Tetra Bio-Pharma Gets Orphan Drug Status For CBD Drug

Greenmarketreport | April 22, 2020

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

We have pledged to donate an average of 1.4 billion treatments for each of the ten years from 2011 to 2020. The 14 billion treatments over this period will help eliminate or control the nine neglected diseases that represent more than 90% of the global neglected diseases burden. We are on track with those commitments and in some cases actual donations are double the commitments made.

Spotlight

We have pledged to donate an average of 1.4 billion treatments for each of the ten years from 2011 to 2020. The 14 billion treatments over this period will help eliminate or control the nine neglected diseases that represent more than 90% of the global neglected diseases burden. We are on track with those commitments and in some cases actual donations are double the commitments made.

Related News

RESEARCH

Biognosys Launches Next-Generation Blood Biomarker Discovery Solution

Biognosys | November 10, 2021

Biognosys, a leader in proteomics solutions for drug discovery and development, announces the launch of its next-generation blood biomarker discovery solution, which will be offered as a contract research service. The service is designed to help researchers decipher the complexity of the blood proteome and unlock unbiased discoveries for pharma and diagnostics development and precision medicine. The launch will feature a series of events and resources that detail the science and technology behind the new solution, as well as its applications Launch webinar on November 9, entitled: “Plasma Proteomics: The Next Frontier of Biomarker Discovery in the Precision Medicine Era.” Presentation and exhibition at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 12-14 in Washington, D.C. The new service offers unprecedented depth, quantitative precision, and throughput for discovery research. The solution will search the complete plasma proteome to quantify up to 3,000 of the most relevant proteins and measure tens of thousands of peptide-level datapoints to provide a deep understanding of key disease pathways. The solution can be applied across all biological species and to any other biofluid, such as cerebrospinal fluid or urine. In addition to the biofluid biomarker discovery service, an improved tissue biomarker discovery service is available, offering an industry-leading depth of 10,000 proteins. Both solutions are based on Biognosys’ proprietary, patented Hyper Reaction Monitoring (HRM™) technology and its optimized Liquid Chromatography - Mass Spectrometry (LC-MS) workflow. The clinical transferability of this technology allows quick transition from early stage discovery to specific, targeted panels that can be applied in a regulated setting. Kanna Palaniappan, PhD, Staff Scientist at Freenome, a company that develops blood tests for early cancer detection, powered by a multi-omics platform, testifies: “We have used Biognosys’ services for a number of biomarker discovery studies focused on improving cancer detection, taking advantage of their constantly improving platform, and their ability to run large-scale studies while maintaining high data quality. We have had a valuable and productive relationship and we look forward to future collaborations.” “We are thrilled to offer customers our innovative, next-generation biomarker discovery solution and enable them to gain biological insights beyond what pre-defined panels can provide. By diving deep into the plasma proteome with an unbiased view, we profile the proteins that are of highest relevance to our customer’s disease areas of focus. This is what we call true discovery.” Kristina Beeler, PhD, Chief Business Officer of Biognosys Lukas Reiter, PhD, Chief Technology Officer of Biognosys states: “Mass spectrometry-based proteomics is the ideal tool to explore the blood proteome in an unbiased manner. Our continuous R&D improvements have enabled us to reach an unprecedented depth to quantify the very low abundant protein ranges that are of highest biological significance, while ensuring high scalability for clinical research.” About Biognosys Biognosys is a leader in next-generation proteomics, dedicated to transforming life science by inventing and developing cutting-edge proteomics technology and solutions and making them widely available for pharmaceutical and biotechnology researchers and proteomics experts. The Company offers a versatile portfolio of proprietary proteomics services, software, and kits that provide a multi-dimensional view of protein expression, function, and structure in all biological species and sample types. Biognosys’ unique, patented technologies utilize high-resolution mass spectrometry to quantify thousands of proteins across thousands of samples with industry-leading precision, depth, and throughput. Through advanced data analytics, Biognosys translates data into actionable insights for R&D and clinical research.

