Tetra Bio-Pharma Gets Orphan Drug Status For CBD Drug

Greenmarketreport | April 22, 2020

Tetra Bio-Pharma Gets Orphan Drug Status For CBD Drug
Tetra Bio-Pharma Inc. (OTCQB:TBPMF) announced its Orphan Drug development strategy and provided a management update. The company said it is focusing on generating intellectual property including use, manufacturing, and innovative molecule protection. Tetra said it received a U.S. Food and Drug Administration (FDA) Orphan Drug Designation for secondary cannabidiol (CBD) formulation of its cannabinoid topical drug PPP004 in the treatment of epidermolysis bullosa. “Each ODD application is driven by scientific data generated by Tetra’s research and development department and in line with a commercialization strategy. Tetra is positioning itself as a world leader in cannabinoid drug development and increasing its ODD portfolio provides opportunities that will allow us to generate value for shareholders. Over the coming weeks, Tetra shall expand on its commercial ophthalmic and topical drug programs,” said Dr. Chamberland CEO & CRO, Tetra Bio-Pharma Inc.

Spotlight

One of the most important performance factors of a pharmaceutical product is the bioavailability, i.e. the release of the active compound in a human body. In a solid dosage product (e.g. tablets, powders or capsules), this is directly related to the dissolution rate, which in turn is a function of particle size. In a raw material, mainly found as powder samples, it is essential to determine the particle size and size distribution. During the pharmaceutical development, multiple ingredients are mixed. Therefore, it is critical to monitor particle size, size distribution and spatial distribution of these compounds in the intermediate/final products. Less than optimized processing, for example too little or too much mixing, can lead to agglomerates and uneven distribution, which can result in a poor content uniformity, a heterogeneity in the product, or an undesirable dissolution rate profile.


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BUSINESS INSIGHTS

FSD Pharma Announces Launch of New Corporate Website

FSD Pharma Inc. | January 24, 2022

FSD Pharma Inc. a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced today the launch of its newly designed website. The new site conveys the Company’s emerging position within the biopharmaceutical industry and its ongoing commitment to bring novel treatment solutions for brain and inflammatory disorders to millions of patients in need. “We have strategically assembled a team of scientists to help develop our powerful pipeline of next-generation therapeutics. With some of the greatest minds in neurology and inflammation working together to advance our promising therapeutic compounds, and supported by a strong balance sheet, we believe that we are very well positioned to continue the advancement of our three leading drug candidates: Lucid-MS, Lucid-PSYCH and FSD-PEA. The new look and user-friendly experience of FSD Pharma’s website reflects that, while also serving to educate clinicians, researchers, patients, and investors about our unique approach to delivering 'Total Brain Health'.” Anthony Durkacz, Interim CEO of FSD Pharma About FSD Pharma FSD Pharma Inc. is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences, Inc. a wholly owned subsidiary, is focused on pharmaceutical research and development of its lead compound, ultra-micronized palmitoyl ethylamine or FSD-PEA Lucid Psycheceuticals Inc. a wholly owned subsidiary, is focused on the research and development of its lead compounds, Lucid-PSYCH and Lucid-MS. Lucid PSYCH is a molecular compound identified for the potential treatment of mental health disorders. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders.

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BUSINESS INSIGHTS

SiO2 Materials Science and Doosan Corporation Enter Into Strategic Partnership to Accelerate Market Development in Asia

