PHARMACY MARKET

MediPharm Labs Enters United States Pharmaceutical Market with Submission of FDA DMF

MediPharm Labs Corp. | February 24, 2022

MediPharm Labs Corp. a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has completed a US FDA DMF for pure natural CBD API. The DMF will enable MediPharm to supply approved API to pharmaceutical companies currently conducting late-stage research. The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025, and there are over 20 strong novel cannabinoid-based drugs currently in the late-stage research process. These projects will all require pharmaceutical approved API if commercialized. MediPharm has already shipped good manufacturing practice ("GMP") CBD for development purposes to multiple established pharmaceutical companies.

"The filing of a US DMF further advances MediPharm toward its ultimate objective of becoming a dominant supplier of API to pharmaceutical companies. This is a high value, high margin opportunity, and with the only purpose-built facility in North America to receive a domestic GMP licence specifically for the extraction of natural cannabinoids, MediPharm is positioned to capture share in this growing market. In the short to medium term, the DMF unlocks new sales channels and will enable us to further leverage the investments made to date on our high-quality pharmaceutical manufacturing platform. Over the longer-term, it ensures the Company is positioned as the go-to cannabinoid partner for pharmaceutical companies around the world."

Bryan Howcroft, CEO, MediPharm


About MediPharm Labs
Founded in 2015, MediPharm specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, API and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets.

Spotlight

This collaboration will make AroCell’s patented biomarker assay available both as a service and as in the already existing AroCell TK 210 ELISA kit for measurements of TK1 protein concentrations in human serum samples. This will provide maximum flexibility for our customers in the USA. It also extends the services that Corgenix offers in their CAP compliant CLIA-lab (Clinical Laboratory Improvement Amendments-lab). Corgenix has over 25 years of experience in the In Vitro Diagnostic (IVD) industry focused on product development, manufacturing, regulation, distribution and contract services with a CAP/CLIA-lab based in Colorado, USA. A CAP/CLIA-lab is a clinical laboratory for human sample testing that follow CAP standards in USA. 


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BUSINESS INSIGHTS

Avidien Technologies Receives $4M Investment from BroadOak Capital Partners

Avidien Technologies | February 02, 2022

Avidien announced a new financing round of $4M from BroadOak Capital Partners. The investment will help Avidien expand its product roadmap, scale commercial production, and better serve research and pharmaceutical clients. "The partnership with BroadOak is exciting and ushers in the next phase for Avidien by creating the opportunity to quickly scale up the business with investments in new products, sales, marketing, and manufacturing." Avidien CEO and Founder Rich Cote Avidien's flagship product, the microPro 300, provides precision semi-automated 96 and 384 channel pipetting to hundreds of biotech, medical testing, and research laboratories worldwide. The compact and portable liquid handling platform has built a loyal customer base thanks to its innovative design, intuitive interface, and industry-leading capabilities. The microPro 300 fills gaps in automation workflows by streamlining repetitive pipetting tasks and ensuring accurate, repeatable liquid transfers. BroadOak Capital Partners is a life sciences focused financial institution with a track record of supporting companies at the forefront of major industry trends. "Aviden's affordable pipette automation platform sets a new standard for common research methods and is at the cutting edge of laboratory automation technology. We're proud to partner with the Avidien team to help them achieve even greater growth," said Bryan Poltilove, Operating Partner at BroadOak Capital Partners. Mr. Poltilove is also joining Avidien's Board of Directors to guide the company's next phase of business expansion. About Avidien Technologies Avidien Technologies is a Massachusetts based company that manufactures innovative and precision liquid handling solutions that are deployed in life science labs around the world. About BroadOak Capital Partners BroadOak Capital Partners, with headquarters in Washington, DC and San Francisco, is a life sciences focused financial institution that provides direct investment and investment banking services to companies in the research tools and consumables, diagnostics, biopharma services, and adjacent markets. BroadOak has led or participated in investments in more than 50 companies across multiple funds and investment vehicles.