Read More

RESEARCH

Gilead gets WHO cold shoulder for remdesivir in COVID-19, launches speedy defense

Gilead | November 21, 2020

Gilead Sciences’ Veklury, better known as remdesivir, is so far the only COVID-19 therapy officially approved by the FDA, but the World Health Organization has some other ideas about the drug’s worth. At clear odds with the FDA’s approval, the WHO has for now recommended against the use of remdesivir in any hospitalized patients—regardless of disease severity—after an expert panel said it had found no evidence that remdesivir has any meaningful effect on saving lives and other important outcomes for patients, the international body said Thursday. A “disappointed” Gilead immediately fought back. It pointed to remdesivir’s inclusion in several other organizations’ guidelines based on data from a phase 3 trial by the National Institute of Allergy and Infectious Diseases (NIAID), which showed the drug’s use could lead to faster recovery.

Read More

BUSINESS INSIGHTS

CEM Corporation and AmbioPharm enter into US partnership for GMP peptide production

CEM Corporation | September 16, 2021

CEM Corporation and AmbioPharm, Inc. are pleased to announce the formation of a partnership to produce GMP peptides for the global market. The partnership includes the exclusive 1Use of CEM's microwave peptide synthesis technology on a large scale for the production of GMP peptides up to several kilograms using its own scalable reactors. The main advantages of this new relationship are the extremely short production times, the ability to efficiently produce more difficult peptide sequences, and the ability to incorporate green chemistry protocols. This partnership will enable the rapid and efficient production of new chemical peptide entities (NCEs) using the latest available technologies. With this agreement, AmbioPharm has started peptide synthesis at its North Augusta facility to better serve customers with fast microwave synthesis processes. CEM's peptide production technology utilizes automated, large-scale microwave solid phase peptide synthesis systems (SPPS) that have been proven to improve peptide purity and minimize excess reagents. In addition, the CEM has developed proprietary coupling methods optimized for reactions at elevated temperatures 2 , a unique way to combine the coupling and deprotection reactions in a single step 3 , and established the use of more environmentally friendly solvents that are more accessible at elevated temperatures 4 . These unique technological advantages are licensed to AmbioPharm for GMP production. AmbioPharm is a recognized leader in cGMP peptide production. The company employs more than 675 people and recently completed a major expansion of its headquarters in South Carolina, USA, adding nearly 56,000 square feet of additional peptide manufacturing capacity. The production plant has a cleaning capacity of up to 30 kg / batch and a freeze-drying capacity of up to 1,000 liters. The CEM Liberty Pro Synthesizer offers different reactor sizes (3, 8 and 15 liters) that allow the synthesis of batches from 5 g to 500 g of the final peptide. Peptide-based drugs have enormous potential for the future and we are pleased to be able to help improve their production process. AmbioPharm is an ideal partner and we believe this relationship will enhance the opportunities for the manufacturing of peptide therapeutics. - Michael J. Collins, Ph.D., President and CEO of CEM Corporation. With the addition of CEM's microwave technology to our GMP peptide manufacturing options, we can offer even better service in terms of faster delivery for our partners' products and unique opportunities to make longer and more complex peptides accessible using microwave methods. - Chris Bai, Ph.D., CEO of AmbioPharm Inc. About CEM CEM Corporation, a privately held company based in Matthews, North Carolina, is a leading provider of laboratory instruments. The company has subsidiaries in the UK, Germany, Italy, France, Japan and Singapore and a worldwide network of distributors. CEM designs and manufactures systems for life sciences, analytical laboratories and processing plants worldwide. The company's products are used in many industries, including the pharmaceutical, biotech, chemical and food industries, as well as academic research. About AmbioPharm, Inc . AmbioPharm, part of the Ambio Pharmaceuticals Group, is a leading, innovation-driven company that specializes in the development and manufacture of peptides and peptide-like products. AmbioPharm offers a comprehensive range of services and produces customized products for research, clinical development and commercial use for pharmaceutical and biotechnology companies worldwide. AmbioPharm operates internationally, has its headquarters in the USA, locations in Europe, the USA and Asia and has more than 14 years of experience and expertise.

Read More