CANNABIS STOCKS BLAZE AS FDA EXPEDITES LANDMARK CBD RULES

July 16, 2019 | 103 views

Cannabis stocks got a boost this week after the US Food and Drug Administration announced it would expedite creating a regulatory framework for CBD. CBD is the non-psychoactive ingredient in cannabis, which allegedly has wellness properties, and can treat a range of various conditions, including pain management.

Spotlight

Pharmaceutical Society of Australia

The Pharmaceutical Society of Australia (the 'Society') is the Peak National Body for all Australian pharmacists. The Society was established by the state professional pharmaceutical societies in 1977, some of which had been in existence for over 100 years. Its provides the profession with a national identity, an opportunity to effectively regulate its affairs, and achieve better coordination in consultation and liaison with the Commonwealth Government, other professions and industry. The Society supports pharmacists’ commitment to high standards of patient care and continuing professional education, and represent their role as frontline health professionals; and is the leading advocacy organisation for pharmacists, influencing attitudes, opinions and policies through representation, networking, consultation, continuing education, practice support, standards, guidelines and a range of publications and health promoting programs and resources.

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BUSINESS INSIGHTS

3D Bioprinting Forefronts Technology in Pharmaceutical & Regenerative Medicine

Article | June 30, 2022

3D printing technology has emerged as a significant driver in the ongoing radical shift across several industrial domains' production processes. The incorporation of 3D printing into tissue engineering, through the use of life cells encapsulated in specialized synthetic or natural biomaterials (e.g. chitosan) as bioinks. This is laying the groundwork for numerous innovative solutions for healthcare and biomedical challenges, heralding new frontiers in medicine, pharmaceuticals, and biotechnology. 3D Bioprinting: A New Pathway in Medicine Additive manufacturing, which is the process of joining materials to create objects using computer-aided design (CAD) model data, such as 3D bioprinting, has the potential to disrupt the global pharmaceutical and regenerative medicine industry. Today, this technology has permeated countless industries, including pharmaceuticals, automobiles, dental, electronics, and others. The successful implementation of additive manufacturing in the healthcare sector has led to the development of surgical instruments, medical devices, and body implants. The past ten years have seen significant progress in the bioprinting arsenal, with many revolutionary and cutting-edge innovations, helping 3D bioprinting emerge as one of the most exciting and promising technologies. This advanced additive manufacturing has the potential to impact a wide variety of medical applications. Some of the applications making use of 3D bioprinting are Medical Education and Training Drug Delivery Manufacturing of Surgical Instruments Surgery Preparation Production of Personalized Prosthetics It has been estimated that 3D bioprinting in the medical field will be worth $3.8 billion by 2026, in comparison to the $1.4 billion registered in 2020. The domain’s compound annual growth rate is forecast to reach 18.2% between 2021 and 2026. The Way Ahead A large number of medical researchers and pharmaceutical companies are experimenting with printing de novo organs such as hearts, kidneys, livers, lungs, and skin, among others, to assist with the study of organs in-vitro, the development of drugs for specific diseases, and decrease the shortage of organs for transplant. For instance, Organovo, a medical laboratory and research company based in the United States, presented pre-clinical data for the functionality of its liver tissue in a program for type 1 tyrosinemia, a disease that makes it difficult for the body to metabolize the amino acid tyrosine. A multiplicity of such developments will increase the penetration of 3D bioprinting in the medical field, presenting opportunities for pharmaceutical leaders to invest in the domain.