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BUSINESS INSIGHTS

ALR Technologies Completes Definitive Manufacturing Agreement with Infinovo Medical for the GluCurve Pet CGM Hardware

ALR Technologies | June 30, 2022

ALR Technologies SG Pte. Ltd the diabetes management company, announces the completion of a definitive manufacturing agreement with Infinovo Medical Co. Ltd to manufacture and supply the Continuous Glucose Monitor hardware that will be utilized as part of the ALRT GluCurve Pet CGM. The Manufacturing Agreement gives ALRT the exclusive global rights to distribute the Infinovo CGM hardware for the animal health market, providing long-term production and supply. Subject to the satisfaction of all closing conditions it is expected that initial deliveries of product by Infinovo will be made during Q4 of 2022 “Executing the Manufacturing Agreement with Infinovo marks another major milestone in our path to commercialization and profitability. Our next targeted milestone is securing distribution for the ALRT GluCurve Pet CGM. We have been working with many of the largest global distributors and pharmaceutical companies in animal health, evaluating different distribution opportunities ranging from joint venture partnerships to sales and distribution agreements. We believe we have narrowed in on the right company and right deal structure to best bring value to our shareholders and to those who care for diabetic pets. We hope to announce the details of this pivotal next step in the near future.” Sidney Chan, Chairman and CEO of ALRT The Manufacturing Agreement is subject to certain closing conditions including the completion of a distribution agreement with a third party by July 31, 2022. About Infinovo Medical Co. Ltd Founded in 2016, Infinovo is an innovative medical technology company, focusing on developing an accurate and affordable CGM for patients which will be available for both Type 1 and Type 2 Diabetics. ALR Technologies SG Pte. Ltd. ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, and a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data. In addition, the animal health division of ALRT has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans. ALR Technologies SG Pte. Ltd. is controlled by ALR Technologies Inc., a Company with its shares traded on the OTC:QB under the symbol “ALRT”. On May 17, 2022, ALR Technologies Inc. announced an Agreement and Plan of Merger and Reorganization for the sole purpose of changing the Company’s jurisdiction of incorporation from Nevada to Singapore (the “Redomicile Merger Agreement”). The Redomicile Merger Agreement is subject to the required approval of the Company’s stockholders, requisite regulatory approvals, the effectiveness of the registration statement on Form F-4 filed by ALRT related to the Redomicile Merger, and other customary closing conditions. The Redomicile Merger is expected to be completed during the third quarter of 2022. See the Form 8-K filed May 20, 2022, by ALR Technologies Inc. for further information about the Redomicile Merger Agreement.

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BUSINESS INSIGHTS

Ankura Launches Pharmaceutical Data Integrity Solution

Ankura | March 09, 2022

Ankura Consulting, LLC a leading global expert services and advisory firm announced the expansion of its Pharmaceutical and Biopharma Regulatory Compliance offering with the addition of a Pharmaceutical Data Integrity solution within the Data and Technology practice, bolstering its comprehensive client advisory capabilities. With this solution, Ankura has enhanced its team of experts to support pharmaceutical clients' compliance with the Data Integrity guidelines of multiple regulators through advanced digital technology. The offering includes Early Warning System (EWS), an automated platform to help identify data integrity anomalies in real-time and assist companies in performing forensic data integrity investigations and remediation for any regulatory action such as form 483, warning letter, and import alert. "In the endeavour to embrace industry 4.0, the pharmaceutical industry should explore giving up manual and fragmented means of managing compliance procedures and implement digital technologies in the quality control laboratories to proactively identify any data integrity (DI) gaps in real-time. EWS enables this transition and allows for early identification of any anomaly, falsification activities, and DI deviations from a regulatory compliance perspective," Amit Jaju, Senior Managing Director in Ankura's Data & Technology practice The EWS solution also solves the challenge of integrating multiple quality systems (such as CDS, NON CDS and LIMS) into one platform, enabling the quality control department to take advantage of the integrated monitoring capabilities and providing alerts for any non-compliant activities. It also provides the flexibility to customize and deploy the solution to an on-premises environment and customize the workflows and analytics models to each organization. "The cost of being non-compliant to data integrity can be a high-priced affair, and in many cases becomes difficult for companies and organizations to gain back the trust of regulators once breached. Many regulators now recommend appointing a qualified consultant for the investigation and remediation activity," said Paul Walker, Senior Managing Director in Ankura's Data & Technology practice. In light of this, Ankura's Data Integrity investigation and remediation offering is a pivotal tool to support clients in performing comprehensive data integrity analysis using big data and advanced analytical approach on 100% of the data as compared to the sample manual review approach followed in the industry." About Ankura Ankura Consulting Group, LLC is an independent global expert services and advisory firm that delivers services and end-to-end solutions to help clients at critical inflection points related to change, risk, disputes, finance, performance, distress, and transformation. The Ankura team consists of more than 1,700 professionals serving 3000+ clients across 55 countries who are leaders in their respective fields and areas of expertise. Collaborative lateral thinking, hard-earned experience, expertise, and multidisciplinary capabilities drive results and Ankura is unrivaled in its ability to assist clients to Protect, Create and Recover Value.