SiO2 Materials Science | December 27, 2021

Doosan Corporation, founded in 1896, one of South Korea's largest diversified conglomerates, and SiO2 Materials Science, a privately-owned U.S. advanced materials science corporation introducing breakthrough disruptive technology for packaging biological pharmaceuticals and vaccines, announced an exclusive partnership to sell, market, and distribute SIO2's vial, syringes and blood collection tubes in Asia/Oceania. The partnership will focus initially on the pharmaceutical and diagnostics markets but will extend to other markets through the joint development of new technologies. As part of the strategic partnership, Doosan will invest $100 million into SiO2 and will additionally invest in substantial infrastructure and human resources for the acceleration of the business in Asia/Oceania. The partners have defined key volume milestones over a 15 year period. "The Asia and Oceania region represents a significant market opportunity for vials and syringes specifically designed for biologic drugs and vaccines. South Korea has become a world leader in biological drug manufacturing, so it makes sense to establish a strong presence with a respected partners in the market," says Lawrence Ganti, President of SiO2 Materials Sciences The SiO2 Materials Sciences technology platform combines the benefits of glass and plastic while eliminating the drawbacks of both. The technology has been commercially validated through the packaging of hundreds of millions of COVID-19 vaccine doses around the world and is working with more than 100 active projects with leading pharmaceutical and diagnostic companies to bring their products to market in a safer container. The company was a key collaborator and part of the US Government's COVID-19 Response (formerly known as Operation Warp Speed) and has expanded its manufacturing footprint in Auburn, Alabama, more than 12-fold in the last 18 months. "South Korea is a strategic hub for biologic drug manufacturing. Doosan believes that the SiO2 technology would greatly support the packaging of these new drugs and vaccines and are proud to exclusively represent the technology in Asia," says Han Lee, Vice President of Doosan. "There is so much potential in the SiO2 technology, and we will also jointly develop new technologies and products by bringing our existing technologies and engineering minds together," says Chief Business Officer of Doosan Corporation. About SiO2 Materials Science SiO2 Materials Science is an advanced materials science corporation introducing breakthrough disruptive technology serving the biopharma, molecular diagnostic, and consumer healthcare industries. The company is located in Auburn, Alabama. The company has deep partnerships with leading professors at the foremost research universities such as University of California - Santa Barbara, University of Chicago, and MIT / Harvard. About Doosan Doosan Corporation is Korea's oldest conglomerate, founded in 1896. The company operates across multiple divisions such as: Electro-Materials, Industrial Vehicles, Fuel Cell Power, Retail, and Digital Innovation. The company is always developing innovative new business in support of materials science.

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PHARMACY MARKET

Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System

Envista Holdings Corporation | December 28, 2021

Envista Holdings Corporation announced that the U.S. Food and Drug Administration has cleared the Nobel Biocare N1™ implant system. Boasting a biologically driven design of components and forward-thinking treatment protocols, the N1™ implant system represents a significant step forward in patient-centric implant solutions. More than an implant, N1 is a comprehensive system of dedicated instruments, prosthetic components, and surgical protocols. New features of the system include an implant designed for immediate placement and predictable insertion torques, a trioval conical connection for the abutment to slide into place, and an emergence profile designed for soft tissue maintenance. Innovative site preparation for greater patient comfort The Nobel Biocare N1™ system includes the novel feature of the OsseoShaper™, an instrument that redefines site preparation and is set to reshape implantology with optimized workflows, greater patient comfort and faster treatment times. By gently 'shaping' the osteotomy at low speed and without irrigation, the OsseoShaper™ reduces noise and vibration compared to conventional drilling protocols. This leads to improved patient comfort and has been shown in pre-clinical studies to preserve vital bone. Embracing surface chemistry and digital workflows Fully embracing the new Mucointegration™ concept, the Nobel Biocare N1™ features the Xeal™ and TiUltra™ surface treatments. With their specially tailored surface chemistry and topography, TiUltra implants and Xeal abutments can benefit from this design to optimize tissue integration at every level. Nobel Biocare N1™ will be further integrated into the digital workflow with the DTX Studio™ suite, giving dental professionals more opportunities to provide patients with shorter time to teeth. "For over 50 years, Nobel Biocare has been a pioneering force behind implantology. The demand for high quality patient-centric solutions is higher than ever, and the Nobel Biocare N1™ system enables clinicians to set a new standard in personalizing, digitizing, and democratizing the implant treatment experience they can offer patients." Amir Aghdaei, Chief Executive Officer, Envista Patrik Eriksson, President Nobel Biocare, explained, "Drilling protocols have hardly changed over the past 50 years. However, the OsseoShaper™ provides a completely new approach designed for patient comfort, streamlined workflow, and improved predictability; while at the same time, respects biology to achieve fast osseointegration. We are excited to partner with clinicians to bring the N1 system to US-based patients." About Nobel Biocare Nobel Biocare is a world leader in the field of innovative implant-based dental restorations. The company's portfolio offers solutions from single tooth to fully edentulous indications with dental implant systems (including key brands NobelActive® and NobelParallel™ and ceramic implant NobelPearl™*) a comprehensive range of high-precision individualized prosthetics and CAD/CAM systems (NobelProcera®), digital solutions for treatment planning and guided surgery (NobelClinician® and DTX Studio™ suite) as well as biomaterials. Nobel Biocare supports its customers through all phases of professional development, offering world-class training and education along with practice support and patient information materials. The company is headquartered in Zurich, Switzerland. Production takes place at five sites located in the United States, Sweden, and Germany. Products and services are available in over 80 countries through subsidiaries and distributors. *Distributed by Nobel Biocare. Manufactured by Dentalpoint AG About Envista Envista is a global family of more than 30 trusted dental brands, including KaVo, Kerr, Nobel Biocare, and Ormco, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. With a foundation comprised of the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, Envista is well equipped to meet the end-to-end needs of dental professionals worldwide. Envista is one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry.