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PHARMA TECH

Biomaterials Emerging as a Blessing in the Pharmaceutical Industry

Article | July 15, 2022

Biomaterials are materials (natural or synthetic) that are biologically compatible with the human body and are used to replace, restore, support, or enhance the biological functions of damaged tissues while being in constant contact with body fluids. Over the past couple of decades, biomaterials have made their mark in the rapidly evolving pharmaceutical and medical fields. These materials are designed to interact with living biological tissue and are used for therapeutic and diagnostic purposes. Previously, biomaterials were only used in medical devices to replace or treat tissues or improve organ functions. However, it was later discovered that the term "non-viable" was inappropriate as biomaterials can be used for a variety of medical applications other than implanted devices. Growing Cases of Chronic Wounds Deepen the Penetration of Biomaterials There is a significant rise in the side effects caused due to the use of non-biocompatible materials for the treatment of chronic wounds caused by conditions such as malignant tumors, diabetes, infections, and vasculopathy, among others. Using biodegradable and biocompatible drug carriers is one way to avoid or reduce the side effects that may result from drug delivery to cells with enhanced efficiency and performance during the health rehabilitation process. Also, the use of biomaterials assists in enhancing chronic wound healing through anti-infection and antioxidant effects, immunoregulation, debridement, extracellular matrix remodeling, and angiogenesis, further increasing the adoption of pharmaceutical products made using these materials. Due to their favorable properties, biomaterials are gaining massive traction across the pharmaceutical industry. Here are some of the applications of biomaterials as follows. Dental Injectable Medical Implants Organ Regeneration (Heart, Lungs, Knee, Tracheal graft, others) Drug Delivery Regenerative Medicines Tissue Engineering Wound Healing Disease Treatment The Way Forward Leading manufacturers of biomaterials are aiming at expanding their biomaterial production capacity to strengthen their footprint and gain a competitive edge in the industry. For instance, in 2020, Evonik Industries AG, a German specialty chemicals company, announced the launch of a new biomaterial manufacturing facility in Birmingham, the U.S. to expand the company’s territory across North America. Following the trend, biomaterials are anticipated to create massive investment prospects for pharmaceutical players.

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PHARMA TECH

Use of AI: Reshaping the Pharmaceutical Industry

Article | July 19, 2022

For decades, the pharmaceutical industry has counted on state-of-the-art technologies to ensure the market entry of safe and dependable medications. The recent pandemic has shown how important it is for drug companies to get new drugs and vaccines on the market as soon as possible. The incorporation of artificial intelligence and machine learning technologies has greatly benefited the consumer healthcare business and the pharmaceutical industry. These technologies have been indispensable in the field of augmented intelligence, where they are used for applications such as disease detection and diagnosis, research and development, drug manufacturing, and others. How is AI Being Used Across the Pharmaceutical Sector? AI and ML are finding a plethora of applications across the pharmaceutical sector, starting from managing the process of clinical trial databases to drug discovery and disease diagnosis and treatment. These advanced technologies have further gained immense popularity with the advent of the COVID pandemic and the race to discover effective vaccines. The top-level uses of AI across the pharmaceutical sector are as follows Personalized Treatment/ Digital Therapeutics – AI is extensively being used to identify and assist drug developers to provide reliable and accurate insights for developing personalized therapeutics. Disease Identification/ Suggestive Treatment – With robust assessing abilities, AI is finding applications for the diagnosis of diseases ranging from Covid-19 to oncology to degeneration in the eyes. Drug Discovery and Manufacturing – AI assists in screening and comparing the predicted success rate of drug compounds based on biological factors with the results of the initial screening process such as rapid RNA and DNA quantification. Clinical Trials – The technology helps in identifying the most suitable candidate for the clinical trial on the basis of disease conditions, history, and additional attributes covering infection rates, ethnicity, and demographics to study the impact of the drug. The Way Ahead With growing applications in the development of novel therapeutic medications, shifting patient inclination toward personalized medicines, and the introduction of advanced medical fields such as gene therapy, AI is estimated to transform the pharmaceutical