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BUSINESS INSIGHTS

NextRNA Launches with $56 Million in Funding to Bring Transformative Non-Coding RNA-Directed Medicines to Patients

NextRNA Therapeutics | March 02, 2022

NextRNA Therapeutics, a biotechnology company unlocking the potential of non-coding RNAs to develop transformative therapeutics, announces its launch with $9.3 million in seed financing and a $46.8 million Series A led by Cobro Ventures and Lightchain Capital, with additional participation from Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors. Proceeds will be used by the company to augment its target and drug discovery engine, expand its pipeline, and advance lead programs. The vast majority of DNA is copied into RNAs that do not make proteins. These RNA molecules, called “non-coding RNAs,” play essential roles in cells by interacting with and modulating the activities of proteins. These interactions can drive pathogenic processes in multiple disease areas, including oncology, immunology, and neurology. Non-coding RNAs, in particular long non-coding RNAs, and their interacting proteins therefore represent a vast and untapped class of novel therapeutic targets. “NextRNA is uniquely positioned to be the leader in non-coding RNA-directed medicines. We have established a robust target and drug discovery engine to systematically identify disease-relevant long non-coding RNAs and their interacting proteins. By developing selective small molecules to drug these interactions, we plan to translate discoveries of non-coding RNA targets into a robust pipeline of transformative therapies across multiple disease areas.” Dominique Verhelle, Ph.D., MBA, co-founder, chief scientific officer, and interim chief executive officer, NextRNA NextRNA was established based on pioneering work by Carl Novina, M.D., Ph.D., at Dana-Farber Cancer Institute. “By understanding the interactions between long non-coding RNAs and specific proteins, we can decode the function of long non-coding RNAs and apply it to create medicines,” said Dr. Novina, co-founder of NextRNA. Since its founding in January of 2021, NextRNA has established its initial team, built out the target and drug discovery engine, and advanced two small molecule programs in oncology and immunology. “NextRNA is at the forefront of innovation in the field of non-coding RNAs,” said Todd Kaloudis, Managing Director at Cobro Ventures. “There is growing excitement around the potential of non-coding RNA-directed medicines, and we are pleased to have such an experienced team focused on NextRNA’s vision of bringing transformative therapies to patients.” About NextRNA Therapeutics NextRNA is a biotechnology company with a mission to translate pioneering science into transformative therapeutics for the benefit of patients. The company is leveraging its proprietary technology platform to systematically identify disease-relevant non-coding RNAs and their interacting proteins, and to develop selective small molecules to drug these interactions. NextRNA investors include Cobro Ventures, Lightchain Capital, Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors.

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Spotlight

This collaboration will make AroCell’s patented biomarker assay available both as a service and as in the already existing AroCell TK 210 ELISA kit for measurements of TK1 protein concentrations in human serum samples. This will provide maximum flexibility for our customers in the USA. It also extends the services that Corgenix offers in their CAP compliant CLIA-lab (Clinical Laboratory Improvement Amendments-lab). Corgenix has over 25 years of experience in the In Vitro Diagnostic (IVD) industry focused on product development, manufacturing, regulation, distribution and contract services with a CAP/CLIA-lab based in Colorado, USA. A CAP/CLIA-lab is a clinical laboratory for human sample testing that follow CAP standards in USA. 

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