilled to welcome Jasbir and the ONIX team to Frameworks." He further emphasized, "ONIX has built an impeccable reputation in the industry and we are excited to bring Regulatory Operations services to our customers. We look forward to working with Jas as we continue to expand our suite of service offerings to best serve the clinical to commercial-stage needs of life sciences clients."
(Source – PR Newswire)
About Framework Solutions, LLC
Framework Solutions is a leading clinical to commercial solutions provider to pharmaceutical and biotechnology companies with the aim of promoting customer success. The company provides both strategic and tactical solutions in various fields, including Regulatory Affairs, Medical Affairs, MLR, and Commercialization. These services are reinforced by the Technology Group, which delivers tech-enabled solutions and integrated enterprise help desk and infrastructure support. Over 100 clients, from emerging biotech to large pharma, have utilized its services. Its operation centers are located in Europe, North America, and Asia, allowing us to provide these services globally.
BUSINESS INSIGHTS, PHARMACY MARKET
Prnewswire | April 05, 2023
PathAI, a global leader in AI-powered pathology, announced the launch of PathExplore™, the world's first structured, standardized and scalable panel of human interpretable features (HIFs) offering unprecedented resolution of the tumor microenvironment (TME) from H&E whole-slide images. Powered by artificial intelligence, PathExplore1 spatially characterizes the TME with single-cell resolution, giving oncology drug developers the ability to unlock insights to inform the next phase of targeted oncology drug development.
The last decade has seen significant strides in oncology therapeutic development, but challenges remain – many cancer patients do not respond to available treatment, and many aren't eligible for potentially transformative therapies because of a lack of actionable insight into their disease. Researchers are looking to the tumor microenvironment, one of the most promising areas of oncology research, for answers and insights that will impact patient outcomes.
"PathExplore will enable researchers to identify novel spatial signatures predictive of outcomes," said Andy Beck, M.D., Ph.D., chief executive officer and co-founder of PathAI. "We're hopeful that by giving oncology drug developers access to this level of detail and data from routine H&E samples, this next generation of pathology will drive advances in cancer therapy development."
Current technologies to measure and analyze the TME force researchers to make tradeoffs between resolution and scalability. Now with PathExplore, drug developers will have the ability to analyze the TME with deep resolution using a scalable platform that can be deployed on massive numbers of patient samples. PathExplore produces a panel of more than 600 quantitative HIFs: standardized and reproducible measures of counts, densities, areas and spatial relationships across cell types and tissue regions. PathExplore also generates overlay visualizations of cell types and tissue regions, delivered on PathAI's AISight™ Translational Research platform.
PathExplore has been trained using over 6.5 million pathologist annotations on 66,000 slides. It is currently available for breast cancer, colorectal cancer, gastric cancer, melanoma, non-small cell lung cancer, pancreatic cancer, prostate cancer, and renal cell carcinoma, with more indications planned to launch later this year, including ovarian and bladder cancers. The standardized, structured quantification of the TME across disease areas will enable reproducible, comparable, and scalable analysis across drug programs.
"PathExplore will shift the research paradigm, bypassing long standing constraints we experience with some of the existing multi-omics modalities and allowing for more open exploration and discovery of relationships that were not identifiable by human analysis alone," said Mike Montalto, PhD, chief scientific officer at PathAI. "The degree of granularity, speed, efficiency and scale delivers unmatched insights that will change the way we view the tumor microenvironment."
PathAI's HIFs have been used in over 15 scientific abstracts, presentations, and publications. To learn more about PathExplore, visit www.PathExplore.com or visit us at booth 315 at the American Association for Cancer Research (AACR) April 14th-19th in Orlando, FL.
PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve diagnostic efficiency and accuracy, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases.
Globenewswire | May 09, 2023
Eyenovia, Inc. an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, announced that the U.S. Food and Drug Administration (FDA) has approved Mydcombi 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority.
Mydcombi is designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. The product is contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation.
“The approval of Mydcombi, our first FDA approved product, represents the culmination of years of tireless effort by the entire Eyenovia team, and I would like to express my sincere gratitude to the associates and technical experts who helped advance this important program through this transformational milestone,” stated Michael Rowe, chief executive officer of Eyenovia. “We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024.”
“Perhaps more importantly, FDA approval of Mydcombi provides critical validation of the Optejet as it is the first product approved using the Optejet platform, which is core not only to our internal development programs, including MicroLine for presbyopia, but our partnered programs as well. We see opportunities to unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye. I am confident in our ability to maintain our current momentum.”
“I am proud of our team for this significant achievement – which represents many ‘firsts’ for eye care,” stated Dr. Sean Ianchulev, Founder and Chairman of Eyenovia’s Board of Directors. “The use of eye dropper bottles has presented challenges for dosing in ophthalmologic settings in millions of patients. We can do better now using sophisticated micro-array print delivery with physiologic dosing that is similar to the natural tear film volume.”
Eyenovia management will provide additional updates on Mydcombi as well as its ongoing development programs and partnerships during its regularly scheduled first quarter 2023 update conference call and webcast on May 11th, 2023.
About Eyenovia, Inc.
Eyenovia, Inc. is a commercial stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the commercialization of Mydcombi for mydriasis, as well as the ongoing late-stage development of medications in the Optejet device for presbyopia and myopia progression.