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PHARMA TECH

How Pharma Is Utilizing AI and Analytic Capabilities to Produce Positive Results

Article | July 7, 2022

Applications for AI are as diverse as the industries that employ them, and pharma has identified the particular varieties of AI that are most effective in attaining quicker, more fruitful results across a variety of business activities. In a world where every second counts, pharma and biotech businesses are under pressure to shorten the time to insight and deliver success. As a result, leading organizations quickly realize the potential of artificial intelligence (AI) as a crucial tool for advancing their operations. Leading pharma and biotech firms have realized the potential of AI and are utilizing it to boost productivity and innovation across the board, from production to drug discovery. Their procedures have significantly benefited from the application of machine learning (ML) and natural language processing (NLP), and the results are only becoming better because AI gets stronger and "smarter" the more data it processes. Advantages Pharma Industry Can Leverage Increased effectiveness across the spectrum in the pharmaceutical industry Drug discovery accelerates Superior disease surveillance, detection, and prevention Clinical trials with lower risk Greater insight into the client NLP is used to turn clinical trial data that is text-intensive and highly categorized into the data utilized in machine learning (ML) models, allowing the computer system to apply patterns to the data and generate insights. Clinical trial data is structured and enriched, making it possible to analyze and visualize the data for use in successful plans and strategies for clinical trial design, manufacturing, marketing, and other areas. Faster time to insight and improved business outcomes are the end results. A particularly true principle of machine learning applications is that the outcomes from using AI applications are only as reliable as the data itself. The Pharma Intelligence offering, which combines high-quality, extensive data from the pharmaceutical and biotechnology industries with advanced analytics and AI applications, has assisted customers with high-value products in resolving some of their most difficult key problems, including target prioritization, modalities innovation, competitive benchmarking, clinical trial design and deployment, and more.

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Spotlight

Pharmaceutical Society of Australia

The Pharmaceutical Society of Australia (the 'Society') is the Peak National Body for all Australian pharmacists. The Society was established by the state professional pharmaceutical societies in 1977, some of which had been in existence for over 100 years. Its provides the profession with a national identity, an opportunity to effectively regulate its affairs, and achieve better coordination in consultation and liaison with the Commonwealth Government, other professions and industry. The Society supports pharmacists’ commitment to high standards of patient care and continuing professional education, and represent their role as frontline health professionals; and is the leading advocacy organisation for pharmacists, influencing attitudes, opinions and policies through representation, networking, consultation, continuing education, practice support, standards, guidelines and a range of publications and health promoting programs and resources.

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Neuraxpharm and Panaxia Global have entered a comprehensive agreement to start a business collaboration

Panaxia Global, Neuraxpharm | July 22, 2020

Neuraxpharm, a leading European pharmaceutical company specialized in CNS, and Panaxia Global, the controlling owner of Panaxia Labs Israel (Panaxia Israel) (TASE: PNAX), Israel's largest medical cannabis manufacturer, announced today they have entered a definite agreement to start a business collaboration for marketing Panaxia's medical cannabis products in Germany, Europe's largest and fastest-growing market for cannabis in Europe. The agreement, which anchors a previous MOU entered by the companies, includes exclusivity for Panaxia products, as well as an option for scaling the distribution to additional countries, also including further major European countries. The agreement is one of a kind in the cannabis industry. It represents the first time a global pharma company of Neuraxpharm caliber marketing medical cannabis products as part of its broad prescription and non-prescription product portfolio. On top of distributing the products to pharmacies through local distributors, the venture will focus on marketing efforts to the relevant target audiences in Germany, namely the prescribing physicians, and the patients. The marketing activity is critical for the success of commercial sales and will be implemented according to the standards used in the pharmaceutical industry.

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Pivot Pharma Launches Cannabis and Nutraceutical Facility in Quebec

Market Exclusive | November 26, 2019

Pivot Pharmaceuticals has launched its cannabis and nutraceutical manufacturing facility in Dollard-des-Ormeaux, Quebec, Canada. The facility, along with R&D and pilot-scale laboratories, is comprised of 43 000 square feet of production and packaging space designed to optimize the manufacturing processes of Pivot branded value-added CBD and nutraceutical consumer products. The company plans to start the production activities in the next three months, pending the Health Canada license reception. Pivot is nearing the completion of its state-of-the-art building and is preparing the submission of its site evidence package to Health Canada, the final step toward securing the Health Canada license. The infrastructure will be used to develop novel formulations and production of Pivot’s CBD, phytocannabinoid and micronutrient product lines using Pivot’s patented and drug delivery technologies. “This facility will enable us to launch our product pipeline in the Canadian market and thus further consolidating Pivot’s strategic positioning with ramping sales of specialty CBD products and micronutrient formulations in Germany and planed product launches in the U.S. marketplace in Q1 2020,” Pivot CEO Dr. Toni Rinow stated.