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BUSINESS INSIGHTS

Arrowhead Initiates Project to Build New Manufacturing and Lab Facilities

Arrowhead Pharmaceuticals | December 21, 2021

Arrowhead Pharmaceuticals, Inc. announced that it has completed a transaction to purchase 13 acres of land in the Verona Technology Park in Verona, WI, which is planned to be the site of an approximately 140,000 square foot drug manufacturing facility and an approximately 115,000 square foot laboratory and office facility to support process development and analytical activities. Arrowhead intends to invest between $200 million and $250 million into the buildout of the facilities. The Company expects that the new facilities will result in the creation of approximately 250 new jobs in the local area. Construction is scheduled to begin in the first quarter of 2022. Arrowhead will continue to operate additional research and development facilities in Madison, WI, and San Diego, CA. “For more than a decade, Arrowhead has been a dedicated member of the biotech community in the greater Madison, Wisconsin, area. We have built strong local relationships and are pleased to continue our growth with the new Arrowhead campus that will include a new GMP manufacturing facility and associated lab and office facility. This investment reaffirms our commitment to the Wisconsin biotech ecosystem, and we would like to thank the local agencies, who have been a pleasure to work with. Arrowhead’s pipeline of what we believe are industry leading investigational RNAi medicines continues to expand rapidly. The new Arrowhead campus will allow us to support our growing pipeline and positions us well to advance the manufacturing process, including at commercial scale, of our TRiM™-enabled drug candidates. We view this as a strong competitive advantage as we approach potential commercialization of our rapidly progressing clinical candidates.” Christopher Anzalone, Ph.D., Arrowhead’s president and CEO Major project team members include Eppstein Uhen Architects, DPS Group, D’Onofrio Kottke & Associates, Smocke & Associates, Cresa Madison, and Vogel Brothers Building Company. John Chapman, Vice President and Design Principal at EUA, said, “We are privileged to be collaborating again with Arrowhead on an inventive building design which will enable their employees to treat some of the most challenging diseases.” Completion of the lab and office space is anticipated in the first quarter of 2023 and completion of the manufacturing facility is expected in the fourth quarter of 2023. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

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Spotlight

One of the most important performance factors of a pharmaceutical product is the bioavailability, i.e. the release of the active compound in a human body. In a solid dosage product (e.g. tablets, powders or capsules), this is directly related to the dissolution rate, which in turn is a function of particle size. In a raw material, mainly found as powder samples, it is essential to determine the particle size and size distribution. During the pharmaceutical development, multiple ingredients are mixed. Therefore, it is critical to monitor particle size, size distribution and spatial distribution of these compounds in the intermediate/final products. Less than optimized processing, for example too little or too much mixing, can lead to agglomerates and uneven distribution, which can result in a poor content uniformity, a heterogeneity in the product, or an undesirable dissolution rate profile.

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