Red River Biorefinery Now Producing Pharmaceutical Grade (USP) Ethanol for Hand Sanitizers and Disinfectants

The Red River Biorefinery (RRB) announced today that it has expanded production to supply ethanol that meets the U.S. Pharmacopeia (USP) purity and quality standards to the hand sanitizer market. To help meet the increase in global demand for hand sanitizer products due to COVID-19, RRB is now supplying hand sanitizer manufacturers with safe, high-quality ethanol products with one of the lowest carbon footprints available on the market today. It is extremely gratifying to have a local producer supplying safe ingredients for hand sanitizers while providing local jobs to support our communities. The Red River Biorefinery serves a vital role in the region's value-added agricultural, energy, and low carbon economies," said James Leiman, Director of Economic Development and Finance Division for the State of North Dakota.

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Exclusive Agreement: Specialised Therapeutics & Ascendis Pharma to Distribute Three Endocrinology Therapies in Australia & Select SE Asia Countries

PR Newswire | January 08, 2024

Independent biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) has added three new endocrinology therapies to its specialist portfolio, following an exclusive distribution agreement with Danish company Ascendis Pharma A/S. Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFA (lonapegsomatropin), hypoparathyroidism treatment YORVIPATH (palopegteriparatide) and investigational achondroplasia therapy TransCon CNP (navepegritide). The agreement spans ST's key regions of Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam. Two of the products included in this agreement are already internationally approved: Once-weekly SKYTROFA is a human growth hormone (hGH) approved in the United States for the treatment of paediatric patients aged >1 years weighing >11.5 kg with growth failure due to inadequate secretion of endogenous growth hormone (GH)1 and in the European Union for growth failure in children and adolescents aged from 3 to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]). YORVIPATH is a first-in-class parathyroid hormone (PTH) replacement therapy to treat chronic hypoparathyroidism, a rare and potentially serious condition where the body produces no or abnormally low levels of PTH. It is approved in the European Union for the treatment of adults with chronic hypoparathyroidism. The third product – TransCon CNP – is in development by Ascendis Pharma for the treatment of achondroplasia (ACH), the most common genetic form of skeletal dysplasia and resulting disproportionate short stature, following successful Phase 2 trial results. Australian endocrinologist Dr Veronica Preda noted that YORVIPATH would be the first specialist therapeutic option for Australian patients living with hypoparathyroidism. "Hypoparathyroidism can seriously impact quality of life and has potentially life-threatening consequences," Dr Preda said. "To have an option that is able to treat the underlying cause of the disease, moving beyond standard oral calcium and active Vitamin D, is a great step forward." Announcing the partnership, ST Chief Executive Officer Carlo Montagner said this agreement was an important company milestone, signalling ST's expansion into both endocrinology and paediatric medicine. Mr Montagner commented: "We are delighted to have been selected as Ascendis Pharma's exclusive partner for commercialising their portfolio in Oceania and these South-East Asia countries and look forward to launching these critical endocrinology products in our regions as soon as possible. "All three products are valuable inclusions to our broad therapeutic pipeline and our international business, as we continue to leverage our substantial experience commercialising specialist medicines across multiple regions. "We look forward to working with endocrinologists across our territories to make these endocrine therapies available to all eligible patients who may benefit." Ascendis Pharma Executive Vice President and Chief Commercial Officer Camilla Harder Hartvig said ST had been selected to launch the endocrinology portfolio in these countries based on its strong track record commercialising specialist products in multiple regions. "We are delighted to partner with Specialised Therapeutics to broaden the reach of our endocrinology rare disease portfolio, contributing to our shared goal of making a meaningful difference for patients facing unmet medical needs," she said. About Specialised Therapeutics Founded in 2007, Specialised Therapeutics is the region's largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA).

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ValGenesis VLMS to Drive Digital Transformation for Leading Spanish Pharmaceutical Company

PR Newswire | January 03, 2024

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IDBS announces data management partnership with PharmaEssentia Innovation Research Center

PR Newswire | January 24, 2024

IDBS announced today that it has entered into a partnership with Massachusetts-based PharmaEssentia Innovation Research Center (PIRC) on its Polar platform to help digitize data management and facilitate collaboration between the company's global research and development (R&D) teams. The Polar platform will provide PIRC, the newly established U.S. hub of PharmaEssentia's R&D efforts, the ability to electronically collaborate with its team headquartered in Taipei, Taiwan, who have traditionally recorded experimental data on paper. "The IDBS Polar platform provides superior functionality beyond traditional Electronic Laboratory Notebook (ELN) offerings, backed up by our broad customer base and customer support, as well as the ability to support languages like Mandarin," said Pietro Forgione, General Manager at IDBS. "We are proud to help PIRC better capture, structure and interrogate their key data from a single source of truth, thereby making their collaboration more efficient." "We are looking forward to partnering with IDBS, not only to implement the Polar platform to help us manage our data more efficiently and to more seamlessly collaborate with our R&D team in Taipei, but also to work together to further explore ways to bring our innovative therapeutics to market faster," said Lih-Ling Lin, Ph.D., PIRC Founder and Chief Scientific Officer, PharmaEssentia. About IDBS IDBS helps BioPharmaceutical organizations accelerate the discovery, development and manufacturing of the next generation of life-changing therapies that advance human health worldwide. From lab through manufacturing, IDBS leverages its 30+ years of experience working with a diverse list of customers – including 18 of the top 20 global BioPharma companies – and deep expertise in scientific informatics and process data management to tackle today's most complex challenges. Known for its signature IDBS E-WorkBook product, IDBS has extended solutions across the entire value chain for BioPharma Lifecycle Management (BPLM). Built on analytics-centric and cloud-native technology, IDBS Polar and IDBS PIMS platforms are powered by a digital data backbone to drive faster and smarter decisions in drug development and across the supply chain.

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