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FDA Approves Yale Medical Cannabis Human Trials

Ganjapreneur | November 12, 2019

The Food and Drug Administration has granted approval to the Yale School of Medicine and CT Pharma for human drug trials to study the efficacy of cannabis-based medicines, according to a Connecticut Public Radio report. The study will be the first with FDA approval to test cannabis on human subjects. Yale University School of Medicine’s Dr. Rajita Sinha, the lead researcher for the clinical trial, said the studies will attempt to figure out how medical cannabis works, who it works for, what symptoms can be alleviated, dosages, and whether there is “a need for refinement.” Michael Fedele, board chair of the Portland, Connecticut-based CT Pharma, told CPR that he hopes the study will result in the first FDA-approved cannabis-based medicine to be manufactured in the U.S. According to the FDA, the agency “is aware that there is considerable interest in the use of marijuana to attempt to treat a number of medical conditions” and does support “research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research.”

Read More

Neuraxpharm and Panaxia Global have entered a comprehensive agreement to start a business collaboration

Panaxia Global, Neuraxpharm | July 22, 2020

Neuraxpharm, a leading European pharmaceutical company specialized in CNS, and Panaxia Global, the controlling owner of Panaxia Labs Israel (Panaxia Israel) (TASE: PNAX), Israel's largest medical cannabis manufacturer, announced today they have entered a definite agreement to start a business collaboration for marketing Panaxia's medical cannabis products in Germany, Europe's largest and fastest-growing market for cannabis in Europe. The agreement, which anchors a previous MOU entered by the companies, includes exclusivity for Panaxia products, as well as an option for scaling the distribution to additional countries, also including further major European countries. The agreement is one of a kind in the cannabis industry. It represents the first time a global pharma company of Neuraxpharm caliber marketing medical cannabis products as part of its broad prescription and non-prescription product portfolio. On top of distributing the products to pharmacies through local distributors, the venture will focus on marketing efforts to the relevant target audiences in Germany, namely the prescribing physicians, and the patients. The marketing activity is critical for the success of commercial sales and will be implemented according to the standards used in the pharmaceutical industry.

Read More

Pivot Pharma Launches Cannabis and Nutraceutical Facility in Quebec

Market Exclusive | November 26, 2019

Pivot Pharmaceuticals has launched its cannabis and nutraceutical manufacturing facility in Dollard-des-Ormeaux, Quebec, Canada. The facility, along with R&D and pilot-scale laboratories, is comprised of 43 000 square feet of production and packaging space designed to optimize the manufacturing processes of Pivot branded value-added CBD and nutraceutical consumer products. The company plans to start the production activities in the next three months, pending the Health Canada license reception. Pivot is nearing the completion of its state-of-the-art building and is preparing the submission of its site evidence package to Health Canada, the final step toward securing the Health Canada license. The infrastructure will be used to develop novel formulations and production of Pivot’s CBD, phytocannabinoid and micronutrient product lines using Pivot’s patented and drug delivery technologies. “This facility will enable us to launch our product pipeline in the Canadian market and thus further consolidating Pivot’s strategic positioning with ramping sales of specialty CBD products and micronutrient formulations in Germany and planed product launches in the U.S. marketplace in Q1 2020,” Pivot CEO Dr. Toni Rinow stated.

Read More

FDA Approves Yale Medical Cannabis Human Trials

Ganjapreneur | November 12, 2019

The Food and Drug Administration has granted approval to the Yale School of Medicine and CT Pharma for human drug trials to study the efficacy of cannabis-based medicines, according to a Connecticut Public Radio report. The study will be the first with FDA approval to test cannabis on human subjects. Yale University School of Medicine’s Dr. Rajita Sinha, the lead researcher for the clinical trial, said the studies will attempt to figure out how medical cannabis works, who it works for, what symptoms can be alleviated, dosages, and whether there is “a need for refinement.” Michael Fedele, board chair of the Portland, Connecticut-based CT Pharma, told CPR that he hopes the study will result in the first FDA-approved cannabis-based medicine to be manufactured in the U.S. According to the FDA, the agency “is aware that there is considerable interest in the use of marijuana to attempt to treat a number of medical conditions” and does support “research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research.”

Read More

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